Drug Information Update - PerformRx Information Update March...aliskiren hemifumarate 150 mg, 300 mg...

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Drug Information Update March 2019

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TABLE OF CONTENTS

TABLE OF CONTENTS ............................................................................... 1

NEWLY AVAILABLE GENERICS ................................................................. 2

NEW DRUG ENTITIES/COMBINATIONS/STRENGTHS ............................... 3

NEW INDICATIONS (EXISTING DRUGS) .................................................... 5

FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS .............................. 8

STUDIES AND RECENT TOPICS ............................................................... 16

RECALLS ................................................................................................ 20

CURRENT DRUG SHORTAGES .............................................................. 124



NEWLY AVAILABLE GENERICS

GENERIC DRUG NAME STRENGTH &

DOSAGE FORM GENERIC

MANUFACTURER BRAND NAME

TREPROSTINIL SODIUM

1 MG/ML, 2.5 MG/ML, 5 MG/ML,

10 MG/ML VIAL

SANDOZ REMODULIN

VIT E/LIDOCAINE/ALOE/COLLAGEN 2 % GEL MPM MEDICAL REGENECARE

RANOLAZINE 500 MG,

1000 MG ER TABLET

LUPIN PHARMACEUTICAL

RANEXA

BENZHYDROCODONE/ ACETAMINOPHEN

6.12 MG-325 MG, 8.16 MG-325 MG, 4.08 MG-325 MG

TABLET

KVK-TECH, INC. APADAZ

CYCLOBENZAPRINE HCL 15 MG,

30 MG ER CAPSULE

TEVA USA, IMPAX/AMNEAL,

TWI PHARMACEUTICAL

AMRIX

CINACALCET HCL 30 MG, 60 MG,

90 MG TABLET

CIPLA USA, INC. SLATE RUN PHARM

SENSIPAR

GELATIN SPONGE, ABSORB/PORCINE 100 CM SPONGE PHARMACI/PFIZER

ETHICON GELFOAM

COMPRESSED

GELATIN SPONGE, ABSORB/PORCINE 12-7 MM SPONGE PHARMACI/PFIZER

ETHICON GELFOAM

LIDOCAINE HCL 4% GEL W/PUMP GENSCO

LABORATORY ASTERO

DICLOFENAC EPOLAMINE 1.3% PATCH TEVA USA

GREENSTONE LLC. FLECTOR

ALISKIREN HEMIFUMARATE 150 MG,

300 MG TABLET PRASCO LABS TEKTURNA

METHEN/MBLUE/SAL/ SOD PHOS/HYOS

120 MG-10 MG-36 MG-40.8 MG-0.12

MG CAPSULE BIOCOMP PHARMA USTELL

PYRIDOSTIGMINE BROMIDE 60 MG/5 ML

SYRUP NOVITIUM PHARMA

MESTINON



NEW DRUG ENTITIES/COMBINATIONS/STRENGTHS

DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

ANTIPSORIATIC AGENTS, SYSTEMIC

TREMFYA GUSELKUMAB 100 MG/ML AUTO INJCT

New Dosage Form

THYROID HORMONES TIROSINT-SOL LEVOTHYROXINE

SODIUM

13 MCG/ML 25 MCG/ML 50 MCG/ML 75 MCG/ML 88 MCG/ML

100 MCG/ML 112 MCG/ML 125 MCG/ML 137 MCG/ML 150 MCG/ML 175 MCG/ML 200 MCG/ML

ORAL SOLUTION

New Dosage Form

OPIOID ANTITUSSIVE-1ST GENERATION ANTIHISTAMINE

TUXARIN ER CHLORPHENIRAMINE

/CODEINE PHOS 8MG-54.3MG

TABLET ER 12H New

Combination

LEUKOCYTE (WBC) STIMULANTS

NIVESTYM FILGRASTIM-AAFI 300 MCG/ML VIAL 480MCG/1.6 VIAL

New Strength, New Dosage

Form

EYE ANTI-INFLAMMATORY

AGENTS LOTEMAX SM

LOTEPREDNOL ETABONATE

0.38 % DROPS GEL

New Strength

AGENTS TO TX THROMBOTIC

THROMBOCYTOPENIC PURPURA

CABLIVI CAPLACIZUMAB-

YHDP 11 MG KIT New Entity

ANTINEOPLASTIC-CD123-DIRECTED

CYTOTOXIN CONJUGATE ELZONRIS TAGRAXOFUSP-ERZS

1000 MCG/ML IV SOLUTION

New Entity

ANTIDEPRESSANT - NMDA RECEPTOR

ANTAGONIST SPRAVATO ESKETAMINE HCL

56 MG, 84 MG NASAL SPRAY

New Entity

HEMORRHOID PREP, ANTI-INFLAM STEROID-

LOCAL ANESTHET

LIDOCAINE-HYDROCORT-

ISONE

LIDOCAINE/ HYDROCORTISONE

AC

2%-2% KIT (CREAM, WIPES)

New Strength

TOPICAL PREPARATIONS,ANTIBAC

TERIALS SOLOX GEL SILVER NITRATE 55 PPM GEL

New Dosage Form & Strength

OPHTHALMIC PREPARATIONS, MISCELLANEOUS

HEALON ENDOCOAT

HYALURONATE SODIUM

30 MG/ML INTRAOCULR

SYRINGE New Strength



DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

NSAIDS, CYCLOOXYGENASE INHIBITOR - TYPE

ANALGESICS

QMIIZ ODT MELOXICAM 7.5 MG, 15 MG TABLET RAPDIS

New Dosage Form

ANTI-PROGRAMMED CELL DEATH-LIGAND 1

(PD-L1) MAB TECENTRIQ ATEZOLIZUMAB

840 MG/14 ML VIAL

New Package Size

IMMUNOSUPPRESSIVES PROGRAF TACROLIMUS 0.2 MG, 1 MG

ORAL GRANULE PACK

New Dosage Form and Strength



NEW INDICATIONS (EXISTING DRUGS)

LONSURF®

February 25, 2019

Taiho Oncology, Inc. today announced that the United States Food and Drug Administration (FDA) has

approved LONSURF® as a treatment for adult patients with metastatic gastric or gastroesophageal

junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included

a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted

therapy.

Source: Taiho Oncology, Inc.

SOLIQUA® 100/33

February 27, 2019

The U.S. Food and Drug Administration (FDA) has approved the expanded use of Soliqua® 100/33

(insulin glargine and lixisenatide injection) 100 Units/mL and 33 mcg/mL. Previously approved for use as

an add-on to diet and exercise in adults with type 2 diabetes who are uncontrolled on long-acting insulin

or lixisenatide, Soliqua 100/33 can now also be prescribed for patients uncontrolled on oral antidiabetic

medicines.

Source: Sanofi

HERCEPTIN HYLECTA™

February 28, 2019

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S.

Food and Drug Administration (FDA) has approved Herceptin Hylecta™ (trastuzumab and hyaluronidase-

oysk) for subcutaneous (under the skin) injection for the treatment of certain people with HER2-positive

early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature)

in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with

paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic

disease. This new treatment includes the same monoclonal antibody as intravenous Herceptin®

(trastuzumab) in combination with recombinant human hyaluronidase PH20, an enzyme that helps to

deliver trastuzumab under the skin. Herceptin Hylecta is a ready-to-use formulation that can be

administered in two to five minutes, compared to 30 to 90 minutes for intravenous Herceptin.

Source: Genentech



ADHANSIA XR™

March 1, 2019

Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced that the U.S. Food and Drug

Administration (FDA) approved Adhansia XR™ (methylphenidate hydrochloride) extended-release

capsules CII, a central nervous system (CNS) stimulant, for the treatment of Attention-

Deficit/Hyperactivity Disorder (ADHD) in patients six years and older. In a simulated Adult Workplace

Environment (AWE) study, Adhansia XR demonstrated statistically significant improvement over placebo

at 1, 2, 5, 8, 11, and 16 hours post-dose, but not at hour 14 post-dose.

Source: Adlon Therapeutics L.P.

SPRAVATO™

March 5, 2019

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug

Administration (FDA) has approved SPRAVATO™ (esketamine) CIII nasal spray for use in conjunction with

an oral antidepressant in adults with treatment- resistant depression (TRD). People who are currently

struggling with major depressive disorder (MDD) are considered to have TRD if they have not responded

adequately to at least two different antidepressants of adequate dose and duration in the current

depressive episode. It is estimated that approximately one-third of U.S. adults with MDD have TRD.4

SPRAVATO™ carries a Boxed WARNING regarding a Risk Evaluation and Mitigation Strategy (REMS) and

the risk of suicidal thoughts and behaviors in pediatric patients and young adults.

Source: Janssen Pharmaceutical Companies

TECENTRIQ®

March 8, 2019

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S.

Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq® (atezolizumab) plus

chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-

bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or metastatic

triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, as determined by an FDA-

approved test. This indication is approved under accelerated approval based on progression-free

survival (PFS). Continued approval for this indication may be contingent upon verification and

description of clinical benefit in a confirmatory trial(s). The FDA’s Accelerated Approval Program allows

conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening

disease or condition.

Source: Genentech



DUPIXENT®

March 11, 2019

The U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for adolescent

patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not

adequately controlled with topical prescription therapies, or when those therapies are not advisable.

Dupixent can be used with or without topical corticosteroids.

Source: Sanofi



FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS

Losartan distributed by Macleods Pharmaceuticals voluntarily recalled

[Posted 2/25/2019]

FDA is alerting patients and health care professionals to a voluntary recall of one lot of losartan

potassium/hydrochlorothiazide (HCTZ) 100mg/25mg combination tablets manufactured by Macleods

Pharmaceuticals. The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) found in

the medicine made with active pharmaceutical ingredient manufactured by Hetero Labs Limited.

Macleods is only recalling lots of losartan-containing medication where NDEA has been detected above

the interim acceptable intake limit of 0.27 parts per million. FDA is working with manufacturers to

reduce and remove nitrosamines from angiotensin II receptor blockers (ARBs).

The agency also updated the list of losartan products under recall.

Source: U.S. Food and Drug Administration (FDA)

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

[Posted 2/25/2019]

ISSUE: FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis

BACKGROUND: When FDA first approved tofacitinib, we required a clinical trial among patients with RA

to evaluate the risk of heart-related events, cancer, and opportunistic infections with the medicine at

two doses (10 mg twice daily and 5 mg twice daily) in combination with methotrexate in comparison to

another drug called a tumor necrosis factor (TNF) inhibitor. RA patients in the trial were required to be

at least 50 years old and have at least one cardiovascular risk factor. During the most recent analysis of

the trial, an external data safety monitoring committee found an increased occurrence of blood clots in

the lungs and death in patients treated with tofacitinib 10 mg twice daily compared to patients treated

with tofacitinib 5 mg twice daily or a TNF inhibitor.

RECOMMENDATION: Health care professionals should follow the recommendations in the tofacitinib

prescribing information for the specific condition they are treating. Monitor patients for the signs and

symptoms of pulmonary embolism, and advise them to seek medical attention immediately if they

experience them.

Patients should not stop or change your dose of tofacitinib without first talking to your health care

professional, as doing so may worsen your condition. Patients taking tofacitinib should seek medical

https://www.fda.gov/Safety/Recalls/ucm631880.htm

https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm#interimlimits

https://www.fda.gov/downloads/Drugs/DrugSafety/UCM628993.pdf



attention immediately if you experience symptoms of a blood clot in your lungs or other unusual

symptoms such as:

Sudden shortness of breath or difficulty breathing

Chest pain or pain in your back

Coughing up blood

Excessive sweating

Clammy or bluish colored skin

Healthcare professionals and patients are encouraged to report adverse events or side effects related to

the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting

Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to

the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


FDA updates table of interim limits for nitrosamine impurities in ARBs

[Posted 2/28/2019]

FDA is posting the updated table of interim acceptable intake limits for nitrosamine impurities to reflect

N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) limits, which are the same as those for NDMA.

The agency will use the interim limits below to recommend manufacturers conduct a voluntary recall if

laboratory testing confirms the presence of nitrosamine impurities in finished drug product. FDA is

working with industry and international regulators to ensure products entering the market do not

contain these impurities, but we are tolerating the impurities below the level established in the table for

a short period of time to avoid a possible shortage of ARBs.

Not all ARB products contain NDMA, NDEA or NMBA impurities, so pharmacists may be able to provide

an alternative medication not affected by the recalls, or health care professionals may prescribe a

different medication that treats the same condition.

Interim Limits for NDMA, NDEA, and NMBA in Angiotensin II Receptor Blockers (ARBs)

Drug Maximum Daily Dose (mg/day)

Acceptable Intake NDMA (ng/day)*

Acceptable Intake NDMA (ppm)**

Acceptable Intake NDEA

(ng/day)*

Acceptable Intake NDEA

(ppm)**

Acceptable Intake NMBA

(ng/day)*

Acceptable Intake NMBA

(ppm)**

Valsartan 320 96 0.3 26.5 0.083 96 0.3 Losartan 100 96 0.96 26.5 0.27 96 0.96

Irbesartan 300 96 0.32 26.5 0.088 96 0.32 Azilsartan 80 96 1.2 26.5 0.33 96 1.2

http://www.fda.gov/MedWatch/report



Olmesartan 40 96 2.4 26.5 0.66 96 2.4 Eprosartan 800 96 0.12 26.5 0.033 96 0.12 Candesarta

n 32 96 3.0 26.5 0.83 96 3.0

Telmisartan 80 96 1.2 26.5 0.33 96 1.2

* The acceptable intake is a daily exposure to a compound such as NDMA, NDEA, or NMBA that

approximates a 1:100,000 cancer risk after 70 years exposure

** These values are based on a drug's maximum daily dose as reflected in the drug label

FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and

irbesartan

Torrent again expands its voluntary recall of losartan; Hetero also voluntarily recalls losartan

[Posted 3/1/2019]

Torrent Pharmaceuticals Limited is further expanding its voluntary recall to include 114 additional lots of losartan potassium and losartan potassium/hydrochlorothiazide combination tablets. This recall is due to unacceptable amounts of N-Methylnitrosobutyric acid (NMBA) in the losartan active pharmaceutical ingredient manufactured by Hetero Labs Limited.

Today, the agency also issued a press release to provide additional information about its ongoing investigation and another voluntary recall by Hetero/Camber Pharmaceuticals, which was announced on February 28, of 87 lots of losartan potassium tablets (25 mg, 50 mg and 100 mg). The recalled losartan potassium and losartan potassium/hydrochlorothiazide tablets are also manufactured by Hetero, which are distributed by Camber, and contain the impurity NMBA.

Torrent and Hetero/Camber are only recalling lots of losartan-containing medication with NMBA above the interim acceptable intake limits of 0.96 parts per million (ppm).

The agency also updated the list of losartan products under recall.

Aurobindo expands its voluntary recall of valsartan and amlodipine/valsartan

[Posted 3/1/2019]

AurobindoPharma USA is expanding its voluntary recall to include 38 additional lots of valsartan and

amlodipine/valsartan combination tablets. The recall is due to unacceptable amounts of N-

Nitrosodiethylamine (NDEA) found in the medicine.

Aurobindo is only recalling lots of valsartan-containing medication where NDEA has been detected

above the interim acceptable intake limit of 0.083 parts per million. FDA is working with manufacturers

to reduce and remove nitrosamines from angiotensin II receptor blockers (ARBs).

The agency also updated the valsartan products under recall.


https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632425.htm?utm_campaign=030119_PR_FDA%20update%20on%20investigation%20into%20ARB%20drugs%3B%20new%20losartan%20recall&utm_medium=email&utm_source=Eloqua

https://www.fda.gov/drugs/drugsafety/ucm613916.htm?utm_campaign=FDA%20MedWatch%20Alert%20on%20Angiotensin%20II%20Receptor%20Blocker%20Including%20Valsartan%20and%20Losartan&utm_medium=email&utm_source=Eloqua&interimlimits2



https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm#interimlimits




Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement

[Posted 3/4/2019]

Weston, Florida, Apotex Corp. is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP to the patient /user level. The four recalled lots of Drospirenone and Ethinyl Estradiol Tablets, USP may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket. The affected product is manufactured by Oman Pharmaceutical Products Co. LLC. Oman under the subcontract from Helm AG, Nordkanalstrasse 28, Hamburg, 20097, Germany.

Risk Statement : As a result of this packaging error, where a patient does not take a tablet due to a missing tablet or that a patient takes a placebo instead of an active tablet, loss of efficacy is possible due to variation in the dosage consumed. To date, no case has been reported for pregnancy and adverse event to Apotex.

Patients who have received impacted lots of Drospirenone and Ethinyl Estradiol Tablets, USP 3 MG/0.03 MG or have questions regarding this recall please contact your pharmacy. Individuals should not interrupt their therapy, use a non-hormonal method of birth control, contact their health care provider for medical advice and may return the impacted packages to their pharmacist.

Drospirenone and Ethinyl Estradiol Tablets, USP are an estrogen/progestin COC indicated for use by women to prevent pregnancy. Drospirenone and ethinyl estradiol tablets (inner carton) consists of 28 film-coated, biconvex tablets in the following order: 21 yellow color tablets, each containing 3 mg drospirenone (DRSP) and 1.3 mg ethinyl estradiol (EE), and 7 placebo white color tablets. The affected Drospirenone and Ethinyl Estradiol Tablets, USP lots include the following and can be identified by NDC numbers stated on the inner and outer cartons:

NDC number on outer carton

NDC Number on inner carton

Lot Number

Expiration Date

Strength

Configuration/Count

60505-4183-03

60505-4183-01

7DY008A

7DY009A

7DY010A

7DY011A

08/2020

3 MG/

0.03 MG

Outer Carton: Contains three inner Cartons Inner Carton: Contains 1 blister with 21 active yellow color tablets and 7 placebo white color tablets.

The affected Drospirenone and Ethinyl Estradiol Tablets were distributed Nationwide to wholesalers and distributors.

Apotex Corp. has notified its affected wholesalers and distributors via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product. Patients / users that have the affected lots of Drospirenone and Ethinyl Estradiol Tablets, USP which are being recalled should consult with their healthcare provider.

Wholesalers, Distributors and Retailers return the impacted product to place of purchase. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Customers who



purchased the impacted product directly from Apotex can call GENCO at 1- 877-674-2082 (7:00am – 5:00pm, CST Monday thru Friday), to arrange for their return.

Consumers with questions regarding this recall can contact Apotex corp. by phone-number 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address [email protected] . Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online : www.fda.gov/medwatch/report.htm

Regular Mail or Fax : Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to

the Presence of Particulate Matter

[Posted 3/15/2019]

Hospira, Inc., a Pfizer company, is voluntarily recalling lot numbers 79-238-EV, 79-240-EV and 80-088-EV,

NDC# 0409-6625-02, of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL), to the

Hospital/Institution level. The recall was initiated due to the presence of particulate matter, confirmed

as glass.

The administration of a glass particulate, if present in an intravenous drug, may result in local irritation

or swelling in response to the foreign material. More serious potential outcomes would include blockage

and clotting in blood vessels, which may be life-threatening if a critical organ is affected. To date,

Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots. The

risk is reduced by the possibility of detection, as the label contains a clear statement directing the

healthcare professional to visually inspect the product for particulate matter and discoloration prior to

administration.

The 8.4% Sodium Bicarbonate Injection, USP, is a sterile, hypertonic solution of sodium bicarbonate

(NaHCO3) in water for administration by the intravenous route. It is indicated for the treatment of

metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, dehydration, severe

diarrhea, circulatory insufficiency due to shock, cardiac arrest and severe lactic acidosis. Sodium

bicarbonate is also indicated for the treatment of certain drug intoxications.

8.4% Sodium Bicarbonate Injection, USP, NDC# 0409-6625-02, is packaged in 50 mL glass fliptop vials in

a case pack of 4 x 25- 50mL. The affected lots and their expiry dates are indicated in the table below.

mailto:[email protected]

http://www.fda.gov/MedWatch/report.htm



Product was distributed Nationwide to Wholesalers/Distributors/Hospitals in the United States and

Puerto Rico from August 2017 to September 2017.

NDC Lot Number Expiration Date Strength Configuration/Count

00409-6625-02 79-238-EV 1JUL2019 50 mEq/50 mL Case Pack 4 x 25, 50 mL

00409-6625-02 79-240-EV 1JUL2019 50 mEq/50 mL Case Pack 4 x 25, 50 mL

00409-6625-02 80-088-EV 1AUG2019 50 mEq/50 mL Case Pack 4 x 25, 50 mL

Hospira, Inc. places the utmost emphasis on patient safety and product quality at every step in the

manufacturing and supply chain process. Hospira, Inc. has notified its direct customers via a recall letter

to arrange for return of any recalled product.

Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine

immediately. Inform Healthcare Professionals in your organization of this recall. For additional

assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through

Friday.

For clinical inquiries, please contact Hospira/Pfizer using the below information.

Contact Contact Information Areas of Support

Pfizer Medical Information 1-800-438-1985, option 3 (8 am to 7 pm Monday through Friday)

Medical inquiries

Pfizer Safety 1-800-438-1985, option 1 (24 hours a day, 7 days per week)

To report adverse events or product complaints

Adverse reactions or quality problems experienced with the use of this product may be reported to the

FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088

to request a reporting form, then complete and return to the address on the pre-addressed form, or

submit by fax to 1-800-FDA-0178.

This recall is being executed with the knowledge of the U.S. Food and Drug Administration.


Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium

Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl

4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmaceutical Ingredient (API)

[Posted 3/19/2019]

Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg,

50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc.

issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of



N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an

active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

NMBA is a potential human carcinogen. To date, Legacy has not received any reports of adverse events

related to this recall.

Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive

heart failure and is packaged in 30ct bottles. The identifying NDC numbers associated with Legacy’s

product are as follows:

Losartan Potassium, USP, 25mg NDC 68645-577-54 Losartan Potassium, USP, 50mg NDC 68645-578-54

Losartan Potassium, USP, 100mg NDC 68645-579-54

The affected Losartan Potassium includes 40 repackaged lots numbers which are listed below:

Legacy NDC# Name and Strength Count Legacy Lot# Expiry

68645-577-54 Losartan Potassium Tablets USP 25 mg 30 180952 10/2019










































The product can be identified by checking the product name and repackaged lot number on the bottle

containing these products.

Losartan Potassium was distributed by pharmacies nationwide. Legacy Pharmaceutical Packaging LLC is

notifying its distributors and customers in writing and is arranging/assisting for return of all recalled

products to (a) For Distribution Center Level, please return the products to Legacy Pharmaceutical

Packaging LLC; (b) For Retail Level, please return the products to Genco; or (c) For Consumer Level,

please return the products to the dispensing pharmacy, whichever is applicable. Instructions for

returning recalled products are provided in the recall letter.

Consumers with questions regarding this recall can contact your dispensing pharmacy during normal

business hours. Consumers should contact their physician or healthcare provider if they have

experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the

FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then

complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.




STUDIES AND RECENT TOPICS

Silver health plans set stiffer cost-sharing on drugs than employer plans

March 1, 2019

Two new studies show how health plans are jacking up patients' out-of-pocket costs for prescription

drugs. The studies highlight some of the concerns raised during Tuesday's Senate Finance Committee

hearing featuring the CEOs of seven major pharmaceutical manufacturers.

Source: modernhealthcare.com

Lidose-Isotretinoin Sustains Long-Term Acne Benefit Without Food Intake

March 4, 2019

A new study shows that a twice-daily treatment of lidose-isotretinoin administered without food is

associated with decreased lesions and condition severity in patients with nodular acne.

In new data presented at the American Academy of Dermatology (AAD) 2019 Annual Meeting in

Washington, DC, this week, investigators Andrea Zaenglein, MD, and James Del Rosso, DO, showed that

common acne therapy isotretinoin was associated with significant and sustained improvements to

symptoms and metrics for quality of life (QoL).

Source: mdmag.com

Health Systems Share Their Approaches to Improve Patient Engagement

March 5, 2019

Health systems are actively developing consumer technologies to help patients better manage their

health, and a recent report involving several of these health systems revealed some novel ways to

accomplish this goal.

Using patient-centered health care technologies, these health sytems were able to deliver positive

measurable outcomes for patients, researchers reported in the March issue of Health Affairs.

Source: pharmacytimes.com



FDA finalizes guidance for compounding bulk substances

March 5, 2019

FDA issued final guidance for outsourcing facilities that make drugs using bulk substances. The guidance,

Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the

Federal Food, Drug, and Cosmetic Act, outlines a framework FDA will use to determine when there is a

clinical need for facilities to make drugs using bulk substances. FDA said the new measures are being set

in place to protect patients.

Source: pharmacist.com

U.S. Cities Skeptical Of FDA Warnings Against Medicine Imports From Canadian Firm

March 6, 2019

Cities and local governments in several states say they will continue to use a Canadian company to offer

employees prescription drugs at a highly reduced price, even though officials from the U.S. Food and

Drug Administration have raised safety concerns about the practice.

Source: npr.org

Patients Experiment With Prescription Drugs To Fight Aging

March 6, 2019

Dr. Alan Green’s patients travel from around the country to his tiny practice in Queens, N.Y., lured by

the prospect of longer lives.

Over the past two years, more than 200 patients have flocked to see Green after learning that two drugs

he prescribes could possibly stave off aging. One 95-year-old was so intent on keeping her appointment

that she asked her son to drive her from Maryland after a snowstorm had closed the schools.

Source: khn.org

Which Misused Prescription Meds Send Americans to the ER?

March 6, 2019

Most folks treated in a U.S. emergency room for misuse of prescription medications get into trouble

because they mix different substances, a new study reports.

Benzodiazepines like Xanax (alprazolam) and Ativan (lorazepam) are most commonly implicated in

health crises that lead to an ER visit, followed by prescription opioids, researchers found.



Source: healthday.com

Nasal spray for depression is promising, but precautions should be taken

March 9, 2019

On Tuesday March 5, the U.S. Food and Drug Administration approved a nasal spray called esketamine,

a molecular variation of ketamine, which can alleviate symptoms of treatment-resistant depression in

just a few hours. While ketamine has attracted criticism and controversy over the years, there are

numerous reasons to celebrate this development, even if it’s with some caution.

Source: thehill.com

Addiction counselor create app to fight drug overdoses

March 9, 2019

Evanston, Ill. (AP) — A former heroin user who is now an addiction counselor in suburban Chicago has

created a smartphone app that aims to prevent drug overdoses.

Lucien Izraylov, 41, has created the Harmredux app, which connects drug users with trained volunteers

who will carry overdose-reversing medication to make sure they survive drug use, The Chicago Tribune

reported. The app is available for iPhones and Androids. Source: apnews.com

Lilly's combo therapy succeeds in late-stage lung cancer study

March 12, 2019

Eli Lilly and Co’s combination cancer treatment met the main goal of a late-stage clinical trial testing it

on patients with a form of lung cancer, the drugmaker announced on Tuesday.

Previously untreated patients with metastatic non-small cell lung cancer taking a combination of Lilly’s

Cyramza and Roche’s erlotinib went longer before their disease started to worsen, study results showed.

Source: reuters.com

Are 'Inactive' Ingredients in Your Drugs Really So Harmless?

March 13, 2019

More than 90 percent of the medications that Americans take contain an inactive ingredient that could

cause an allergic reaction, a new study suggests.

Lactose, peanut oil, gluten and chemical dyes are added to drugs to improve taste, prolong shelf life,

improve absorption or make the drug tamper-proof, researchers explained. But they can also spell

trouble for patients who are allergic to those ingredients.

Source: healthday.com



Antifungal drug could help cystic fibrosis patients for whom common treatments don’t work

March 13, 2019

For one in 10 cystic fibrosis patients, current therapies don’t work, leaving them ravaged by shortness of

breath and bouts of pneumonia and other infections. Now, there hope for them in the form of a

medicine that’s already approved to fight fungal infections, researchers report today. The treatment

appears to restore healthy function in human cells affected by cystic fibrosis as well as in pigs with the

disease.

Source: sciencemag.org

Gottlieb criticizes sponsors’ ‘continued reluctance’ to rethink clinical trials

March 15, 2019

Outgoing FDA Commissioner Scott Gottlieb, M.D., has criticized the “continued reluctance” of sponsors

and CROs to adopt innovative approaches to clinical trials. Gottlieb challenged industry and academia to

invest in new approaches and realign incentives to make clinical research more agile and effective.

Source: fiercebiotech.com

FDA Accepts AR101 BLA for Peanut Allergy

March 19, 2019

The US Food and Drug Administration (FDA) has accepted Aimmune’s Biologics License Application for

AR101. The therapy is seeking approval as a treatment to reduce the risk of anaphylaxis in peanut-

allergic children and adolescents following exposure to peanut.

Source: mdmag.com



RECALLS

Product Type

Product Description Classification Code Info Reason for

Recall Recalling

Firm

Drugs

Maeng Da Kratom, packaged in a) 25 gram

powder (UPC 00859667007118), b) 50

gram powder (UPC 00859667007125), c) 100

gram powder (UPC 00859667007132), Sunstone Organics

Springfield, Oregon 97473, 541-972-3327.

Class I Lot #124A

MICROBIAL CONTAMINATIO

N OF NON-STERILE

PRODUCTS: Analysis of

samples were positive for Salmonella.

Todd Holiday

dba Sunstone Organics

Drugs

White Vein Kratom, packaged in a) 25 gram

powder (UPC 00859667007316), b) 50

gram powder (UPC 00859667007323), c) 100

gram powder (UPC 00859667007330), Sunstone Organics

Springfield, Oregon 97473, 541-972-3327.

Class I Lot #119


N OF NON-STERILE



Todd Holiday


Drugs

White Vein Kratom, packaged in a) 20 count

capsules (UPC 00859667007347), b) 60

count capsules (UPC 00859667007354), c) 150

count capsules (UPC 00859667007361), Sunstone Organics

Springfield, Oregon 97473 541-972-3327.

Class I Lot #119


N OF NON-STERILE



Todd Holiday


Drugs

Maeng Da Kratom, packaged in a) 20 count

capsules (UPC 00859667007149), b) 60

count capsules (UPC 00859667007156), c) 150

count capsules (UPC 00859667007163) , Sunstone Organics

Springfield, Oregon 97473,

Class I Lot #124A


N OF NON-STERILE



Todd Holiday




Product Type


Recall Recalling

Firm

541-972-3327.

Drugs

Dr. King's aquaflora Candida High Potency, 8 fl.

oz. (236 mL), King Bio, Inc., 3 Westside Dr.

Asheville, NC 28806 USA, UPC 35795580018, NDC

57955-8020-89

Class I

Lot Numbers: 120217R Exp.

12/19; 102017C Exp. 10/19;

101017G Exp. 10/19; 111417C

Exp. 11/19; 062818E Exp.

06/20; 122817B Exp. 12/19;

030818B Exp. 03/20; 010716A

Exp. 01/19; 011617H Exp.

01/20; 012517M Exp. 01/20;

020717A Exp. 02/20; 021816A

Exp. 02/19; 031016C Exp.

03/19; 031016D Exp. 03/19;

033016K Exp. 03/19; 052516J

Exp. 05/19; 052918G Exp.

05/20; 062116A Exp. 06/19;

062818A Exp. 06/20; 062818F

Exp. 06/20; 090816B Exp.

06/20; 101216A Exp. 10/19;

112315A Exp. 11/18; 112916C

Exp. 11/19; 120816N Exp.

12/19

Microbial contamination

King Bio Inc.

Drugs

Dr. King's Lymph Detox, 2 fl. oz. (59 mL), King Bio,

Inc., 3 Westside Dr. Asheville, NC 28806, UPC

357955506324, NDC

Class I

Lot Numbers: 081815F Exp.

08/18; 030916V Exp. 03/19;

061316B Exp.


King Bio Inc.



Product Type


Recall Recalling

Firm

57955-5063-2 06/19; 1208016H Exp. 12/19;

010118BE Exp. 01/01/20;

041017M Exp. 04/19

Drugs

Dr. King's Natural Medicine Homeopathic Male Libido, 2 fl. oz. (59

mL), King Bio, Inc. 3 Westside Dr. Asheville, NC

28806, UPC 3579555101022, NDC

57955-5510-2

Class I


03/19; 051216K Exp. 05/19;

080315E Exp. 08/2018; 080916Q

Exp. 08/2019; 120816E Exp.

12/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic

Regional Allergies Northeastern U.S., 2 fl. oz.

(59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC

28806, UPC 357955519225, NDC

57955-0753-2

Class I

Lot Numbers: 030817M Exp.

03/19; 050216E Exp. 05/19;

070816D Exp. 07/19; 010118D

Exp. 01/20; 030418B Exp.

03/20


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Regional Allergies Rocky Mtns. U.S., 2 fl. oz. (59

mL), King Bio, Inc., 3 Westside Dr. Asheville, NC

28806, UPC 357955518624, NDC

57955-0200-2

Class I

Lot Numbers: 0301817L Exp.

03/19; 030916G Exp. 03/19;

052615C Exp. 05/18; 080116B

Exp. 08/19; 091015T Exp.

09/18


King Bio Inc.

Drugs


Cold Sores & Herpes, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,

NC 28806, UPC 357955516521, NDC

57955-5165-2

Class I

Lot Numbers: 030218B Exp.

03/20; 033116H Exp. 03/19;

061815J Exp. 06/18; 062716B

Exp. 06/19; 091616C Exp.

09/19; 111017B Exp. 11/19;

123015A Exp. 12/18


King Bio Inc.



Product Type


Recall Recalling

Firm

Drugs


Menstrual Cramps & Irregularities 2 fl. oz. (59


28806, UPC 357955500421, NDC

57955-5004-02

Class I

Lot Numbers: 041416J Exp.

04/19; 070816F Exp. 07/19;

091015K Exp. 09/2018; 030218C

Exp. 03/20


King Bio Inc.

Drugs


Regional Allergies Pacific U.S. 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr.

Asheville, NC 28806, UPC 357955519324, NDC

57955-8198-2

Class I

Lot Numbers: 030816C Exp.

03/19; 052616C Exp. 05/19;

062215K Exp. 06/18; 012518B

Exp. 01/20; 040218B Exp.

04/20; 050417A Exp. 05/19;

030817P Exp. 03/19


King Bio Inc.

Drugs


Bladder Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3

Westside Dr. Asheville, NC 28806, UPC

357955504528, NDC 57955-1503-2

Class I

Lot Numbers: 022616A Exp.

02/19; 030218D Exp. 03/20;

050216AC Exp. 05/19; 072216K

Exp. 07/19; 083115H Exp.

08/18; 120717A Exp. 12/19;

123015C Exp. 12/18


King Bio Inc.

Drugs


Regional Allergies Southern U.S., 2 fl. oz. (59


28806, UPC 357955518426, NDC

57955-0760-2

Class I

Lot Numbers: 022717K Exp.

02/20; 030816D Exp. 03/19;

030817R Exp. 03/19; 061815H

Exp. 06/18; 030418A Exp.

03/20


King Bio Inc.

Drugs Dr. King's Natural

Medicine Homeopathic Heart Regularity, 2 fl. oz.

Class I Lot Numbers: 030718F Exp.

03/20; 051716N


King Bio Inc.



Product Type


Recall Recalling

Firm


28806, UPC 357955506522, NDC

57955-5065-2

Exp. 05/19; 080916K Exp.

08/19

Drugs

Dr. King's Natural Medicine Homeopathic Heartburn Reliever, 2 fl.

oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,

NC 28806, UPC 357955502227, NDC

57955-5022-2

Class I

Lot Numbers: 020817H Exp.

02/20; 030816A Exp. 03/19;

050216B Exp. 05/19; 061616B

Exp. 06/19; 072115C Exp.

07/18


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Regional Allergies Plains

U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr.


57955-8199-2

Class I


03/19; 030817H Exp. 03/19;

092815A Exp. 09/18; 010118C

Exp. 01/20


King Bio Inc.

Drugs


Regional Allergies Desert U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr.


57955-8196-2

Class I

Lot Numbers: 030916Q Exp.

03/19; 052616A Exp. 05/19;

072516J Exp. 07/19; 072815B

Exp. 07/18; 012918A Exp.

01/20; 030817J Exp. 03/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Regional Allergies Great Lakes U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3


357955519027, NDC 57955-8195-2

Class I


03/19; 030916H Exp. 03/19;

061615F Exp. 06/18; 071416B

Exp. 07/19; 022618J Exp.

02/20


King Bio Inc.

Drugs


Regional Allergies Southwestern U.S., 2 fl.

Class I


01/20; 020117B Exp. 02/20;


King Bio Inc.



Product Type


Recall Recalling

Firm


NC 28806, UPC 357955518921, NDC

57955-8202-2

022717J Exp. 02/20; 030817N

Exp. 03/19; 031417A Exp.

03/20; 041416H Exp. 04/19;

111016C Exp. 11/19; 122915C

Exp. 12/18

Drugs

Dr. King's Natural Medicine Homeopathic Migraine Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955502821, NDC 57955-5028-2

Class I

Lot Numbers: 011617D Exp.

01/20; 030818M Exp. 03/20;

083116B Exp. 08/2019; 101217B

Exp. 10/19


King Bio Inc.

Drugs


Skin Irritations & Itch Relief, 2 fl. oz. (59 mL),

King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,

UPC 357955516828, NDC 57955-5168-2

Class I


01/20; 030916S Exp. 08/18;

041117K Exp. 04/19; 072216M

Exp. 07/19; 083115F Exp.

08/18


King Bio Inc.

Drugs


Colds & Flu Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955518228, NDC 57955-6182-2

Class I


01/19; 030916U Exp. 03/19;

121117D Exp. 12/19


King Bio Inc.

Drugs


Breakthrough for the Common Cold, 1 fl. oz.

(29.6 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC

28806, UPC 357955122111, NDC

57955-1221-1

Class I


03/20; 071718Z Exp. 07/20;

071818W Exp. 07/20; 071818X

Exp. 07/20; 071818Y Exp.

07/20; 071818Z Exp. 07/20


King Bio Inc.

Drugs Dr. King's Natural Class I Lot Numbers: Microbial King Bio



Product Type


Recall Recalling

Firm

Medicine Homeopathic Liver Detox, 2 fl. oz. (59


28806, UPC 357955006220, NDC

57955-5062-2

012616H Exp. 01/19; 031017C

Exp. 03/20; 052516AB Exp.

05/19; 083115G Exp. 08/18;

083116D Exp. 08/19; 010118R

Exp. 01/20

contamination Inc.

Drugs


Gallbladder Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,

NC 28806, UPC 357955506829, NDC

57955-6058-2

Class I


03/20; 040616E Exp. 04/19;

060216F Exp. 06/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Restless Leg Symptom Relief, 2 fl. oz. (59 mL),


UPC 357955544524, NDC 57955-6235-2

Class I


03/20; 042717C Exp. 04/20;

072815A Exp. 07/18; 092216C

Exp. 09/19; 120217E Exp.

12/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Scar Freee, 2 fl. oz. (59


28806, UPC 357955508724, NDC

57955-5087-2

Class I


03/19; 041817A Exp. 04/20;

050216H Exp. 05/19; 081117B

Exp. 08/19; 091015D Exp.

09/18


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Constipation Relief, 2 fl.


NC 28806, UPC 357955501923, NDC

57955-5019-2

Class I


03/20; 040616G Exp. 04/19;

072716B Exp. 07/19


King Bio Inc.


Medicine Homeopathic Class I

Lot Numbers: 022117E Exp.


King Bio Inc.



Product Type


Recall Recalling

Firm

Nuts & Seeds Intolerances, 2 fl. oz. (59


28806, UPC 357955520528, NDC

57955-5205-2

02/2020; 032216B Exp. 03/19;

072716E Exp. 07/2019

Drugs


Shellfish & Seafood Intolerances, 2 fl. oz. (59


28806, UPC 357955520122, NDC

57955-0726-2

Class I


03/19; 063016L Exp. 06/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Sinus Relief, 2 fl. oz. (59


28806, UPC 357955513421, NDC

57955-5134-2

Class I


03/20; 033116B Exp. 03/19;

041518F Exp. 04/20; 061715D

Exp. 06/18; 080116C Exp.

08/19; 100417A Exp. 10/19;

121916A Exp. 12/19


King Bio Inc.

Drugs


Ear Relief Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955515722, NDC 57955-0918-2

Class I


03/19; 101917B Exp. 10/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Outdoor Air Pollution

Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,

UPC 357955540427, NDC 57955-6104-2

Class I


03/2019; 071116R Exp. 02/2019


King Bio Inc.

Drugs Dr. King's Natural Class I Lot Numbers: Microbial King Bio



Product Type


Recall Recalling

Firm

Medicine Homeopathic EMF Detox, 2 fl. oz. (59


28806, UPC 357955597520, NDC

57955-5975-2

032816E Exp. 03/19; 033116M

Exp. 03/19; 062817A Exp.

06/19

contamination Inc.

Drugs

Dr. King's Natural Medicine Homeopathic 9-1-1 Burnout, 2 fl. oz. (59


28806, UPC 357955597926, NDC

57955-5979-2

Class I


03/19; 060816C Exp. 03/19;

082916A Exp. 08/19


King Bio Inc.

Drugs


Menopause Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955500629, NDC 57955-6006-2

Class I


03/19; 052516T Exp. 05/19;

080916D Exp. 08/2019; 090915B

Exp. 09/18; 110117F Exp.

11/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Appetite & Weight with

P.H.A.T., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,

UPC 357955515623, NDC 57955-5181-2

Class I


02/20; 112317C Exp. 11/19;

012616G Exp. 01/19; 033116A

Exp. 03/19; 052517F Exp.

05/20; 072916D Exp. 07/19;

091415H Exp. 09/18; 091616A

Exp. 09/19; 121916C Exp.

12/19


King Bio Inc.

Drugs


Lungs & Bronchial Relief, 2 fl. oz. (59 mL), King Bio,


Class I


02/20; 091415H Exp. 09/18;

012616G Exp. 01/19; 033116A


King Bio Inc.



Product Type


Recall Recalling

Firm

357955505327, NDC 57955-5053-2

Exp. 03/19; 072916D Exp.

07/19; 091616A Exp. 0919;

121916C Exp. 12/19; 052517F

Exp. 05/20; 112317C Exp.

11/19

Drugs


Anxiety & Nervousness, 2 fl. oz. (59 mL), King Bio,


357955516323, NDC 57955-5163-2

Class I


03/19; 042717D Exp. 04/20;

061616A Exp. 06/19; 072818A

Exp. 07/20; 081015D Exp.

08/18; 091516C Exp. 09/19;

112117F Exp. 11/19; 121516A

Exp. 12/19


King Bio Inc.

Drugs


Advanced Arnica, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955598428, NDC 57955-5984-2

Class I


01/20; 033116E Exp. 03/19;

080916H Exp. 08/19; 080917C Exp. 08/2019; 081015C Exp.

08/18


King Bio Inc.

Drugs


Back, Muscle & Joint Relief, 2 fl. oz. (59 mL),


UPC 357955516125, NDC 57955-6161-2

Class I

Lot Numbers: 012317H Exp.

01/20; 021418A Exp. 02/20;

033116F Exp. 03/19; 072216H

Exp. 07/19; 102717C Exp.

10/19


King Bio Inc.

Drugs


Arthritis Pain & Joint Relief, 2 fl. oz. (59 mL),

King Bio, Inc., 3 Westside

Class I


02/20; 033116G Exp. 03/19;

062316C 06/19;


King Bio Inc.



Product Type


Recall Recalling

Firm

Dr. Asheville, NC 28806, UPC 357955516224, NDC

57955-6162-2

080917D Exp. 08/19; 091616B

Exp. 09/19; 112117L Exp.

11/19

Drugs

Dr. King's Natural Medicine Homeopathic Yeast Freee, 2 fl. oz. (59


28806, UPC 357955507628, NDC

57955-5076-2

Class I


01/20; 033116J Exp. 03/19;

041017C Exp. 04/19; 072216G

Exp. 07/19


King Bio Inc.

Drugs


Urinary Tract Irritations, 2 fl. oz. (59 mL), King Bio,


357955505228, NDC 57955-5062-2

Class I


03/19; 060616A Exp. 06/19;

071316L Exp. 07/19; 080315G

Exp. 08/18; 111516D Exp.

11/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Animal Hair & Dander

Allergy Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955519621, NDC 57955-6490-2

Class I


01/19; 033116L Exp. 03/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Eye Stress, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955515128, NDC 57955-5151-2

Class I

Lot Numbers: 033116P Exp.

03/19; 110916B Exp. 11/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Hangover Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3


Class I


03/19; 083115C Exp. 08/18;

111516E Exp. 11/19


King Bio Inc.



Product Type


Recall Recalling

Firm

357955511328, NDC 57955-5113-2

Drugs


Weather Changes, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955528722, NDC 57955-5287-2

Class I

Lot Numbers: 033116R Exp.

03/19; 070816A Exp. 07/19


King Bio Inc.

Drugs


Eggs & Meats Intolerances, 2 fl. oz. (59


28806, UPC 357955522027, NDC

57955-0723-2

Class I

Lot Numbers: 033116S Exp.

03/19; 063016M Exp. 06/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Acne Clear, 2 fl. oz. (59


28806, UPC 357955504122, NDC

57955-5041-2

Class I


02/19; 033117C Exp. 03/20;

050216F Exp. 05/19; 072716D

Exp. 07/19; 091416J Exp.

09/19; 101017D Exp. 10/19


King Bio Inc.

Drugs


Mental Alertness for Seniors, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,

UPC 357955595625, NDC 57955-5956-2

Class I


02/19; 022317G Exp. 02/2020; 040115C Exp.

04/2018; 062416B Exp. 06/19;

112315D Exp. 11/2018


King Bio Inc.

Drugs


Indoor Air Pollution Detox, 2 fl. oz. (59 mL), King Bio,


357955540120, NDC

Class I


05/19; 063016J Exp. 06/19


King Bio Inc.



Product Type


Recall Recalling

Firm

57955-6001-2

Drugs


Anti-Aging & Wrinkles for Women, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,

UPC 357955814825, NDC 57955-8148-2

Class I


01/20; 020718A Exp. 02/20;

050216R Exp. 05/19; 081815H

Exp. 08/18; 101116C Exp.

10/19


King Bio Inc.

Drugs


Hemorrhoid Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955502326, NDC 57955-5023-2

Class I


01/20; 052516U Exp. 05/19;

050216S Exp. 05/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic PMS Relief, 2 fl. oz. (59


28806, UPC 357955500926, NDC

57955-5009-2

Class I


05/19; 080416C Exp. 08/19;

081815K Exp. 08/18


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Advanced First Aid, 2 fl.


NC 28806, UPC 357955511823, NDC

57955-6000-2

Class I


02/19; 050216K Exp. 05/19;

081315Q exp. 08/18


King Bio Inc.

Drugs


Muscle Maximizer, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955513322, NDC 57955-5133-2

Class I

Lot Numbers: 010118AE Exp. 01/20; 050216L Exp. 05/2019; 092216E Exp.

09/2019


King Bio Inc.


Medicine Homeopathic Asthma Symptom Relief, 2

Class I Lot Numbers: 022117B Exp.

02/20; 042417B


King Bio Inc.



Product Type


Recall Recalling

Firm

fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr.


57955-6044-2

Exp. 04/20; 050118M Exp.

05/20; 052516X Exp. 05/19;

062215B Exp. 06/18; 091015S

Exp. 09/18; 091416H Exp.

09/19; 101017E Exp. 10/19

Drugs


Artery, Cholesterol & BP, 2 fl. oz. (59 mL), King Bio,


357955506423, NDC 57955-5064-2

Class I


07/19; 071316K Exp. 05/19


King Bio Inc.

Drugs


Blood & Kidney Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,

NC 28806, UPC 357955506126, NDC

57955-5061-2

Class I


01/20; 050216D Exp. 05/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Bone Strengthener, 2 fl.


NC 28806, UPC 357955507029, NDC

57955-5070-2

Class I

Lot Numbers: 030118N Exp.

03/20; 042616A Exp. 04/19;

070516B Exp. 07/19; 070815B

Exp. 07/18; 101317H Exp.

10/19


King Bio Inc.

Drugs


Dairy Intolerances, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955519829, NDC 57955-6722-2

Class I


04/19; 062416A Exp. 06/19


King Bio Inc.





King Bio Inc.



Product Type


Recall Recalling

Firm

Hydration, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955024224, NDC 57955-0242-2

04/19; 070816E Exp. 07/19

Drugs


Allergy & Hay Fever Reliever, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,

UPC 357955504320, NDC 57955-5043-2

Class I


05/19; 052517D Exp. 05/20;

071316J Exp. 07/19; 082015D

Exp. 0818; 041618A Exp.

04/20; 101017F Exp. 10/19


King Bio Inc.

Drugs


Leg Cramp & Spasm Relief, 2 fl. oz. (59 mL), King Bio,


357955543527, NDC 57955-6035-2

Class I


04/20; 050516F Exp. 05/19;

101416A Exp. 10/19; 102816D

Exp. 10/19; 123115D Exp.

12/18


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Foul Bowel, 2 fl. oz. (59


28806, UPC 357955531920, NDC

57955-5319-2

Class I


04/19; 080216D Exp. 08/19;

081015S Exp. 08/18


King Bio Inc.

Drugs


Morning Sickness Relief, 2 fl. oz. (59 mL), King Bio,


357955500827, NDC 57955-6008-2

Class I


04/2019; 072716J Exp. 07/2019


King Bio Inc.

Drugs


Grains & Gluten Intolerances, 2 fl. oz. (59

Class I

Lot Numbers: 012517G Exp.

01/20; 040716A Exp. 04/19;


King Bio Inc.



Product Type


Recall Recalling

Firm


28806, UPC 357955520429, NDC

57955-0724-2

052516Z Exp. 05/19

Drugs


Water Retention, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955507826, NDC 57955-5078-2

Class I


01/19; 040616H Exp. 04/19;

073015B Exp. 07/18


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Breast Inflammations & Discomforts, 2 fl. oz. (59


28806, UPC 357955500322, NDC

57955-5003-2

Class I


04/19; 081016C Exp. 08/19;

010518K Exp. 01/20


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Wart Freee, 2 fl. oz. (59


28806, UPC 357955505921, NDC

57955-5059-2

Class I


01/20; 011416A Exp. 01/19;

072216J Exp. 07/19; 100417B

Exp. 10/19; 123115B Exp.

12/18


King Bio Inc.

Drugs


Varicose Veins, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955506621, NDC 57955-5566-2

Class I


03/19; 051716R Exp. 05/19;

073115G Exp. 07/18; 121216B

Exp. 12/19


King Bio Inc.

Drugs


Total Mold Allergy Relief, 2 fl. oz. (59 mL), King Bio,


Class I


02/19; 080916P Exp. 08/19;

081315M Exp. 08/18


King Bio Inc.



Product Type


Recall Recalling

Firm

357955519522, NDC 57955-6287-2

Drugs


Teeth & Gums Formula, 2 fl. oz. (59 mL), King Bio,


357955507321, NDC 57955-5073-2

Class I


01/20; 010518A Exp. 01/20;

022417C Exp. 02/20; 052516H

Exp. 05/19; 091616D Exp.

09/19; 112016A Exp. 11/19


King Bio Inc.

Drugs


Swollen Glands Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,

NC 28806, UPC 357955512127, NDC

57955-5121-2

Class I


03/19; 100815C Exp. 10/18


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Stye Relief, 2 fl. oz. (59

mL),King Bio, Inc., 3 Westside Dr. Asheville, NC

28806, UPC 357955512523, NDC

57955-5125-2

Class I


02/20; 052516AA Exp. 05/19;

091516E Exp. 09/19


King Bio Inc.

Drugs


Stress Control, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955507925, NDC 57955-5852-2

Class I


01/19; 020817E Exp. 02/20;

071818G Exp. 07/20; 111017C

Exp. 11/19


King Bio Inc.

Drugs


Sporting Edge, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955503125, NDC 57955-5031-2

Class I

Lot Numbers: 010118AF Exp.

01/20; 022916D Exp. 02/19


King Bio Inc.

Drugs Dr. King's Natural Class I Lots: 010118AH Microbial King Bio



Product Type


Recall Recalling

Firm

Medicine Homeopathic Sore Throat & Laryngitis, 2

fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr.


57955-5058-2

Exp. 01/20; 020916R Exp.

02/19; 022017B Exp. 02/20;

080415E Exp. 08/18; 090816F

Exp. 09/19

contamination Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Smoke Control, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955508021, NDC 57955-5080-2

Class I

Lots: 012017C Exp. 01/20; 022618B

Exp. 02/20; 063016A Exp.

06/19


King Bio Inc.

Drugs


Sleep Aid, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,

UPC 357955503927, NDC 57955-5839-2

Class I

Lots: 021016E Exp. 02/19; 060118C

Exp. 06/20; 060518A Exp.

06/20; 071318G Exp. 07/20;

080717A Exp. 08/19; 081315N

Exp. 08/18; 111516J Exp.

11/19; 122017A Exp. 12/2019; 122915D Exp.

12/18


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic ShinglePlex, 2 fl. oz. (59

mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 35795551829,

NDC 57955-5518-2

Class I

Lots: 081815L Exp. 08/18; 010118Q

Exp. 01/2020; 050216Z Exp.

05/19; 120616E Exp. 12/19


King Bio Inc.

Drugs


Sciatic Nerve Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,

NC 28806, UPC 357955503026, NDC

57955-6030-2

Class I

Lots: 012116B Exp. 01/19; 012317E

Exp. 01/20; 052516S Exp.

05/19; 071315A Exp. 07/18;

071818E Exp. 07/20; 080917B

Exp. 08/19;


King Bio Inc.



Product Type


Recall Recalling

Firm

091416F Exp. 09/19; 120217A

Exp. 12/19

Drugs


Paralixer, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,

UPC 357955501626, NDC 57955-5016-2

Class I

Lots: 010118Z Exp. 01/20; 012616D

Exp. 01/2019; 021717B Exp.

0919; 091216E Exp. 09/2019


King Bio Inc.

Drugs


No Sweat Anti-Perspirant, 2 fl. oz. (59 mL), King Bio,


357955508526, NDC 57955-5085-2

Class I Lots: 012616E Exp. 01/2019; 060716B

Exp. 06/19


King Bio Inc.

Drugs


Nausea & Motion Sickness, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,

UPC 357955505525, NDC 57955-5055-2

Class I

Lots: 020916P Exp. 02/19; 072216P

Exp. 07/19; 010518P Exp.

01/20


King Bio Inc.

Drugs


Multi-Strain Flu Relief, 2 fl. oz. (59 mL), King Bio, Inc. 3 Westside Dr. Asheville, NC

28806, UPC 357955519928, NDC

57955-5194-2

Class I

Lots: 013018A Exp. 01/2020; 020618B

Exp. 02/20; 072716H Exp.

07/19; 120617A Exp. 12/2019


King Bio Inc.

Drugs


Mental Calm, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955593027, NDC 57955-5930-2

Class I

Lots: 080916S Exp. 08/19; 021016F

Exp. 02/19; 062215J Exp.

06/18


King Bio Inc.


Medicine Homeopathic Mental Alertness, 2 fl. oz.

Class I Lots: 021016H

Exp.02/19; 061316A Exp.


King Bio Inc.



Product Type


Recall Recalling

Firm


28806, UPC 357955505426, NDC

57955-5954-2

06/2019

Drugs


Headache Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955515326, NDC 57955-5153-2

Class I Lots: 020718B Exp. 02/20; 091616M

Exp. 09/19


King Bio Inc.

Drugs


Head Colds Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955528227, NDC 57955-5382-2

Class I

Lots: 030216B Exp. 03/19; 051018A

Exp. 05/20; 091715D Exp.

09/18; 092815C Exp. 09/18


King Bio Inc.

Drugs


Hair & Nails Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,

NC 28806, UPC 357955504924, NDC

57955-5049-2

Class I Lots: 030216C Exp.

03/19; 080916G Exp. 08/19


King Bio Inc.

Drugs


Grief & Guilt Reliever, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,

NC 28806, UPC 357955503828, NDC

57955-5038-2

Class I

Lots: 022417G Exp. 02/20; 052516N

Exp. 05/19; 080416D Exp.

08/19


King Bio Inc.

Drugs


Gout Symptom Formula, 2 fl. oz. (59 mL), King Bio,


357955502128, NDC 57955-6021-2

Class I

Lots: 020118D Exp. 02/20; 071415A

Exp. 07/18; 080317C Exp.

08/2019


King Bio Inc.



Product Type


Recall Recalling

Firm

Drugs

Dr. King's Natural Medicine Homeopathic Fragrance & Phenolic

Allergy Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955520023, NDC 57955-6136-2

Class I

Lots: 012616F Exp. 01/19; 081315F

Exp. 08/18; 010418L Exp.

01/20


King Bio Inc.

Drugs


Food Intolerances, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955072720, NDC 57955-0727-2

Class I

Lots: 011216A Exp. 01/19; 030117Q

Exp. 03/20; 050216T Exp.

05/19; 060716H Exp. 06/19;

093016A Exp. 09/19


King Bio Inc.

Drugs


Food Chemical Intolerances, 2 fl. oz. (59


28806, UPC 357955504221, NDC

57955-0728-2

Class I

Lots: 120516A Exp. 12/19; 060316C

Exp. 06/19; 010118S Exp.

01/20


King Bio Inc.

Drugs


Fever Reliever, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955516026, NDC 57955-5160-2

Class I

Lots: 022417H Exp. 02/20; 030216D

Exp. 03/19; 052616J Exp.

05/19; 092815B Exp. 09/18


King Bio Inc.

Drugs


Female Libido, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955511526, NDC 57955-5515-2

Class I

Lots: 020618E Exp. 02/20; 080916U

Exp. 08/18; 102816C Exp.

10/19


King Bio Inc.


Medicine Homeopathic Dust Mite & Roach Allergy

Class I Lots: 020917L Exp.

02/20; 051116F Exp. 05/19;


King Bio Inc.



Product Type


Recall Recalling

Firm

Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806,

UPC 357955519720, NDC 57955-6497-2

100416A Exp. 10/19

Drugs

Dr. King's Natural Medicine Homeopathic Diarrhea Relief, 2 fl. oz. (59 mL), King Bio, Inc. 3


357955502029, NDC 57955-5020-2

Class I

Lots: 020916Q Exp. 02/19; 022117C

Exp. 02/20; 072015C Exp.

07/18; 081816D Exp. 08/19


King Bio Inc.

Drugs


Cough Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955516620, NDC 57955-5166-2

Class I Lots: 012516A Exp.

01/19; 090816D Exp. 09/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Cosmetic & Household Detox, 2 fl. oz. (59 mL),

King Bio, Inc. 3 Westside Dr. Asheville, NC 28806,

UPC 357955540328, NDC 57955-6103-2

Class I Lots: 021816B Exp.

02/19; 051216Q Exp. 05/19


King Bio Inc.

Drugs


Climate Adaptation Hot & Humid, 2 fl. oz. (59 mL),


UPC 357955528524, NDC 57955-0173-2

Class I

Lots: 022916C Exp. 02/19; 062415Y

Exp. 06/18; 071316B Exp.

07/19


King Bio Inc.

Drugs


Climate Adaptation Cold & Dry, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr.


57955-5283-2


02/19; 062415Z Exp. 06/18


King Bio Inc.



Product Type


Recall Recalling

Firm

Drugs


ClaustroPlex, 2 fl. oz. (59 mL), King Bio, Inc. 3


357955503521, NDC 57955-5035-2

Class I Lots: 021016J Exp. 02/19; 063016H

Exp. 06/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Bug Away, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955507727, NDC 57955-5077-2

Class I

Lots: 020116A Exp. 07/19; 050516B

Exp. 05/19; 071116B Exp.

07/19


King Bio Inc.

Drugs


Better Breath, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955880127

Class I Lots: 010118F Exp.

01/20; 051716E Exp. 05/19


King Bio Inc.

Drugs


Athlete's Foot Fighter, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,

NC 28806, UPC 357955512929, NDC

57955-5219-2

Class I

Lots: 020116B Exp. 02/19; 110116A

Exp. 02/19; 123016B Exp.

12/19


King Bio Inc.

Drugs


Anti-Aging & Wrinkles for Men, 2 fl. oz. (59 mL), King

Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC

357955814726, NDC 57955-8147-2


01/19; 072716G Exp. 07/19


King Bio Inc.

Drugs


CataClenz Eye Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,

NC 28806, UPC

Class I

Lots: 050216W Exp. 05/19;

080416B Exp. 08/19; 092216L

Exp. 09/19; 101217A Exp.


King Bio Inc.



Product Type


Recall Recalling

Firm

357955511229, NDC 57955-5112-2

10/19

Drugs


Adrenal Burnout, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955597926, NDC 57955-1434-2

Class I

Lots: 050218E Exp. 05/20; 080317E

Exp. 08/19; 120216A Exp.

12/19; 120217F Exp. 12/19


King Bio Inc.

Drugs


ChemoClenz, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955507123, NDC 57955-5071-2


05/19 Microbial

contamination King Bio

Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Fears & Phobias, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955515227, NDC 57955-5152-2

Class I Lots: 050916G Exp.

05/19; 120816L Exp. 12/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Dental Plak, 2 fl. oz. (59


28806, UPC 357955887027, NDC

57955-1904-2

Class I Lots: 051116E Exp.

05/19 Microbial


Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Additive & Preservative Detox, 2 fl. oz. (59 mL),

King Bio, Inc. 3 Westside Dr. Asheville, NC 28806,

UPC 357955540526, NDC 57955-6206-2


05/19; 072816A Exp. 07/19


King Bio Inc.


Medicine Homeopathic UlcerPlex Detox, 2 fl. oz.

Class I Lots: 051716D Exp.

05/19; 100316H Exp. 10/19


King Bio Inc.



Product Type


Recall Recalling

Firm


28806, UPC 357955507420, NDC

57955-5074-2

Drugs


Total Body Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955536123, NDC 57955-5361-2

Class I

Lots: 052516L Exp. 05/19; 083115D

Exp. 08/18; 091616Q Exp.

09/19; 110817A Exp. 11/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Ear Ringing, 2 fl. oz. (59


28806, UPC 357955527527, NDC

57955-5275-2

Class I Lots: 052516V Exp.

05/19; 052517E Exp. 05/20


King Bio Inc.

Drugs


Snore Control, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955512028, NDC 57955-5120-2

Class I

Lots: 052516Y Exp. 05/19; 060518C

Exp. 06/20; 060917F Exp.

06/19; 070518A Exp. 07/20;

080317C Exp. 08/19; 081015B

Exp. 08/18; 081815G Exp.

08/18; 111516C Exp. 11/19;

112317E Exp. 11/19


King Bio Inc.

Drugs


Fears & Nightmares, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,

NC 28806, UPC 357955509929, NDC

57955-5099-2

Class I

Lots: 052616F Exp. 05/19; 063015C

Exp. 06/18; 102816K Exp.

10/19


King Bio Inc.



Lots: 052616G Exp. 05/19; 080315C


King Bio Inc.



Product Type


Recall Recalling

Firm

Indigestion Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955502425, NDC 57955-5024-2

Exp. 08/18; 123016D Exp.

12/19

Drugs


Ileocecal Valve Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,

NC 28806, UPC 357955509820, NDC

57955-6083-2

Class I

Lots: 060116E Exp. 06/19; 083017F

Exp. 08/19; 101716E Exp.

10/19


King Bio Inc.

Drugs


TMJ/Jaw Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955503224, NDC 57955-5032-2

Class I

Lots: 060216C Exp. 06/19; 070815A

Exp. 07/18; 123016E Exp.

12/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Jet

Lag & Shift Change, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,

NC 28806, UPC 357955512622, NDC

57955-5126-2


06/19 Microbial


Inc.

Drugs


Constitutional Enhancer, 2 fl. oz. (59 mL), King Bio,


357955514923, NDC 57955-5149-2


06/19; 072315B Exp. 07/18


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Birth Ease, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955500223, NDC


06/19 Microbial


Inc.



Product Type


Recall Recalling

Firm

57955-5002-2

Drugs


Prostate Symptom Relief, 2 fl. oz. (59 mL), King Bio,


357955501121, NDC 57955-0241-2


06/19 Microbial


Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Acid Detox, 2 fl. oz. (59


28806, UPC 357955512721, NDC

57955-5227-2


06/19; 092216H Exp. 09/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Caffeine Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3


357955540229, NDC 57955-6202-2

Class I Lots: 062415T Exp.

06/18; 092716B Exp. 09/19


King Bio Inc.

Drugs


Climate Adaptation Hot & Dry, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr.


57955-0172-2

Class I Lots: 062415V Exp.

06/18 Microbial


Inc.

Drugs


Water Chemical Detox, 2 fl. oz. (59 mL), King Bio,


357955540021, NDC 57955-6100-2


06/19 Microbial


Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Mood Changes, 2 fl. oz. (59 mL), King Bio, Inc., 3


06/19 Microbial


Inc.



Product Type


Recall Recalling

Firm


357955503729, NDC 57955-5037-2

Drugs


Climate Adaptation Cold & Damp, 2 fl. oz. (59 mL),


UPC 357955528425, NDC 57955-0170-2


07/19 Microbial


Inc.

Drugs

Dr. King's Natural Medicine Homeopathic AddictaPlex, 2 fl. oz. (59


28806, UPC 357955508328, NDC

57955-5083-2


07/19; 081715G Exp. 08/18


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Odor Freee, 2 fl. oz. (59


28806, UPC 357955513025, NDC

57955-5130-2

Class I Lots: 102816H Exp. 10/2019; 123016D

Exp. 12/2019


King Bio Inc.

Drugs

Dr. King's Natural Medicine Homeopathic Heavy Metal Detox, 2 fl.


NC 28806, UPC 357955228127, NDC

57955-2281-2


12/19 Microbial


Inc.

Drugs

Dr. King's Kids Teething Homeopathic, 2 fl. oz. (59


28806, UPC 357955501824, NDC

57955-0527-2

Class I

Lots: 020118F Exp. 02/2020; 020717B

Exp. 02/2020; 080317D Exp.

08/2019; 110716C Exp. 11/2019; 111617E Exp.

11/2019


King Bio Inc.

Drugs Dr. King's Kids Bed Class I Lots: 101615B Exp. Microbial King Bio



Product Type


Recall Recalling

Firm

Wetting Homeopathic, 2 fl. oz. (59 mL), King Bio,

Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955501220, NDC

57955-0447-2

10/2018; 111717C Exp. 11/2019

contamination Inc.

Drugs

Dr. King's Aquaflora Kids Candida Relief

Homeopathic, 4 fl. oz. (118 mL), King Bio, Inc., 3

Westside Dr. Asheville, NC 28806 USA, UPC 357955332244

Class I

Lots: 011416G Exp. 12/2019; 011917R

Exp. 01/2020; 041518H Exp.

09/2018; 081016E Exp. 08/2019;

092815AA Exp. 09/2018


King Bio Inc.

Drugs

Dr. King's Natural Medicine Children's

Appetite Enhancer for kids! Homeopathic, 2 fl.


NC 28806 USA, UPC 357955531821, NDC

57955-5318-2

Class I

Lots: 020117F Exp. 02/2020; 060216E

Exp. 06/2019; 080916B Exp.

08/2019; 092415F Exp. 09/2018


King Bio Inc.

Drugs

Dr. King's Baby Colic Relief Homeopathic, 2 fl. oz. (59


28806 USA, UPC 357955515821, NDC

57955-0466-2

Class I Lots: 020118H Exp. 02/2020; 092017A

Exp. 09/2019


King Bio Inc.

Drugs

Dr. King's Natural Medicine for kids!

Children's Fever Reliever Homeopathic, 2 fl. oz. (59

mL), King Bio, Inc., 3 Westside dr. Asheville, NC

28806 USA, UPC 357955515920, NDC

57955-5159-2

Class I

Lots: 021216H Exp. 02/2019; 052616H

Exp. 05/2019; 102815C Exp.

10/2018; 120816A Exp. 12/2019


King Bio Inc.

Drugs


Children's Cough Relief Homeopathic, 2 fl. oz. (59


Class I

Lots: 021216J Exp. 02/2019; 030916T

Exp. 03/2019; 092815E Exp.

09/2018


King Bio Inc.



Product Type


Recall Recalling

Firm

28806 USA, UPC 357955514527, NDC

57955-6145-2

Drugs

Dr. King's Natural Medicine for kids! Chicken

Pox Symptom Relief Homeopathic, 2 fl. oz. (59


28806 USA, UPC 357955602521, NDC

57955-6025-2

Class I Lots: 021216K Exp. 02/2019; 062716D

Exp. 06/2019


King Bio Inc.

Drugs

Dr. King's Natural Medicine Kids Tummy

Aches Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville,

NC 28806 USA, UPC 357955514626, NDC

57955-4060-2

Class I

Lots: 021918B Exp. 02/2020; 050516D

Exp. 05/2019; 072216Q Exp.

07/2019


King Bio Inc.

Drugs


Attention & Learning Enhancement


Westside dr. Asheville, NC 28806 USA, UPC

357955501527, NDC 57955-5015-2

Class I

Lots: 050216G Exp. 05/2016; 070816C

Exp. 07/2019; 092617F Exp.

09/2019


King Bio Inc.

Drugs


Children's Ear Relief Formula Homeopathic, 2 fl. oz. (59 mL), King Bio,

Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955531524, NDC

57955-0416-2

Class I

Lots: 050216P Exp. 05/2019; 072516G

Exp. 07/2019; 112315B Exp.

11/2018


King Bio Inc.

Drugs

Dr. King's Natural Medicine for kids! Nosebleed Relief


Westside dr. Asheville, NC

Class I Lots: 050516H Exp. 05/2019; 080916J

Exp. 08/2019


King Bio Inc.



Product Type


Recall Recalling

Firm

28806 USA, UPC 357955514022, NDC

57955-5140-2

Drugs


Children's Growth & Development


Westside dr. Asheville, NC 28806 USA, UPC

357955514220, NDC 57955-5142-2

Class I Lots: 072516E Exp. 07/2019; 050516E

Exp. 05/2019


King Bio Inc.

Drugs

Dr. King's Natural Medicine Kids Stress &

Anxiety Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville,

NC 28806 USA, UPC 357955042327, NDC

57955-0423-2

Class I Lots: 070516E Exp. 07/2019; 081016G

Exp. 08/2019


King Bio Inc.

Drugs


Newborn Tonic Homeopathic, 2 fl. oz. (59


28806 USA, UPC 357955511427, NDC

57955-5114-2

Class I Lots: 063016K Exp. 06/2019; 112315F

Exp. 11/2018


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Bed Wetting Prevention

Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville,

NC 28806 USA, UPC 357955001225, NDC

57955-0012-2


08/2018 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Attention & Learning

Enhancement Children High Potency

Homeopathic Formula for

Class I

Lots: 032316C Exp. 03/2019; 091216A

Exp. 09/2019; 121617A Exp.

12/2019


King Bio Inc.



Product Type


Recall Recalling

Firm

Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville,

NC 28806 USA, UPC 357955001522, NDC

57955-0015-2

Drugs

Dr. King's SafeCare Rx Lower GI Restoration

Digestion High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville,

NC 28806 USA, UPC 357955032021, NDC

57955-0322-2

Class I

Lots: 030916J Exp. 03/19; 072516D

Exp. 07/19; 121717A Exp.

12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Influenza Multi-Strain Flu Medicine Immune High Potency Homeopathic

Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806

USA, UPC 357955019923, NDC 57955-0298-2

Class I

Lots: 011618A Exp. 01/20; 111617H

Exp. 11/19; 122216A Exp.

12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Lonely Mind & Body High

Potency Homeopathic Formula for Professional

Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806

USA, UPC 357955200024, NDC 57955-2001-2

Class I Lots: 010518H Exp.

01/20; 040616N Exp. 04/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Colic Relief Children High

Potency Homeopathic Formula for Professional

Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806

USA, UPC 357955015826, NDC 57955-0178-2


11/19 Microbial


Inc.

Drugs Dr. King's SafeCare Rx Class I Lots: 102016J Exp. Microbial King Bio



Product Type


Recall Recalling

Firm

Children's Appetite & Weight Control Children

High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,

NC 28806 USA, UPC 357955251729, NDC

57955-2518-2

10/19 contamination Inc.

Drugs

Dr. King's SafeCare Rx Tummy Aches Children


NC 28806 USA, UPC 357955014621, NDC

57955-0146-2


02/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Children's Growth &

Development Children High Potency

Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville,

NC 28806 USA, UPC 357955014225, NDC

57955-0148-2

Class I Lots: 020917A Exp. 02/2020; 062716E

Exp. 06/2019


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Children's Cough Children


NC 28806 USA, UPC 357955014522, NDC

57955-0145-2

Class I Lots: 091015B Exp. 09/2018; 120616B

Exp. 12/2019


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Newborn Tonic Children

High Potency Homeopathic Formula for


11/18 Microbial


Inc.



Product Type


Recall Recalling

Firm

Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville,

NC 28806 USA, UPC 357955011422, NDC

57955-0114-2

Drugs

Dr. King's SafeCare Rx Children's Ear Relief

Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,

NC 28806 USA, UPC 357955075721, NDC

57955-0758-2


03/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Chicken Pox Symptom

Relief Children High Potency Homeopathic

Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806

USA, UPC 357955782520, NDC 57955-7825-2


04/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Children's Fever Reliever

Children High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,

NC 28806 USA, UPC 357955015925, NDC

57955-0176-2

Class I Lots: 082516A Exp. 08/2019; 102015F

Exp. 10/2018


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Teething Children High Potency Homeopathic


USA, UPC 357955001829, NDC 57955-0018-2


03/19 Microbial


Inc.



Product Type


Recall Recalling

Firm

Drugs

Dr. King's SafeCare Rx Children's Appetite

Enhancer Children High Potency Homeopathic


USA, UPC 357955031826, NDC 57955-0318-2


02/19 Microbial


Inc.

Drugs

Dr. King's Natural Medicine Warming

Arthritic Pain & Joint Relief Homeopathic

Cream, Net Wt. 3 oz. (85 g), King Bio, Inc., 3

Westside Dr. Asheville, NC 28806 USA, UPC

357955093534, NDC 57955-0935-3

Class I

Lots: 020318ZZ Exp. 02/20;

051418ZZ Exp. 05/20; 060118ZZ

Exp. 06/20; 020418ZZ Exp.

02/20; 020518ZZ Exp. 02/20


King Bio Inc.

Drugs

Dr. King's Natural Medicine Rosacea

Symptom Relief Homeopathic Topical

Lotion, 3 oz. (85 g), King Bio, Inc., 3 Westside dr.


57955-0919-3

Class I

Lots: 021117ZZ Exp. 02/19;

031918ZZ Exp. 03/20; 110217ZZ

Exp. 09/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Psoriasis

Symptom Relief Homeopathic Topical

Lotion, 3 oz. (85 g), King Bio, Inc., 3 Westside Dr.


57955-0920-3

Class I

Lots: 013018ZZ Exp. 01/20;

021217ZZ Exp. 02/19; 110717ZZ

Exp. 11/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Eczema Symptom Relief

Homeopathic Topical Lotion, 3 oz. (85 g), King Bio, Inc., 3 Westside Dr.

Asheville, NC 28806 USA,

Class I

Lots: 010918ZZ Exp. 01/20;

021317ZZ Exp. 02/19; 090717ZZ

Exp. 09/19


King Bio Inc.



Product Type


Recall Recalling

Firm

UPC 357955092131, NDC 57955-0921-3

Drugs

Dr. King's Natural Medicine Cooling Acute

Pain Relief Pure Homeopathic Cream, 3 oz.

(85 g), King Bio, Inc., 3 Westside Dr. Asheville, NC

28806 USA, UPC 357955400134, NDC

57955-4001-3

Class I

Lots: 060816 Exp. 06/19; 081717ZZ

Exp. 08/19; 110117ZZ Exp.

11/20; 045017ZZ Exp. 04/20;

100516ZZ Exp. 06/19; 111016ZZ

Exp. 11/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Soothing Advanced Arnica Pure Homeopathic Cream

High Potency Homeopathic Formula for Professional Use Only, 3

oz. (85 g), King Bio, Inc., 3 Westside Drive Asheville,

NC 28806 USA, UPC 357955730132, NDC

57955-7301-3

Class I

Lots: 010517ZZ Exp. 01/20;

030818ZZ Exp. 03/21; 040617ZZ

Exp. 04/20; 100616ZZ Exp.

05/19; 110916ZZ Exp. 11/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Upper GI Restoration

Digestion High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc.,

3 Westside Drive Asheville, NC 28806 USA, UPC 357955032120, NDC

57955-0325-2

Class I

Lots: 051716U Exp. 05/19; 073115C

Exp. 07/18; 080216C Exp.

08/19; 120217N Exp. 12/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Soothing

Advanced Arnica Pure Homeopathic Cream, 3 oz.

(85 g), King Bio, Inc., 3 Westside Drive, Asheville,

NC 28806 USA, UPC 357955400035, NDC

57955-4000-3

Class I

Lots: 052616 Exp. 05/19; 073118ZZ

Exp. 07/21; 040117ZZ Exp.

06/19; 122717ZZ Exp. 12/20;

040417ZZ Exp. 04/20; 091617ZZ

Exp. 09/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies Plains U.S., 2 fl.

oz. (59 mL), King Bio, Inc., 3 Westside Drive,

Class I Lots: 010118E Exp. 01/20; 011917M

Exp. 01/20


King Bio Inc.



Product Type


Recall Recalling

Firm


57955-2720-2

Drugs

Dr. King's SafeCare Rx CS-Uterus Cancer Support, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,


57955-0247-2


09/19; 010118H Exp. 01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies Southern U.S.

Allergy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside

Drive, Asheville, NC 28806 USA, UPC 357955260127,

NDC 57955-2721-2

Class I

Lots: 050216AA Exp. 05/19;

101116B Exp. 10/19; 010118K

Exp. 01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Wart Freee..., 2 fl. oz. (59

mL), King Bio, Inc., 3 Westside Drive, Asheville,

NC 28806 USA, UPC 357955005926, NDC

57955-0360-2

Class I

Lots: 060816B Exp. 06/19; 012017D

Exp. 01/20; 010118N Exp.

01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Sugar Metabolizer

Men/Women, 2 fl. oz. (59 mL), King Bio, Inc., 3

Westside Drive, Asheville, NC 28806 USA, UPC 357955007227, NDC

57955-0365-2

Class I

Lots: 091015J Exp. 09/18; 060216A

Exp. 06/19; 091216H Exp.

09/19; 010118X Exp. 01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Lymph Detox Cleansing &

Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-0339-2

Class I

Lots: 080315A Exp. 08/18; 030916K

Exp. 03/19; 080916T Exp.

08/19; 020817G Exp. 02/20;

010118V Exp. 01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Intense Anxiety Mind & Body, 2 fl. oz. (59 mL),

King Bio, Inc., 3 Westside Drive, Asheville, NC 28806

Class I

Lots: 073015A Exp. 07/18; 123115F

Exp. 12/18; 060916A Exp.

06/19; 042717A


King Bio Inc.



Product Type


Recall Recalling

Firm

USA, UPC 357955175025, NDC 57955-1751-2

Exp. 04/20; 010118Y Exp.

01/20

Drugs

Dr. King's SafeCare Rx Allergies Southwest U.S., 2

fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,


57955-2715-2

Class I

Lots: 030818A Exp. 03/20; 011416B

Exp. 01/19; 111016B Exp.

11/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Skin Irritations & Itch Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,


57955-0177-2

Class I

Lots: 080916V Exp. 08/19; 010418C

Exp. 01/20; 022616G Exp.

02/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx UlcerPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-0188-2

Class I Lot: 010418D Exp.

01/20 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Stye Freee..., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-0132-2

Class I

Lots: 083115B Exp. 08/18; 061716A

Exp. 06/19; 120516B Exp.

12/19; 010418F Exp. 01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Fever Reliever Immune, 2



57955-0272-2

Class I Lot: 010518J Exp.

01/20 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Colds & Flu Immune, 2 fl. oz. (59 mL), King Bio, Inc.,

3 Westside Drive, Asheville, NC 28806 USA, UPC 357955038221, NDC

57955-0382-2

Class I

Lots: 063015F Exp. 06/18; 010616A

Exp. 01/19; 122216B Exp.

12/19; 022417J Exp. 02/20


King Bio Inc.

Drugs Dr. King's SafeCare Rx Stress Control Mind &


07/18; 010616C Microbial


Inc.



Product Type


Recall Recalling

Firm

Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-1852-2

Exp. 01/19; 021216G Exp.

02/19; 072516C Exp. 07/19;

101817A Exp. 10/19; 030818H

Exp. 03/20

Drugs

Dr. King's SafeCare Rx Anti-Aging & Wrinkles For Women, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-6148-2


03/19; 010617B Exp. 01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx ICV Clenz Cleansing & Detox, 2



57955-0262-2

Class I

Lots: 081015G Exp. 08/18; 030916B

Exp. 03/19; 012317B Exp.

01/20; 010818A Exp. 01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Blood & Kidney Detox

Cleansing & Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0190-2


07/19; 010818B Exp. 01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies: Shellfish &

Seafood Allergy, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-2201-2


08/18; 010918H Exp. 01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx M3 Metabolic Mineral

Modulator, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0277-2

Class I

Lots: 022216B Exp. 02/19; 062216S

Exp. 06/19; 011217B Exp.

01/20


King Bio Inc.



Product Type


Recall Recalling

Firm

Drugs

Dr. King's SafeCare Rx GallPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-0340-2


11/19; 011518B Exp. 01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Back, Neck, Muscle & Joint

Injuries, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-0261-2

Class I

Lots: 011518C Exp. 01/20; 081815J

Exp. 08/18; 032216F Exp.

03/19; 091616P Exp. 09/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies: Dust Mite &

Roach Allergy, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-2197-2


06/19; 011617B Exp. 01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Head Colds Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0282-2

Class I Lot: 011817B Exp.

01/20 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx SciatiPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-0030-2


01/20; 080315D Exp. 08/18


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Indecision Mind & Body, 2



57955-2771-2

Class I Lot: 011917L Exp.

01/20 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Aversion to Change Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside

Class I

Lots: 072015H Exp. 07/18; 111016F

Exp. 11/19; 011917N Exp.


King Bio Inc.



Product Type


Recall Recalling

Firm


NDC 57955-2800-2

01/20

Drugs

Dr. King's SafeCare Rx Wounds Recovery, 2 fl. oz.

(59 mL), King Bio, Inc., 3 Westside Drive, Asheville,

NC 28806 USA, UPC 357955011828, NDC

57955-0118-2

Class I

Lots: 081815M Exp. 08/18;

012017B Exp. 01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Asthma Clear Allergy, 2 fl. oz. (59 mL), King Bio, Inc.,


57955-0044-2

Class I Lots: 012116S Exp.

01/19; 122116A Exp. 12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx ScarCure, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-0087-2

Class I Lot: 012317A Exp.

01/20 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Paranoid Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,


57955-2261-2


04/19; 012317D Exp. 01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Aversion to Exertion Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-2790-2


06/18; 012517F Exp. 01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx SYP Miasm Constitution, 2 fl. oz. (59 mL), King Bio, Inc.,


57955-0306-2


01/20; 081015N Exp. 08/18


King Bio Inc.

Drugs Dr. King's SafeCare Rx Class I Lots: 012517J Exp. Microbial King Bio



Product Type


Recall Recalling

Firm

Anti-Aging & Wrinkles For Men, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955714729, NDC

57955-7148-2

01/20; 021616D Exp. 02/19;

051716V Exp. 05/19

contamination Inc.

Drugs

Dr. King's SafeCare Rx Repressed Sexual Issues

Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-1261-2


06/19; 012517K Exp. 01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx TUBR Miasm, 2 fl. oz. (59


NC 28806 USA, UPC 357955030423, NDC

57955-0304-2

Class I

Lots: 081815N Exp. 08/18; 080116D

Exp. 08/19; 012517L Exp.

01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies Animal Hair & Dander Allergy, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-2196-2

Class I Lot: 020117G Exp.

02/20 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Migraine Freee..., 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0028-2

Class I Lot: 020117H Exp.

02/20 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Sleep Aid, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-2640-2

Class I

Lots: 022318F Exp. 02/20; 020416A

Exp. 02/19; 080916N Exp.

08/19


King Bio Inc.

Drugs Dr. King's SafeCare Rx

Acute Viro Reliever, 2 fl. oz. (59 mL), King Bio, Inc.,


10/19; 072815F Exp. 07/18;


King Bio Inc.



Product Type


Recall Recalling

Firm


57955-0432-2

031016L Exp. 03/19; 020618A

Exp. 02/20

Drugs

Dr. King's SafeCare Rx LymePlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-0069-2

Class I

Lots: 072815F Exp. 07/18; 061716C

Exp. 06/19; 020817D Exp.

02/20; 030518F Exp. 03/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Better Breath Oral Health, 2 fl. oz. (59 mL), King Bio,

Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955630128, NDC

57955-6302-2


06/19; 020817F Exp. 02/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergy/Hay Fever Reliever

Allergy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-0043-2

Class I

Lots: 052616F Exp. 05/19; 020917B

Exp. 02/20; 030718D Exp.

03/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx TMJ/Jaw Formula Oral

Health, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-0032-2


07/18; 020917C Exp. 02/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Breast Cyst & Discomforts, 2 fl. oz. (59 mL), King Bio,


57955-0003-2


09/18; 010517B Exp. 01/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Heart Regularity

Circulation, 2 fl. oz. (59 mL), King Bio, Inc., 3


Class I

Lots: 083115F Exp. 08/18; 091516D

Exp. 09/19; 020917K Exp.

02/20


King Bio Inc.



Product Type


Recall Recalling

Firm

57955-0065-2

Drugs

Dr. King's SafeCare Rx ShinglePlex Skin, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-7501-2

Class I

Lots: 070815J Exp. 07/18; 091015G

Exp. 09/18; 021216F Exp.

02/19; 052616M Exp. 05/19;

083016A Exp. 08/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Snore Control Sleep, 2 fl. oz. (59 mL), King Bio, Inc.,


57955-0120-2


02/19; 083016B Exp. 08/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Alcoholism Mind & Body, 2 fl. oz. (59 mL), King Bio,


57955-3021-2


02/20 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Fears & Nightmares Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-1811-2


07/19; 022017C Exp. 02/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Cold Sores & Herpes Skin, 2 fl. oz. (59 mL), King Bio, Inc.,


57955-0165-2

Class I

Lots: 032216D Exp. 03/19; 072815G

Exp. 07/18; 022017A Exp.

02/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Sexual Identity Mind & Body, 2 fl. oz. (59 mL),

King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955127024,

NDC 57955-1271-2

Class I Lot: 021717C Exp.

02/20 Microbial


Inc.

Drugs Dr. King's SafeCare Rx Class I Lots: 080916F Exp. Microbial King Bio



Product Type


Recall Recalling

Firm

Male Strengthener, 2 fl. oz. (59 mL), King Bio, Inc.,


57955-0010-2

08/19; 062215C Exp. 06/18;

021616F Exp. 02/19

contamination Inc.

Drugs

Dr. King's SafeCare Rx Sluggish Mind Mind & Body, 2 fl. oz. (59 mL),


NDC 57955-1521-2


02/19; 111416A Exp. 11/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Adrenal Burnout Mind &

Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-0981-2

Class I

Lots: 021616C Exp. 02/19; 0711116P

Exp. 07/19; 102816J Exp.

10/19; 030117N Exp. 03/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Constitutional Enhancer Constitution, 2 fl. oz. (59


NC 28806 USA, UPC 357955014928, NDC

57955-0149-2

Class I

Lots: 102016F Exp. 10/19; 022316D

Exp. 02/19; 061716D Exp.

06/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Bone Strengthener, 2 fl.



57955-0070-2

Class I

Lots: 060316F Exp. 06/19; 022316B

Exp. 02/19; 122216H Exp.

12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Environmental Adaptation

Cold/Damp, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0284-2


02/19; 031517A Exp. 03/20


King Bio Inc.


Total Body Detox Class I

Lots: 022117K Exp. 02/20; 120316F


King Bio Inc.



Product Type


Recall Recalling

Firm

Cleansing & Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0361-2

Exp. 12/19; 040117B

Drugs

Dr. King's SafeCare Rx Chagrined, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-2041-2


06/19; 022117H Exp. 02/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Bladder Formula Urinary, 2 fl. oz. (59 mL), King Bio,


57955-0094-2

Class I

Lots: 072815K Exp. 07/18; 080916F

Exp. 08/19; 022117F Exp.

02/20; 052616P Exp. 05/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies Great Lakes U.S., 2 fl. oz. (59 mL), King Bio,


57955-2713-2

Class I

Lots: 060716F Exp. 06/19; 092216K

Exp. 09/19; 022018D Exp.

02/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Headache Freee... U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,

Asheville, NC 28806 USA, UPC 357955015321 NDC

57955-0153-2

Class I

Lots: 022516D Exp. 02/19; 080916A

Exp. 08/19; 121317K Exp.

12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx TremorPlex U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0033-2

Class I

Lots: 022516C Exp. 02/19; 072916F

Exp. 07/19; 030117C Exp.

03/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Chronic Viro Reliever U.S., 2 fl. oz. (59 mL), King Bio,

Inc., 3 Westside Drive,

Class I

Lots: 080916C Exp. 08/19; 022618A

Exp. 02/20; 072115F Exp.


King Bio Inc.



Product Type


Recall Recalling

Firm


57955-0103-2

07/18; 022516B Exp. 02/19;

052616N Exp. 05/19

Drugs

Dr. King's SafeCare Rx Aller-Detox: Water

Chemicals U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-3400-2


02/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Yeast Freee..., 2 fl. oz. (59


NC 28806 USA, UPC 357955007623, NDC

57955-0102-2


08/19; 022417B Exp. 02/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies: Mold, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-6501-2

Class I

Lots: 072015D Exp. 07/18; 022317F

Exp. 02/20; 123015B Exp.

12/18; 062816B Exp. 06/19;

091616B Exp. 09/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Arthritis & Joint Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,


57955-0162-2

Class I

Lots: 091015M Exp. 09/18;

022317D Exp. 02/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx ParaClenz, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0193-2

Class I

Lots: 081015J Exp. 08/18; 062816A

Exp. 06/19; 101716B Exp.

10/19; 030718A Exp. 03/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Nosebleed Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3

Westside Drive, Asheville,

Class I Lots: 051716K Exp.

05/19; 030317A Exp. 03/20


King Bio Inc.



Product Type


Recall Recalling

Firm

NC 28806 USA, UPC 357955014027, NDC

57955-0140-2

Drugs

Dr. King's SafeCare Rx Candida, 8 fl. oz. (236 mL), King Bio, Inc., 3 Westside


NDC 57955-6207-8

Class I

Lots: 050216AB Exp. 05/19;

071416A Exp. 07/19; 101716C

Exp. 10/19; 030117F Exp.

03/20; 120217C Exp. 12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx PMS Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0095-2


08/19; 022916E Exp. 02/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx CS-Rectal Bowel, 2 fl. oz. (59


NC 28806 USA, UPC 357955021827, NDC

57955-0218-2

Class I

Lots: 022616F Exp. 02/19; 080217A

Exp. 08/19; 060716K Exp.

06/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx CS-Brain, 2 fl. oz. (59 mL),


NDC 57955-0222-2


02/19; 122216E Exp. 12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx CS-Skin, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955021926, NDC

57955-0224-2


12/18; 022616B Exp. 02/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx CS-Bone, 2 fl. oz. (59 mL),


NDC 57955-0211-2


01/20 Microbial


Inc.

Drugs Dr. King's SafeCare Rx CS-Breast, 2 fl. oz. (59 mL),


09/18; 010517B Microbial


Inc.



Product Type


Recall Recalling

Firm


NDC 57955-0214-2

Exp. 01/20

Drugs

Dr. King's SafeCare Rx Sore Throat & Laryngitis, 2



57955-0137-2

Class I

Lots: 072815M Exp. 07/18;

031016K Exp. 03/19; 030718H

Exp. 03/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Hypochondria, 2 fl. oz. (59


NC 28806 USA, UPC 357955180029, NDC

57955-1807-2


03/19; 103116A Exp. 10/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Self-Pity, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955253020, NDC

57955-2532-2


03/19; 081916B Exp. 08/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Gossipy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-2251-2

Class I Lot: 031016F Exp.

03/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Good Mood Enhancer, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,


57955-2080-2

Class I

Lots: 050317A Exp. 05/20; 072815S

Exp. 07/18; 031016F Exp.

03/19; 071116G Exp. 07/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Urinary Tract Infections, 2



57955-0052-2

Class I

Lots: 072815J Exp. 07/18; 030916Y

Exp. 03/19; 110716B Exp.

11/19; 101317J Exp. 10/19


King Bio Inc.

Drugs Dr. King's SafeCare Rx Class I Lots: 030916N Exp. Microbial King Bio



Product Type


Recall Recalling

Firm

Aller-Detox: Food Addititives &

Preservatives, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-2405-2

03/19; 121217A Exp. 12/19

contamination Inc.

Drugs

Dr. King's SafeCare Rx CA Miasm, 2 fl. oz. (59 mL),


NDC 57955-0300-2


03/19; 121216D Exp. 12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Fear & Phobia, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside

Drive, Asheville, NC 28806 USA, UPC

357955179023,NDC 57955-1791-2

Class I

Lots: 072015E Exp. 07/18; 032216G

Exp. 03/19; 102816E Exp.

10/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Gout Symptom Relief, 2 fl. oz. (59 mL), King Bio, Inc.,


57955-0021-2


09/19; 032216F Exp. 03/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Heavy Metal Detox, 2 fl.



57955-0281-2

Class I

Lots: 090816H Exp. 09/19; 072815D

Exp. 07/18; 031017J Exp.

03/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Perfectionism, 2 fl. oz. (59

mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, NDC UPC

357955184027, NDC 57955-1841-2


04/20; 031016J Exp. 03/19


King Bio Inc.


Eating Disorders, 2 fl. oz. (59 mL), King Bio, Inc., 3


04/19 Microbial


Inc.



Product Type


Recall Recalling

Firm


57955-0001-2

Drugs

Dr. King's SafeCare Rx Easily Angered, 2 fl. oz. (59


NC 28806 USA, UPC 357955102021, NDC

57955-1021-2


04/20 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Constipation Relief, 2 fl.



57955-0019-2

Class I

Lots: 072815L Exp. 07/18; 041416L

Exp. 04/19; 082916B Exp.

08/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Artery/Cholesterol/BP, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,


57955-0064-2


09/18; 041416F Exp. 04/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Heartburn Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0022-2


04/19; 091416K Exp. 09/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Bactero Reliever, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0117-2

Class I

Lots: 092915F Exp. 09/18; 081616B

Exp. 08/19; 041416A Exp.

04/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Envious, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-2523-2


04/20 Microbial


Inc.



Product Type


Recall Recalling

Firm

Drugs

Dr. King's SafeCare Rx Extravagant, 2 fl. oz. (59


NC 28806 USA, UPC 357955233022, NDC

57955-2331-2

Class I Lot: 040616O Exp.

04/19 Microbial


Inc.

Drugs

SafeCareRx Nostalgia, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,

NC 28806 USA, UPC 357955278023, NDC

57955-2781-2

Class I Lot: 040616M Exp.

04/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Grief, 2 fl. oz. (59 mL),


NDC 57955-2061-2

Class I

Lots: 062415M Exp. 06/18;

040616P Exp. 04/19; 102016K

Exp. 10/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies Desert U.S., 2 fl. oz. (59 mL), King Bio, Inc.,


57955-2704-2


04/20; 031417B Exp. 03/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Appetite & Weight with

P.H.A.T., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-2181-2

Class I

Lots: 072915A Exp. 07/18; 121217B

Exp. 12/19; 071116Q Exp.

07/19; 102816F Exp. 10/19;

033117B Exp. 03/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Expressed Sexual Issues, 2



57955-1257-2


05/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Bug Away, 2 fl. oz. (59 mL),

King Bio, Inc., 3 Westside Drive, Asheville, NC 28806

Class I

Lots: 072215C Exp. 07/18; 070516C

Exp. 07/19; 050516C Exp.


King Bio Inc.



Product Type


Recall Recalling

Firm

USA, UPC 357955007722, NDC 57955-0077-2

05/19

Drugs

Dr. King's SafeCare Rx Mood Changes, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-2021-2

Class I Lots: 051216N Exp.

05/19; 120816M Exp. 12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Indigestion Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0024-2


04/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx VeinoPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0066-2

Class I

Lots: 062415H Exp. 06/18; 111516P

Exp. 11/19; 062016D Exp.

06/19; 040717D Exp. 04/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Advanced Arnica, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-7304-2

Class I

Lots: 040118A Exp. 04/20; 060616C

Exp. 06/19; 110117F Exp.

11/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Lungs & Bronchial Relief, 2



57955-0053-2

Class I

Lots: 070816B Exp. 07/19; 080917A

Exp. 08/19; 050216N Exp.

05/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Insecurity, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-2561-2


04/19; 072216N Exp. 07/19


King Bio Inc.

Drugs Dr. King's SafeCare Rx Class I Lots: 102116A Exp. Microbial King Bio



Product Type


Recall Recalling

Firm

Cough Control, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0166-2

10/19; 063015D Exp. 06/18;

123115E Exp. 12/18; 051716L

Exp. 05/19; 022117L Exp.

02/20

contamination Inc.

Drugs

Dr. King's SafeCare Rx Leg Cramps & Spasms, 2 fl. oz.


NC 28806 USA, UPC 357955043522, NDC

57955-0435-2

Class I

Lots: 072015J Exp. 07/18; 051716H

Exp. 05/19; 081016B Exp.

08/19; 092617B Exp. 10/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies Northest U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,


57955-2707-2

Class I

Lots: 051716G Exp. 05/19; 072516H

Exp. 07/19; 081117C Exp.

08/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Personality Changes, 2 fl. oz. (59 mL), King Bio, Inc.,


57955-1053-2


05/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Reserved, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-2282-2

Class I Lot: 051216P Exp.

05/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Dental Plak, 2 fl. oz. (59


NC 28806 USA, UPC 357955008620, NDC

57955-0086-2


05/19; 110916C Exp. 11/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx VaccinoClenz, 2 fl. oz. (59


Class I

Lots: 081015F Exp. 08/18; 050216Y

Exp. 05/19; 090116C Exp.


King Bio Inc.



Product Type


Recall Recalling

Firm

NC 28806 USA, UPC 357955003224, NDC

57955-0082-2

09/19

Drugs

Dr. King's SafeCare Rx Calcium Metabolizer, 2 fl. oz. (59 mL), King Bio, Inc.,


57955-0131-2

Class I

Lots: 071316F Exp. 07/19; 120816B

Exp. 12/19; 050216AD Exp.

05/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies: Grains & Gluten, 2 fl. oz. (59 mL), King Bio,


57955-2203-2


11/19; 041416E Exp. 04/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Immature, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-2291-2


06/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Morning Sickness, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0008-2


06/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Eye Stress, 2 fl. oz. (59 mL),


NDC 57955-0151-2


06/19; 121317F Exp. 12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Obsessions/Compulsions, 2 fl. oz. (59 mL), King Bio,


57955-1831-2


06/19; 020917F Exp. 02/20


King Bio Inc.

Drugs Dr. King's SafeCare Rx Class I Lot: 052616/f Exp. Microbial King Bio



Product Type


Recall Recalling

Firm

Complaining, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-2301-2


Drugs

Dr. King's SafeCare Rx Menstrual Cramps &

Irregularities, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0004-2


08/19; 052616D Exp. 05/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Bio Reset/Jet Lag, 2 fl. oz. (59


NC 28806 USA, UPC 357955012627, NDC

57955-0126-2

Class I

Lots: 022316C Exp. 02/19; 052516Q

Exp. 05/19; 102016E Exp.

10/19; 112117G Exp. 11/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Hemorrhoid Relief, 2 fl. oz.


NC 28806 USA, UPC 357955002321, NDC

57955-0023-2

Class I Lots: 052516P Exp.

05/19; 091316B Exp. 09/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Spaced Out, 2 fl. oz. (59


NC 28806 USA, UPC 357955154020, NDC

57955-1541-2


05/19; 121317E Exp. 12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Restless Leg Syndrome, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,


57955-0445-2

Class I Lots: 051716X Exp.

05/19; 101116A Exp. 10/19


King Bio Inc.


Female Enhancer, 2 fl. oz. (59 mL), King Bio, Inc., 3


06/19; 120116A Exp. 12/19


King Bio Inc.



Product Type


Recall Recalling

Firm


57955-0115-2

Drugs

Dr. King's SafeCare Rx Aller-Detox: Herbicides &

Pesticides, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-2406-2


07/18; 060216B Exp. 06/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies: Dairy, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-2198-2

Class I

Lots: 073115B Exp. 07/18; 062116B

Exp. 06/19; 121216C Exp.

12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies: Nuts & Seeds, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,


57955-2204-2

Class I

Lots: 082815A Exp. 08/18; 112117D

Exp. 11/19; 061416A Exp.

06/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies: Food Chemicals U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955004226, NDC

57955-0042-2

Class I

Lots: 062415X Exp. 06/18; 052815G

Exp. 05/18; 051716T Exp.

05/19; 092216J Exp. 09/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Odor Freee..., 2 fl. oz. (59


NC 28806 USA, UPC 357955013020, NDC

57955-0130-2


05/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Acid Clenz, 2 fl. oz. (59 mL),


Class I Lots: 050216U Exp.

05/19; 072716C Exp. 07/19


King Bio Inc.



Product Type


Recall Recalling

Firm

NDC 57955-0127-2

Drugs

Dr. King's SafeCare Rx Calloused, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-2311-2


06/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Religious Issues, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-2541-2

Class I Lot: 063016B Exp.

06/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Hair & Nails Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0049-2

Class I

Lots: 072015F Exp. 07/18; 062816E

Exp. 06/19; 100316E Exp.

10/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx CS-General Support, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0213-2

Class I

Lots: 062716A Exp. 06/19; 091616H

Exp. 09/19; 122217M Exp.

12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx FertiCare, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-0005-2

Class I Lot: 062615E Exp.

06/18 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Prejudiced, 2 fl. oz. (59


NC 28806 USA, UPC 357955100027, NDC

57955-2322-2


Unknown Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Hydration, 2 fl. oz. (59 mL), King Bio, Inc., 3

Westside Drive, Asheville,

Class I

Lots: 062615B Exp. 06/18; 121916D

Exp. 12/19; 092617E Exp.


King Bio Inc.



Product Type


Recall Recalling

Firm

NC 28806 USA, UPC 357955010029, NDC

57955-0100-2

09/19

Drugs

Dr. King's SafeCare Rx AddictaPlex, 2 fl. oz. (59


NC 28806 USA, UPC 357955300021, NDC

57955-3003-2

Class I Lot: 062415R Exp.

06/18 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Swollen Glands Relief, 2 fl. oz. (59 mL), King Bio, Inc.,


57955-0121-2

Class I

Lots: 081315L Exp. 08/18; 062415K

Exp. 06/18; 120816F Exp.

12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Teeth & Gum Formula, 2

fl. oz. (59 mL), NDC 57955-0073-2 UPC

357955007326 King Bio, Inc., 3 Westside Drive,

Asheville, NC 28806 USA

Class I

Lots: 062415E Exp. 06/18; 071116D

Exp. 07/18; 121317H Exp.

12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Stubborn & Contentious, 2



57955-1031-2

Class I

Lots: 062316A Exp. 06/19; 101716D

Exp. 10/19; 122216D Exp.

12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Ear Relief Formula, 2 fl. oz. (59


NC 28806 USA, UPC 357955015727, NDC

57955-0154-2


06/18; 091316A Exp. 09/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx First Aid for Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc.,


57955-1770-2

Class I

Lots: 072815Q Exp. 07/18; 081815E

Exp. 08/18; 091216F Exp.

09/19; 071317A Exp. 07/19


King Bio Inc.



Product Type


Recall Recalling

Firm

Drugs

Dr. King's SafeCare Rx Nausea & Motion

Sickness, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-0055-2

Class I

Lots: 072815T Exp. 07/18; 071116F

Exp. 07/19; 122216F Exp.

12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies: Eggs & Meats, 2



57955-2207-2

Class I

Lots: 081715D Exp. 08/18; 071116E

Exp. 07/19; 091616E Exp.

09/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Tinnitus Relief, 2 fl. oz. (59


NC 28806 USA, UPC 357955027522, NDC

57955-0275-2

Class I

Lots: 111417D Exp. 11/19; 070815D

Exp. 07/18; 090816J Exp.

09/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Gambling, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-3011-2

Class I Lot: 063016G Exp.

06/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx No Sweat/Anti-Perspirant, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,


57955-0085-2


06/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Self-Abuse, 2 fl. oz. (59 mL),


NDC 57955-1071-2

Class I Lots: 072815P Exp.

07/18; 111016D Exp. 11/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Heartache, 2 fl. oz. (59


NC 28806 USA, UPC


08/18; 072516F Exp. 07/19


King Bio Inc.



Product Type


Recall Recalling

Firm

357955203025, NDC 57955-2030-2

Drugs

Dr. King's SafeCare Rx CS-Pain Reliever, 2 fl. oz. (59


NC 28806 USA, UPC 357955021728, NDC

57955-0217-2


07/19; 122216C Exp. 12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx ChemoClenz, 2 fl. oz. (59


NC 28806 USA, UPC 357955007128, NDC

57955-0071-2


06/18; 080916X Exp. 08/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Diarrhea Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0020-2


07/18; 081816A Exp. 08/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Menopause Relief, 2 fl. oz.


NC 28806 USA, UPC 357955000624, NDC

57955-0006-2

Class I Lots: 072815C Exp. 07/18; 092216M

Exp. 09/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies: Fragrances &

Phenolics, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-2205-2


07/18; 122116B Exp. 12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Environmental

Adaptation: Weather Changes, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-0287-2

Class I

Lots: 072516M Exp. 07/19;

082615B Exp. 08/18


King Bio Inc.



Product Type


Recall Recalling

Firm

Drugs

Dr. King's SafeCare Rx Allergy & Red Eye Relief, 2



57955-0164-2


07/19; 080315B Exp. 08/18


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Criticize & Contradict, 2 fl. oz. (59 mL), King Bio, Inc.,


57955-1081-2


08/18 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx CS-Lymph Hodgkins, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0215-2


08/18; 121916B Exp. 12/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Liver Detox, 2 fl. oz. (59


NC 28806 USA, UPC 357955006220, NDC

57955-0062-2

Class I

Lots: 073115F Exp. 07/18; 030916M

Exp. 03/19; 080916W Exp.

08/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies Rocky Mtns. U.S., 2 fl. oz. (59 mL), King Bio,


57955-0062-2


07/18 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx CataCure, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-0112-2

Class I Lots: 072815Y Exp.

07/18; 080916L Exp. 08/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Mental Alertness For

Seniors, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside

Class I Lots: 072815R Exp.

07/18; 090116D Exp. 09/19


King Bio Inc.



Product Type


Recall Recalling

Firm


NDC 57955-1561-2

Drugs

Dr. King's SafeCare Rx Environmental Adaptation Cold/Dry, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-0288-2


06/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Environmental Adaptation

Hot/Humid, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0285-2

Class I

Lots; 081015K Exp. 08/18; 071316H

Exp. 07/19; 111716J Exp.

11/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Aller-Detox: Indoor

Pollution Control, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-2408-2


08/18 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx ApoPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside


NDC 57955-0067-2


08/18; 091616J Exp. 09/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Muscle Maximizer, 2 fl. oz.


NC 28806 USA, UPC 357955013327, NDC

57955-0133-2


08/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Acne Clear, 2 fl. oz. (59


NC 28806 USA, UPC 357955004127, NDC


09/19; 081617A Exp. 08/19


King Bio Inc.



Product Type


Recall Recalling

Firm

57955-0041-2

Drugs

Dr. King's SafeCare Rx Aller-Detox: Cosmetics & Household, 2 fl. oz. (59


NC 28806 USA, UPC 357955240327, NDC

57955-2407-2


08/18 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Water Retention Control, 2 fl. oz. (59 mL), King Bio,


57955-0278-2


08/18 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Birth Ease, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0002-2


09/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Hangover Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-0113-2


08/18; 091416E Exp. 09/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Appetite Enhancer, 2 fl.



57955-0128-2

Class I

Lots: 091015C Exp. 09/18; 082516B

Exp. 08/19; 022317F Exp.

02/20


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies: Nightshades, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,


57955-2502-2


08/19 Microbial


Inc.

Drugs Dr. King's SafeCare Rx Class I Lots: 082316B Exp. Microbial King Bio



Product Type


Recall Recalling

Firm

Verbal Anger, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-1061-2

08/19; 100115D Exp. 10/18

contamination Inc.

Drugs

Dr. King's SafeCare Rx Shy, 2 fl. oz. (59 mL), King Bio,


57955-2751-2


09/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Restless Mind, 2 fl. oz. (59


NC 28806 USA, UPC 357955153023, NDC

57955-1531-2

Class I

Lots: 091415A Exp. 09/18; 113015K

Exp. 11/18; 122915A Exp.

12/18


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Procrastination, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-2761-2


09/18; 091316C Exp. 09/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Allergies: Fruits &

Vegetables, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-2501-2


11/19; 091216B Exp. 09/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Smoke Control, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-3031-2


09/18; 111716H Exp. 11/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx GynePlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside

Drive, Asheville, NC 28806


09/18; 100416C Exp. 10/19


King Bio Inc.



Product Type


Recall Recalling

Firm

USA, UPC 357955000723, NDC 57955-0007-2

Drugs

Dr. King's SafeCare Rx Physical Anger, 2 fl. oz. (59


NC 28806 USA, UPC 357955101024, NDC

57955-1011-2


11/19; 091015E Exp. 09/18


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Sporting Edge, 2 fl. oz. (59


NC 28806 USA, UPC 35795500312, NDC

57955-0031-2


12/18; 101716A Exp. 10/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Poison Ivy & Oak Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,


57955-0116-2


09/18; 092216F Exp. 09/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx EMF Detox, 2 fl. oz. (59 mL),


NDC 57955-0420-2


11/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Overly-Sensitive, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-2071-2


11/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Neglectful, 2 fl. oz. (59


NC 28806 USA, UPC 357955255024, NDC

57955-2551-2


11/19 Microbial


Inc.

Drugs Dr. King's SafeCare Rx CS-Stomach, 2 fl. oz. (59 mL),


11/19 Microbial


Inc.



Product Type


Recall Recalling

Firm


NDC 57955-0220-2

Drugs

Dr. King's SafeCare Rx PSOR Miasm, 2 fl. oz. (59


NC 28806 USA, UPC 357955030126, NDC

57955-0307-2


12/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Foul Bowel, 2 fl. oz. (59 mL),


NDC 57955-0319-2


11/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Claustrophobia, 2 fl. oz. (59 mL), King Bio, Inc., 3


57955-1822-2


12/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Athlete's Foot Fighter, 2 fl. oz. (59 mL), King Bio, Inc.,


57955-0129-2


12/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx CS-Ovary, 2 fl. oz. (59 mL),


NDC 57955-0216-2


12/18; 122216J Exp. 12/19


King Bio Inc.

Drugs

People's Best Arnica Gel Homeopathic Medicine

Pain Relief, Net Wt. 2.6 oz (73 g), www.kingbio.com, UPC 357955320326, NDC

57955-3203-3

Class I

Lots: 111617ZZ Exp. 11/19;

072016ZZ Exp. 07/18; 092316ZZ

Exp. 09/18


King Bio Inc.

Drugs Aquaflora High Potency

Candida Control Program Class I

Lots: 011017A Exp. 01/20; 033116T


King Bio Inc.



Product Type


Recall Recalling

Firm

Homeopathic Formula, Net 16 fl. oz. (1 pt) 473 mL, Manufactured by:

King Bio, Inc. 3 Westside Dr. Asheville, NC 28806

USA, UPC 357955160366, NDC 57955-1603-6

Exp. 03/19; 052516R Exp.

05/19; 122815A Exp. 12/18

Drugs

Aquaflora Phase II Candida Control Program,

Net 16 fl. oz. (1 PT) 473 mL, Homeopathic

Formula, Manufactured by: King Bio, Inc. 3


357955160267, NDC 57955-1602-6

Class I

Lots: 010518G Exp. 07/18; 011617F

Exp. 01/20; 021016G Exp.

02/19; 051716P Exp. 02/19;

072315A Exp. 07/18


King Bio Inc.

Drugs

Aquaflora Phase I Candida Control Program, Net 16

fl. oz. (1 PT) 473 mL, Homeopathic Formula, Manufactured by: King Bio, Inc. 3 Westside Dr.


57955-1601-6

Class I

Lots: 022218D Exp. 02/20; 100917D

Exp. 10/19; 021717A Exp.

02/20; 041816B Exp. 04/19;

062816F Exp. 06/19; 122815B

Exp. 12/18


King Bio Inc.

Drugs

Dr. King's Aquaflora Enzyme Restoration

Upper GI Homeopathic, 2 fl. oz. (59 mL), King Bio,

Inc. 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955232124, NDC

57955-3321-2

Class I

Lots: 102016H Exp. 10/19; 010518E

Exp. 01/20; 050616A Exp.

05/19


King Bio Inc.

Drugs

Aquaflora Heavy Metal Detox Candida, 2 fl. oz. (59

mL), Homeopathic, King Bio, Inc. 3 Westside Dr.

Asheville, NC 28806 USA, NDC 57955-2281-2


08/19 Microbial


Inc.

Drugs

Dr. King's Aquaflora Probiotic Restoration

Lower GI Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,

Class I

Lots: 020618D Exp. 02/20; 030916P

Exp. 03/19; 041215I Exp.

04/18; 072216L


King Bio Inc.



Product Type


Recall Recalling

Firm


57955-3320-2

Exp. 07/19

Drugs

Safecare+ Southeast Regional Allergies

Homeopathic Non-Drowsy Taste Free, Oral Spray, 1 fl

oz (29.6 mL), UPC 357955834519, NDC

57955-8345-1


01/20; 080515A Exp. 08/18


King Bio Inc.

Drugs

Safecare+ AllergyCare Homeopathic Non-Drowsy Taste-Free, Oral Spray, 1 fl

oz (29.6 mL), UPC 357955404316, NDC

57955-4043-1


02/20; 091015R Exp. 09/18


King Bio Inc.

Drugs

Safecare+ AsthmaCare Homeopathic, Not a

Rescue Inhaler, 1 fl oz (29.6 mL), UPC

357955704416, NDC 57955-7044-1

Class I

Lots: 030316B Exp. 03/19; 061715A

Exp. 06/18; 061715B Exp.

06/18


King Bio Inc.

Drugs

Dr. King's Safecare+ AsthmaCare

Homeopathic, Not a Rescue Inhaler, 2 fl oz (59 mL), UPC 357955404422,

NDC 57955-4044-1

Class I

Lots: 122216K Exp. 12/19; 120217P

Exp. 12/19; 111117C Exp.

11/19; 083116C Exp. 08/19;

082316E Exp. 08/19; 072015A

Exp. 07/18; 062716C Exp.

06/19; 062316B Exp. 06/19;

062218C Exp. 06/20; 052218C

Exp. 05/20; 052118C Exp.

05/20; 051716J Exp. 05/19;

041816C Exp. 04/19; 030316A

Exp. 03/19; 022317H Exp.

02/20; 111516H


King Bio Inc.



Product Type


Recall Recalling

Firm

Exp. 11/19; 091815A Exp.

09/18; 062718C Exp. 06/20;

081815A Exp. 08/18

Drugs

Safecare+ Northeast Regional Allergies Non-Drowsy Homeopathic

Taste-Free, Oral Spray, 1 fl oz (29.6 mL), UPC

357955832515, NDC 57955-8325-1


07/18 Microbial


Inc.

Drugs

NET Remedies #1 Homeopathic Preparation,

Oral Liquid, 57 mL, Manufacturer: King Bio

Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428

Hume Street, Toowoomba QLD 4350, Australia

Class I

Lots: AUS-091515A Exp. 09/18; AUS-

081516H Exp. 08/19; AUS-

050516A Exp. 05/19; AUS-

030816A Exp. 03/19; AUS-

011117A Exp. 01/20; AUS-

011916A Exp. 01/19


King Bio Inc.

Drugs





Class I


062317B Exp. 06/20; AUS-

061016C Exp. 06/19; AUS-

030816K Exp. 03/19; AUS-

011916K Exp. 01/19


King Bio Inc.

Drugs





Class I

Lots: AUS-050516J Exp. 05/19; AUS-

030917D Exp. 03/20; AUS-

011916L Exp. 01/19; AUS-

011117H Exp. 01/20


King Bio Inc.

Drugs NET Remedies #12

Homeopathic Preparation, Class I

Lots: AUS-101116C Exp. 10/19; AUS-


King Bio Inc.



Product Type


Recall Recalling

Firm




050916A Exp. 05/19; AUS-

030917E Exp. 03/20; AUS-

011916M Exp. 01/19;

AUS091515K Exp. 09/18; AUS-

030816L Exp. 03/19

Drugs





Class I

Lots: AUS-011916B Exp. 01/19; AUS-

011117B Exp. 01/20; AUS-

030816B Exp. 03/19; AUS-

050516B Exp. 05/19; AUS-

081516G Exp. 08/19; AUS-

091515B Exp. 09/18


King Bio Inc.

Drugs





Class I

Lots: AUS-011916N Exp. 01/19; AUS-

050516K Exp. 05/19; AUS-091515J Exp. 09/18; AUS-

101416A Exp. 10/19


King Bio Inc.

Drugs





Class I

Lots: AUS-011916P Exp. 01/19; AUS-

030816M Exp. 03/19; AUS-

061016D Exp. 06/19; AUS-

081516A Exp. 08/19


King Bio Inc.

Drugs




Hume Street, Toowoomba

Class I

Lots: AUS-011916Q Exp. 01/19; AUS-

061016E Exp. 06/19


King Bio Inc.



Product Type


Recall Recalling

Firm

QLD 4350, Australia

Drugs





Class I


011916C Exp. 01/19; AUS-

030816C Exp. 03/19; AUS-

050516C Exp. 05/19; AUS-

061217A Exp. 06/20; AUS-

081516F Exp. 08/19; AUS-

091515C Exp. 09/18


King Bio Inc.

Drugs





Class I

Lots: AUS-011117D Exp. 01/20; AUS-

011916D Exp. 01/19; AUS-

030816D Exp. 03/19; AUS-

050516D Exp. 05/19; AUS-

061016A Exp. 06/19; AUS-

081516E Exp. 08/19; AUS-

091515D Exp. 09/18


King Bio Inc.

Drugs





Class I

Lots: AUS-011117E Exp. 01/20; AUS-

011916E Exp. 01/19; AUS-

030816E Exp. 03/19; AUS-

050516E Exp. 05/19; AUS-

101116A Exp. 10/19


King Bio Inc.

Drugs




Class I

Lots: AUS-011916F Exp. 01/19; AUS-

030816F Exp. 03/19; AUS-

050516F Exp. 05/19; AUS-


King Bio Inc.



Product Type


Recall Recalling

Firm


050517F Exp. 05/20; AUS-

081516D Exp. 08/19; AUS-

091515E Exp. 09/18

Drugs





Class I

Lots: AUS-011916H Exp. 01/19; AUS-

030816G Exp. 03/19; AUS-

030917A Exp. 03/20; AUS-

061016B Exp. 06/19; AUS-

091515F Exp. 09/18; AUS-

101116B Exp. 10/19


King Bio Inc.

Drugs





Class I


011916G Exp. 01/19; AUS-

030816H Exp. 03/19; AUS-

030917B Exp. 03/20; AUS-

050516G Exp. 05/19; AUS-

082616A Exp. 08/19; AUS-

091515G Exp. 09/18


King Bio Inc.

Drugs





Class I

Lots: AUS-011117G Exp. 01/20; AUS-

011916J Exp. 01/19; AUS-030816J Exp. 03/19; AUS-

030917C Exp. 03/20; AUS-

050516H Exp. 05/19; AUS-

081516B Exp. 08/19; AUS-

091515H Exp. 09/18


King Bio Inc.



Product Type


Recall Recalling

Firm

Drugs

NET Remedies #1 (Yellow Label) Homeopathic

Preparation, Oral Liquid, 57 mL, Manufacturer: King

Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD

428 Hume Street, Toowoomba QLD 4350,

Australia

Class I


071718N Exp. 07/20; AUS-

111317C Exp. 11/19


King Bio Inc.

Drugs

NET Remedies #10 (Maroon Label)

Homeopathic Preparation, Oral Liquid, 57 mL,

Manufacturer: King Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428


Class I

Lots: AUS-020118H Exp. 02/20; AUS-

102617A Exp. 10/19


King Bio Inc.

Drugs

NET Remedies #11 (Lilac Label) Homeopathic




Australia

Class I


100117D Exp. 10/19


King Bio Inc.

Drugs

NET Remedies #12 (Pink Label) Homeopathic




Australia

Class I

Lots: AUS-072018G Exp. 07/20; AUS-

100117E Exp. 10/19


King Bio Inc.

Drugs





Class I Lot: AUS-111517D

Exp. 11/19 Microbial


Inc.

Drugs NET Remedies #20 (Red, Class I Lot: AUS-031618A Microbial King Bio



Product Type


Recall Recalling

Firm

White and Blue Label) Homeopathic Preparation,




Exp. 03/20; AUS-111317A Exp. 11/19; AUS-

121717C Exp. 12/19

contamination Inc.

Drugs

NET Remedies #24 (Blue, White and Purple Label)

Homeopathic Preparation, Oral Liquid, 57 mL,

Manufacturer: King Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD 428


Class I

Lot: AUS-100117H Exp. 10/19; AUS-

020118J Exp. 02/20; AUS-

041618C Exp. 02/20


King Bio Inc.

Drugs

NET Remedies #25 (Yellow, White and Purple

Label) Homeopathic Preparation, Oral Liquid,

57 mL, Manufacturer: King Bio Inc. U.S.A. Supplier: NET (Australia) Pty LTD


Australia

Class I Lot: AUS-122017A

Exp. 12/19 Microbial


Inc.

Drugs

NET Remedies #3 (Blue Label) Homeopathic




Australia

Class I


031618J Exp. 03/20; AUS-

041718C Exp. 04/20; AUS-

121417A Exp. 12/19


King Bio Inc.

Drugs

NET Remedies #4 (Green Label) Homeopathic




Australia

Class I

Lots: AUS-071718R Exp. 07/20; AUS-

110117A Exp. 11/19


King Bio Inc.



Product Type


Recall Recalling

Firm

Drugs

NET Remedies #5 (Red Label) Homeopathic




Australia

Class I


022418B Exp. 02/20; AUS-

041718E Exp. 04/20; AUS-

071718S Exp. 07/20; AUS-

100117A Exp. 10/19


King Bio Inc.

Drugs

NET Remedies #6 (Orange Label) Homeopathic




Australia

Class I


022418C Exp. 02/20; AUS-

071718T Exp. 07/20; AUS-

101117C Exp. 10/19


King Bio Inc.

Drugs

NET Remedies #7 (Aqua Blue Label) Homeopathic Preparation, Oral Liquid,

57 mL, Manufacturer: King Bio Inc. U.S.A., Supplier: NET (Australia) Pty LTD


Australia

Class I

Lots: AUS-020118D Exp. 02/20; AUS-

110817A Exp. 11/19


King Bio Inc.

Drugs

NET Remedies #8 (Royal Blue Label) Homeopathic Preparation, Oral Liquid,

57 mL, Manufacturer: King Bio Inc. U.S.A. Supplier: NET (Australia) Pty LTD


Australia

Class I


020118E Exp. 02/20; AUS-

041718G Exp. 04/20; AUS-

071718W Exp. 07/20; AUS-

100117B Exp. 10/19


King Bio Inc.

Drugs

NET Remedies #9 (Fuschia Label) Homeopathic



428 Hume Street,

Class I


071718Y Exp. 07/20; AUS-

100117C Exp. 10/19


King Bio Inc.



Product Type


Recall Recalling

Firm

Toowoomba QLD 4350, Australia

Drugs

NET Remedies #8 Allergy Homeopathic Preparation,

Oral Liquid, 57 mL, NDC 57955-4208-2

Class I

Lots: NR-031516F Exp. 03/19; NR-073015E Exp.

07/18; NR-010617F Exp.

01/20; NR-011216F Exp.

01/19; NR-021717E Exp.

02/20; NR-051116C Exp.

05/19; NR-060517B Exp.

06/20; NR-061616G Exp.

06/19; NR-080116C Exp.

08/19; NR-090115E Exp.

09/18; NR-090616G Exp.

09/19; NR-101916A Exp.

10/19; NR-120815J Exp. 12/18


King Bio Inc.

Drugs

NET Remedies #24 Day & Night Vitals Homeopathic Preparation, Oral Liquid,

57 mL, NDC 57955-4214-2

Class I

Lots: NR-031516B Exp. 03/19; NR-021717H Exp.

02/20; NR-050916C Exp.

05/19; NR-061616M Exp.

06/19; NR-090916A Exp.

09/19; NR-101416M Exp.

10/19; NR-120815B Exp.

12/18


King Bio Inc.

Drugs

NET Remedies #1 Earth Homeopathic Preparation,


Class I

Lots: NR-031516N Exp. 03/19; NR-073015C Exp.

07/18; NR-010617A Exp.


King Bio Inc.



Product Type


Recall Recalling

Firm

01/20; NR-011216L Exp.

01/19; NR-021717A Exp.

02/20; NR-050916E Exp.

05/19; NR-060517A Exp.

06/20; NR-061616A Exp.

06/19; NR-080116D Exp.

08/19; NR-090115C Exp.

09/18; NR-090616A Exp.

09/19; NR-101416A Exp.

10/19; NR-120815A Exp.

12/18; NR-020118A Exp.

02/20; NR-022318A Exp.

02/20; NR-051618B Exp.

05/20; NR-071718E Exp.

07/20; NR-110817A Exp.

11/19; NR-103117A Exp.

10/19; NR-120317A Exp.

12/19

Drugs

NET Remedies #9 ER 911 Homeopathic Preparation,


Class I

Lots: NR-031816A Exp. 03/19; NR-073015F Exp.

07/18; NR-010617H Exp.

01/20; NR-011216C Exp.

01/19; NR-021717F Exp.

02/20; NR-050916A Exp.


King Bio Inc.



Product Type


Recall Recalling

Firm

10/19; NR-061716A Exp.

06/19; NR-080116B Exp.

08/19; NR-090115L Exp.

09/18; NR-090616H Exp.

09/19; NR-101916B Exp.

10/19; NR-120815H Exp.

12/18

Drugs

NET Remedies #5 Fire Homeopathic Preparation,


Class I

Lots: NR-022318E Exp. 02/20; NR-030418A Exp.

03/20; NR-051618D Exp.

05/20; NR-051818D Exp.

05/20; NR-081017E Exp.

08/19; NR-120317E Exp.

12/19; NR-121517A Exp.

12/19; NR-031516J Exp. 3/19; NR-010617E Exp.

01/20; NR011216H Exp. 01/19; NR-040417C Exp.

4/20; NR-050916D Exp. 5/19; NR-061517A Exp.

6/20; NR-061616D Exp. 6/19; NR-080116A Exp.

8/19; NR090115J Exp. 9/18; NR-090916B Exp.

9/19; NR-101416E Exp. 10/19; NR-

120815K Exp.12/18


King Bio Inc.



Product Type


Recall Recalling

Firm

Drugs

NET Remedies #7 Flora Plus Homeopathic

Preparation, Oral Liquid, 57 mL, NDC 57955-4207-2

Class I

Lots: NR-090115K Exp. 09/18; NR-031516G Exp.

03/19; NR-011216E Exp.

10/19; NR-021717D Exp.

02/20; NR-042717C Exp.

04/20; NR-061616F Exp.

06/19; NR-090616F Exp.

09/19; NR-101416G Exp.

10/19; NR-120815M Exp.

12/18; NR-020118H Exp.

02/20; NR-020618J Exp. 02/20; NR-081017H Exp.

08/19; NR-101117E Exp.

10/19


King Bio Inc.

Drugs

NET Remedies #12 Flu Immune Homeopathic


Class I

Lots: NR-010617L Exp. 01/20; NR-011216D Exp.

01/19; NR-021717G Exp.

10/19; NR-040417K Exp.

04/20; NR-061616K Exp.

06/19; NR-090115G Exp.

09/18; NR-090616K Exp.

09/19; NR-101416K Exp.

10/19; NR-120815D Exp.

12/18; NR-010318A Exp.

01/20; NR-020118N Exp.


King Bio Inc.



Product Type


Recall Recalling

Firm

02/20; NR-051618G Exp.

05/20

Drugs

NET Remedies #2 Metal Homeopathic Preparation,


Class I

Lots: NR-031516M Exp. 03/19; NR-073015D Exp.

09/19; NR-010617B Exp.

01/20; NR-011216M Exp.

01/19; NR-042717D Exp.

09/19; NR-051116B Exp.

05/19; NR-061616N Exp.

06/19; NR-080116E Exp.

08/19; NR-090115B Exp.

09/18; NR-090616B Exp.

09/19; NR-101416B Exp.

10/19; NR-120815R Exp.

12/18; NR-081017B Exp.

08/19; NR-020118B Exp.

02/20; NR-022318B Exp.

02/20; NR-101017B Exp.

10/19; NR-120317B Exp.

12/19


King Bio Inc.

Drugs

NET Remedies #20 Pain Relief Homeopathic


Class I

Lots: NR-010617M Exp. 01/20; NR-031516C Exp.

03/19; NR-061616L Exp.

06/19; NR-090115F Exp.

09/18; NR-090616M Exp.


King Bio Inc.



Product Type


Recall Recalling

Firm

09/19; NR-101416L Exp.

10/19; NR-120815C Exp.

12/18; NR-020118P Exp.

02/20; NR-022318K Exp.

02/20; NR-022318M Exp.

02/20; NR-052517A Exp.

05/20; NR-060517F Exp.

06/20; NR-060618A Exp.

06/20; NR-061418A Exp.

06/20; NR-121417B Exp.

12/19

Drugs

NET Remedies #6 Para Solve Homeopathic


Class I

Lots: NR-031516H Exp. 03/19; NR-011216G Exp.

01/19; NR-021717C Exp.

02/20; NR-040417D Exp.

04/20; NR-061616E Exp.

06/19; NR-090115H Exp.

09/19; NR-090616E Exp.

09/19; NR-101416F Exp.

10/19; NR-120815L Exp.

12/18; NR-020118F Exp.

02/20; NR-022318F Exp.

02/20; NR-052218A Exp.

05/20; NR-071718G Exp.


King Bio Inc.



Product Type


Recall Recalling

Firm

07/20; NR-101117G Exp.

10/19; NR-120317F Exp.

02/19; NR-110117D Exp.

11/19

Drugs

NET Remedies #10 Scars-Adhesions Homeopathic Preparation, Oral Liquid,

57 mL, NDC 57955-4210-2

Class I

Lots: NR-031516E Exp. 03/19; NR-073015G Exp.

07/18; NR-010617J Exp. 01/20; NR-011216B Exp.

01/19; NR-040417F Exp.

04/20; NR-060517D Exp.

10/19; NR-061616H Exp.

06/19; NR-080116H Exp.

08/19; NR-090616J Exp. 09/19; NR-101416H Exp.

10/19; NR-120815G Exp.

12/18; NR-020118L Exp.

02/20; NR-022318H Exp.

02/20; NR-051618F Exp.

05/20; NR-081017N Exp.

08/19; NR-110117B Exp.

11/19


King Bio Inc.

Drugs

NET Remedies #11 Visceral Polarity

Homeopathic Preparation, Oral Liquid, 57 mL, NDC

57955-4211-2

Class I

Lots: NR-031516D Exp. 03/19; NR-073015H Exp.

07/18; NR-010617K Exp.

01/20; NR-011216A Exp.

01/19; NR-050916B Exp.


King Bio Inc.



Product Type


Recall Recalling

Firm

05/19; NR-061616J Exp. 06/19; NR-

080116J Exp. 08/19; NR-

090115D Exp. 09/18; NR-

090816A Exp. 09/19; NR-101416J

Exp. 10/19; NR-120815F Exp.

12/18; NR-020118M Exp.

02/20; NR-072617A Exp.

07/19; NR-110117C Exp.

11/19; NR-120317L Exp.

12/19

Drugs

NET Remedies #3 Water Homeopathic Preparation,


Class I

Lots: NR-031516L Exp. 03/19; NR-010617C Exp.

01/20; NR-011216K Exp.

01/19; NR-050916F Exp.

05/19; NR-051917A Exp.

05/20; NR-061616B Exp.

06/19; NR-080116F Exp.

08/19; NR-090115A Exp.

09/18; NR-090616C Exp.

09/19; NR-101416C Exp.

10/19; NR-120815N Exp.

12/18; NR-020118C Exp.

02/20; NR-022318C Exp.

02/20; NR-051618A Exp.


King Bio Inc.



Product Type


Recall Recalling

Firm

05/20; NR-071718K Exp.

07/20; NR-081017C Exp.

08/19; NR-101017C Exp.

10/19; NR-120317C Exp.

12/19

Drugs

NET Remedies #4 Wood Homeopathic Preparation,


Class I

Lots: NR-031516K Exp. 03/19; NR-010617D Exp.

01/20; NR-011216J Exp. 01/19; NR-021717B Exp.

02/20; NR-051116A Exp.

05/19; NR-060217C Exp.

06/20; NR-061616C Exp.

06/19; NR-080116G Exp.

08/19; NR-090215A Exp.

09/18; NR-090616D Exp.

09/19; NR-101416D Exp.

10/19; NR-120815P Exp.

12/18; NR-081017D Exp.

08/19; NR-020118D Exp.

02/20; NR-071018A Exp.

07/20; NR-071018C Exp.

07/20; NR-071018E Exp.

07/20; NR-110317A Exp.

11/19; NR-120317D Exp.

12/19


King Bio Inc.



Product Type


Recall Recalling

Firm

Drugs

NET Remedies #25 Yin/Yang Balance

Homeopathic Preparation, Oral Liquid, 57 mL, NDC

57955-4215-2

Class I

Lots: NR-031516A Exp. 03/19; NR-042717B Exp.

04/20; NR-090616N Exp.

09/19; NR-100115A Exp.

10/18; NR-120815E Exp.

12/18; NR-020118T Exp.

10/19; NR-022318L Exp.

02/20; NR-022318P Exp.

10/19; NR-092717A Exp.

09/19


King Bio Inc.

Drugs

NET Remedies #8 Allergy (Blue Label) Homeopathic Preparation, Oral Liquid,

57 mL, NDC 57955-4208-2

Class I

Lots: NR-020618A Exp. 02/20; NR-051618E Exp.

05/20; NR-051818B Exp.

05/20; NR-101117D Exp.

10/19; NR-020118J Exp. 02/20; NR-092717B Exp.

09/19


King Bio Inc.

Drugs

NET Remedies #24 Day & Night Vitals Homeopathic Preparation, Oral Liquid,

57 mL, NDC 57955-4214-2

Class I

Lots: NR-020118R Exp. 02/20; NR-071318A Exp.

07/20; NR-071318C Exp.

07/20; NR-092517A Exp.

09/19; NR-110117E Exp.

11/19; NR-120317P Exp.

12/19


King Bio Inc.

Drugs

NET Remedies #9 ER 911 Homeopathic Preparation,


Class I

Lots: NR-071118A Exp. 07/20; NR-071218A Exp.

07/20; NR-071218C Exp.


King Bio Inc.



Product Type


Recall Recalling

Firm

07/20; NR-081017M Exp.

08/19; NR-110117H Exp.

11/19; NR-020118K Exp.

02/20; NR-111517C Exp.

11/19; NR-120317J Exp. 12/19

Drugs

Dr. King's Acute Pain Relief Cooling Topical, 89

mL (topical cream), Manufactured by: King Bio, Inc. 3 Westside Dr.

Asheville, NC 28806 Imported by Ambiental

Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM

80074489 UPC 357955181439

Class I Lot: 020417ZZ Exp.

02/20 Microbial


Inc.

Drugs

Dr. King's Advanced Arnica Super Arnica, 59 mL,

Manufactured by: King Bio, Inc. 3 Westside Dr.



800774305 UPC 357955181224

Class I Lot: 013117P Exp.

01/20 Microbial


Inc.

Drugs

Dr. King's Arthritis Pain & Joint Relief Soulagement De La Douleur Arthritique

et Articulaire, 59 mL, (liquid/liquid) DIN-HM

80035118 UPC 357955180425


01/19; 081516F Exp. 08/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Aquaflora

Candida High Potency 9 Multi-Strain Candida

Formula, 236 mL, (liquid/liquide), Manufactured

Class I

Lots: 022218E Exp. 02/20; 011217C

Exp. 12/20; 012116A Exp.

01/19; 092816A Exp. 09/19


King Bio Inc.



Product Type


Recall Recalling

Firm

by:/Fabrique par: King Bio, Inc. 3 Westside Dr.,

Asheville, NC 28805 USA Import by: Importe par: Ambiental Solutions Inc. Vancouver, BC, V5Y 1E6, DIN-HM 80036805 UPC

357955180289

Drugs

Dr. King's Natural Medicine Anxiety & Nervousness, 59 mL,

(liquid/liquide), DIN-HM 80074778 UPC 357955181521


06/20; 021517J Exp. 02/20


King Bio Inc.

Drugs

Dr. King's Natural Medicine Regional

Allergies Eastern Canada, 59 mL, (liquid/liquide)

DIN-HM 80075212 UPC 357955181620


06/20; 021517K Exp. 02/20


King Bio Inc.

Drugs

Dr. King's Natural Medicine Multi-Strain Flu

Relief, 59 mL, (liquid/liquid), DIN-HM

80038065 UPC 357955180128


01/19; 081516E Exp. 08/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Regional Allergies Canadian

Prairies, 59 mL (liquid/liquide), DIN-HM

80074815 UPC 357955181729


02/20 Microbial


Inc.

Drugs

Dr. King's Natural Medicine Stress Control, 59 mL, (liquid/liquide), DIN-HM 80041740 UPC

357955180524


01/19; 081516G Exp. 08/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Respiratory

Care, 59 mL, (liquid/liquide), DIN-HM

80035323 UPC 357955180623


01/19; 082216B Exp. 08/19


King Bio Inc.

Drugs Dr. King's Natural Class I Lot: 021517M Exp. Microbial King Bio



Product Type


Recall Recalling

Firm

Medicine Regional Allergies Western Canada,

59 mL, (liquid/liquide), DIN-HM 80074875 UPC

357955181828


Drugs

Dr. King's Appetite Enhancer Homeopathic, 2

fl oz (59 mL), King Bio, Inc., 3 Westside Dr.

Asheville, NC 28806 USA, UPC 357955512820


12/19 Microbial


Inc.

Drugs

Dr. King's SafeCare Rx Allergies Pacific U.S.

Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3


357955260820, NDC 57955-2717-2

Class I

Lots: 030518R Exp. 03/20; 062415F

Exp. 06/18; 072015B Exp.

07/18


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Aller-Detox: Outdoor

Pollution Control Homeopathic, 2 fl oz (59


28806 USA, UPC 357955240426, NDC

57955-2404-2


07/18; 070116A Exp. 06/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Melancholic



357955201021, NDC 57955-2011-2


01/20; 051216L Exp. 05/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Sinus Relief High Potency

Homeopathic Formula, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC

28806 USA, UPC 357955013426, NDC

57955-0134-2

Class I Lots: 120816J Exp.

12/19; 123115C Exp. 12/18


King Bio Inc.

Drugs Dr. King's SafeCare Rx Class I Lots: 012317G Exp. Microbial King Bio



Product Type


Recall Recalling

Firm

Hyperactive High Potency Homeopathic Formula, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC

28806 USA, UPC 357955151029, NDC

57955-1511-2


Drugs

Dr. King's Advanced Arnica Super Arnica, 59 mL,

Manufactured by: King Bio, Inc. 3 Westside Dr.



800774304 UPC 357955181330

Class I Lot: 050117ZZ Exp.

05/20 Microbial


Inc.

Drugs

Dr. King's Bronchial Care, 59 mL (liquid/liquid),

Manufactured by: King Bio, Inc., 3 Westside Dr.



80035774 UPC 357955180425


11/19 Microbial


Inc.

Drugs

Dr. King's Natural Medicine Kids Aquaflora

Candida Multi-Strain Formula, 118 mL (liquid), Manufactured by: King Bio, Inc., 3 Westside Dr.

Asheville, NC 28806, Imported by Ambiental


80074869 UPC 357955181941


04/20 Microbial


Inc.

Drugs

Dr. King's SafeCareRx CS-Lung High Potency

Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC

Class I

Lots: 052516M Exp. 05/19;

052815E Exp. 05/18


King Bio Inc.



Product Type


Recall Recalling

Firm

28806 USA, UPC 357955022626, NDC

57955-0226-2

Drugs

Dr. King's Natural Medicine Bug Away



357955507726, NDC 57955-5077-2

Class I

Lots: 071116B Exp. 07/19; 050516B

Exp. 05/19; 020116A Exp.

07/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Good Mood

Enhancer Homeopathic, 2 fl oz (59 mL), King Bio,

Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955515029, NDC

57955-8150-2

Class I

Lots: 041117E Exp. 04/20; 030118H

Exp. 03/20; 040616F Exp.

04/19; 071316N Exp. 07/19;

111617C Exp. 11/19


King Bio Inc.

Drugs

Dr. King's Natural Medicine Leg Cramp &

Spasm Relief Homeopathic, 2 fl oz (59


28806 USA, UPC 357955543527, NDC

57955-6035-2

Class I

Lots: 102816D Exp. 10/19; 050516F

Exp. 05/19; 101416A Exp.

10/19; 123115D Exp. 12/18;

041518J Exp. 04/20


King Bio Inc.

Drugs

Dr. King's Natural Medicine Regional

Allergies Hawaii U.S. Homeopathic, 2 fl oz (59


28806 USA, UPC 357955520620, NDC

57955-5206-2

Class I

Lots: 050216M Exp. 05/19;

070516A Exp. 07/19


King Bio Inc.

Drugs

Dr. King's SafeCare Rx Aversion to Change High

Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806

USA, UPC 357955280026,

Class I

Lots: 072015H Exp. 07/18; 111016E

Exp. 11/19; 011917N Exp.

01/20


King Bio Inc.



Product Type


Recall Recalling

Firm

NDC 57955-2800-2

Drugs

Dr. King's SafeCare Rx Breast Cyst & Discomforts

High Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC

28806 USA, UPC 357955000327, NDC

57955-0003-2


04/19; 020917G Exp. 02/20


King Bio Inc.

Drugs

Levoleucovorin Injection, 250 mg/25 mL, (10

mg/mL), 25 mL Single-Use Vial, Rx only,

Manufactured for: Mylan Institutional LLC,

Rockford, IL 61103 U.S.A., Made in India. NDC:

67457-601-30

Class I Lot #: APB032,

APB033, Exp. April 2019

Presence of Particulate

Matter: particulate

matter identified as copper salts

Mylan Institution

al Inc

Drugs

Golean DETOX capsules, 14 Net: 56 g, 14 packets

containing 2 capsules per packet, 28-count capsules per box, MAT XI S.G Co., LTD, Head office: J29 Vo

Thi Sau Street, Thong Nhat Ward, Bien Hoa City, Dong

Nai Province, Viet Nam; Manufactory: 148/9 Tan

Tien Ward, Bien Hoa City, Dong Nai Province, Viet

Nam; Product distribution franshise by GoLean Detox

Enterprise 002677155-A Malaysia,

www.matxisg.com, UPC 8 938510 909013.

Class I All lots remaining

within expiry.

Marketed Without an Approved

NDA/ANDA: FDA analysis found

product to contain

undeclared sibutramine and phenolphthalein. Sibutramine is

an appetite suppressant

that was withdrawn from the US market due to safety

concerns. Phenolphthalein

was once an ingredient used

in over-the-counter

laxatives, but because of

Golean Detox US



Product Type


Recall Recalling

Firm

concerns of carcinogenicity is not currently approved for

marketing in the US. The

presence of sibutramine and phenolphthalein in this product renders it an unapproved

drug for which the safety and

efficacy has not been

established and, therefore,

subject to recall.

Drugs

LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a)

30-count (NDC: 13668-115-30), b) 90-count

(NDC: 13668-115-90), c) 1000-count (NDC: 13668-

115-10) per bottle, Rx only, Manufactured by:

Torrent Pharmaceuticals LTD, Indrad-382 721, Dist.

Mehsana Inda

Class II

Count, lots, expiry: [30-count bottle]

Lot BO31C016, exp 04/2019; [90-

count bottle] Lot BO31C016, exp 04/2019; [1000-

count bottle] Lots 4DK3C004,

4DK3C005, exp 04/2019; Lots

4DU3C040, exp 10/2019; Lots

4DU3E049, 4DU3E050, exp

05/2021

CGMP Deviations: FDA lab confirmed presence an impurity, N-

nitrosodimethylamine (NDEA)

contained in the API used to

manufacture the product above the

interim acceptable daily intake level of

0.083 parts per million.

Torrent Pharma

Inc.

Drugs

LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b) 90-

count bottle (NDC: 13668-409-90), c) 1000-count

bottle (NDC: 13668-409-10), Rx only,

Manufactured by: Torrent Pharmaceuticals LTD,

Class II


Lot 4L67C035, exp 10/2019; [90-

count bottle] Lot 4L67C035,

4L67C036 exp 10/2019; [1000-count bottle] Lot 4O50C005, exp




manufacture

Torrent Pharma

Inc.



Product Type


Recall Recalling

Firm

Indrad-382 721, Dist. Mehsana Inda

11/2019 the product above the



Drugs

LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-

113-90), Rx only, Manufactured by: Torrent

Pharmaceuticals LTD, Indrad-382 721, Dist.

Mehsana Inda

Class II


Lot 4O49C013, exp 09/2019







Torrent Pharma

Inc.

Drugs

LOSARTAN POTASSIUM and

HYDROCHLOROTHIAZIDE TABLETS, USP, 100

mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by:

Torrent Pharmaceuticals LTD, Indrad-382 721, Dist.

Mehsana Inda

Class II


Lot BX35C020, exp 05/2019, Lot

BX35C049, exp 08/2019; [1000-

count bottle] Lots BX35C022,

BX35C023, exp 05/2019







Torrent Pharma

Inc.

Drugs

LOSARTAN POTASSIUM and

HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5

mg, a) 90-count bottle

Class II


Lot BP02C008, exp 03/2019; [1000-

count bottle] Lots


Torrent Pharma

Inc.



Product Type


Recall Recalling

Firm

(NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only,

Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist.

Mehsana Inda

BEF7D006, exp 03/2020






Drugs

Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding Pharmacy 1270 Don's Lane Conway,

AR 800-718-3588, Barcode: 62295308407

Class II Lot: 20181812@2 BUD: 06/16/2019

Lack of assurance of

sterility.

US Compounding Inc

Drugs

0.9% Sodium Chloride Injection, USP 1000 mL

flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-

7983-09

Class II Lot #: 91-016-JT,

Exp. July 01, 2020 CGMP

Deviations

ICU Medical

Inc

Drugs

Divalproex Sodium Extended-release Tablets,

USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-

533-01

Class II Lot #: C802676,

Exp 03/20

Failed Dissolution

Specifications: Out of

specification results observed

for high dissolution.

Dr. Reddy's

Laboratories, Inc.

Drugs

tubby todd Bath Co, 100% NATURAL DREAM CREAM, Shea Butter and Mint, 3.5 FL OZ 99G, Distributed by:

Tubby Todd Bath Co. Vista, CA 920, (619) 894-

6560.

Class II Lot#: 5589, Exp.

08/2017

Microbial Contamination of Non-Sterile

Products: Consumer

complaint and subsequent

testing found lot to be out of

specification for mold.

Mariposa Labs LLC

Drugs Fentanyl in 0.9% Sodium Class II Lot#: 12/31/18 Labeling: Advanced



Product Type


Recall Recalling

Firm

Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1

mL of overfill Injectable Solution, Sterile single use syringe, Rx only, Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404, NDC 42852-

210-72

0555 21072S, Exp 3/31/2019

Incorrect expiration date.

Pharma Inc.

Drugs

Moisturizing Lubricant Eye Drops, 0.25% Sodium

Carboxymethylcellulose, 0.5 Fl OZ (15mL)

Distributed by: Walgreen Co, 200 Wilmont Rd

Deerfield IL 60015 NDC 00363-9651-01.

Class II

Lot # 8D31A, Exp: 03/20; 7H98A,

Exp: 07/19; 7L80A, Exp: 10/19.

Failed Stability Specification:

out of specification

results for Sodium

Perborate

Akorn Inc

Drugs

Topical Solution USP Hydrogen Peroxide First

Aid Antiseptic Oral Debriding Agent 32 Fl. Oz.

(1 QT) 946 mL bottle, Distributed By: Discount

Drug Mart 211 Commerce Drive, Medina, Ohio

44256 NDC 53943-871-45 UPC 0-93351-12758-8

Class II Lot: 0384244 Exp.

01/2020

Cross Contamination: Presence of IPA

in finished product.

Vi-Jon, Inc.

Drugs

Cefuroxime 10 mg/mL in Sodium Chloride,

Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only,

Leiter's (800) 292-6772- 17 Great Oaks Blvd., San

Jose, CA 95119. NDC: 70360-007-35.

Class II Lot # 1811195,

Exp. Date: 05/01/19

Incorrect Product

Formulation; compounded sterile drug

reconstituted using sterile

water instead of sterile 0.9%

Sodium Chloride.

Leiter's Enterprise

s, Inc.

Drugs

Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets

Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1

Unit per carton (NDC

Class II

Lots: 7DY008A, 7DY009A, 7DY010A,

7DY011A, Exp. 08/2020

Contraceptive Tablets Out of

Sequence: Missing or

incorrect tablet placement.

Apotex Inc.



Product Type


Recall Recalling

Firm

60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Products Co. L.L.C., P.O. Box 1885, Postal Code 111, Seeb.

Drugs

Telmisartan and Hyrdochlorothiazide

Tablets 40mg/12.5 mg, 30-count bottles, Rx Only,

Manufactured for:Macleods Pharma

USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals

Ltd. Baddi, Himchal Pradesh INDIA, NDC

33342-128-07

Class II

Lot #: BTL703A, Exp. Feb-19;

BTL705A, Exp Apr-19; BTL706A,

BTL707A, BTL708A, Exp May-19;

BTL709A, Exp Nov-19; BTL710A,

BTL711A, BTL801A, Exp. Dec-19;

BTL802A, BTL803A, Exp.Feb-20;

BTL804A, BTL805A, Exp. Apr-20;

BTL807A, BTL807B, Exp May- 20;

BTL809A, BTL810A, Exp Jul-20;

BTL811A, Exp Sep-20; BTL812A,

BTL813A Exp Oct-20

Failed Content Uniformity

Specifications: The product is

out of specification for

blend uniformity.

Macleods Pharma Usa Inc

Drugs


Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA,

Inc. Plainsboro, NJ 08536 Manufactured by:

Macleods Pharmaceuticals Ltd. Baddi, Imachal

Pradesh, India NDC 33342-129-07

Class II

Lot #: BTM703A, BTM704A, BTM706A,

BTM707A, Exp Feb-19;

TM708A,BTM709A, Exp Apr-19;

BTM710A, Exp Jun-19; BTM711A, BTM712A, Exp

Oct-19; BTM713A,BTM714A, BTM715A, Exp

Nov-19; BTM801A, BTM802A, BTM803A,




blend uniformity.




Product Type


Recall Recalling

Firm

BTM804A, Exp Dec-19;

BTM806A,BTM807A, Exp Mar-20;

BTM809A Exp Apr-20; BTM810A,

BTM811A, BTM812A, Exp. Jul-

20; BTM813A, BTM814A, BTM815A, BTM816A,

BTM817A, Exp Sep-20; BTM818A, BTM819A Exp Nov-

20.

Drugs


Tablets 80 mg/25 mg, 30-count bottles, Rx Only,

Manufactured for: Macleods Pharma USA,

Inc. Plainsboro, NJ 08536 Manufactured by:

Macleods Pharmaceuticals Ltd. Baddi Himachal Pradesh, INDIA, NDC

33342-130-07

Class II

Lot #: BTN703A, BTN704A Exp Feb-

19; BTN705A, BTN706A, Exp

May-19; BTN707A, Exp Jun-19;

BTN810A, Exp Jun-20; BTN811A,

BTN812A Exp Aug-20; BTN813A,

BTN814A, Exp Sep-20; BTN802A,

BTN802B, BTN803A,

BTN804A, Exp Dec-19; BTN805A,

BTN806A, BTN807A,

BTN807B, Exp Feb-20; BTN808A, Exp Apr-20; BTN809A,

BTN810A, Exp Jun-20; BTN811A,

BTN812A, Exp Aug-20; BTN813A,

BTN814A, Exp Sep-20.




blend uniformity.


Drugs Gentamicin Sulfate

Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only,

Class II Lot 7B71A, Exp

01/2020

Failed Impurities/Degr

adation

Akorn, Inc.



Product Type


Recall Recalling

Firm

Manufactured for: Akorn, Inc., Lake Forest, IL 60045;

NDC 17478-283-10.

Specifications: High Out-of-Specification

(OOS) results for Individual and

Total Impurities that have been identified at the

18 months stability testing

time point.

Drugs

Oxygen, Refrigerated Liquid USP, Rx only,

cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home

Medical, Inc. Germantown, MD. 20875

Class II

Lot # 01005100518, 01010101918, 01011101918, 01007112118, 01001100318, 01007072518, 01017120518, 01011090518,

01002100318. No expiration date,

but an evaporation rate of

approximately 60 days from fill date

depending on head pressure of

reservoir.

CGMP Deviations

Roberts Home

Medical LLC

Drugs

Mometasone Furoate Cream, 0.1%, 45 g tube, Rx

Only, Manufactured by: G&W Laboratories, Inc.

South Plainfield, NJ 07080, NDC 0713-0726-37

Class III

Lot #: 1009431, 1009507, Exp.

08/2020; 1009886, Exp. 09/2020

Labeling: Not Elsewhere Classified.

Mometasone Furoate Cream

has an NDC typographical

error.

ACP Nimble Buyer,

Inc.

Drugs

Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a)

100-count bottles (NDC 0378-5280-01), and b)

500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan

Pharmaceuticals Inc.

Class III Lot #: 3090167,

Exp. October 2019


adation Specifications:

High out of specification

results obtained during routine stability testing

Mylan Pharmace

uticals Inc.



Product Type


Recall Recalling

Firm

Morgantown, WV, 26505

Drugs

Oxytocin 10 Units added to NS 1000 mL (oxytocin

and 0.9% Sodium Chloride) Injectable

Solution, Approximately 1001 mL Sterile single use

bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC

42852-730-99.

Class III Lot: 12/20/18 1056

73099P, BUD: 02/03/2019

Superpotent Drug: product may contain

concentrations of oxytocin higher than

what is represented on

the label.

Advanced Pharma

Inc.

Drugs



Solution, Approximately 1002 mL Sterile single use

bag, Rx only, Avella of Houston, 9265 Kirby Dr., Houston, TX 77054, NDC

42852-703-99.

Class III

Lots: 12/14/18 1482 70399P,

BUD: 02/27/19; 12/14/18 1610 70399P, BUD:

02/27/19




the label.

Advanced Pharma

Inc.

Drugs



Solution, Approximately 503 mL Sterile single use bag, Rx only, Avella of

Houston, 9265 Kirby Dr., Houston, TX 77054, NDC

42852-706-50.

Class III

Lots: 11/27/18 3177 70650P,

BUD: 02/10/2019; 11/27/18 6618 70650P, BUD: 02/10/2019;

11/28/18 7716 70650P, BUD:

02/12/19; 12/31/18 5698 70650P, BUD:

03/16/19




the label.

Advanced Pharma

Inc.

Drugs

Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram (NDC 50383-270-60) tubes, Rx

only. Manufacturer: Akorn Inc. 369 Bayview Ave., Amityville, NY 117701.

Class III

a) 357052, exp 4/19/19 b) 356892, exp 4/16/19 and 356927, exp

4/15/19

Failed Stability Specification;

out of specification

(OOS) results for a preservative

at 9 month stability study.

Akorn Inc

Drugs

Lovastatin Tablets USP, 40 mg, packaged in a) 60-

count (NDC 68180-469-07 and b) 100-count (NDC

Class III

Lot #: a) G702755, Exp March 2020; b) G702756, Exp

March 2020

CGMP Deviations:

Finished product made

Lupin Pharmace

uticals Inc.



Product Type


Recall Recalling

Firm

68180-469-01) bottles, Rx only, Manufactured for: Lupin Pharmaceuticals,

Inc., Baltimore, Maryland 21202; Manufactured by:

Lupin Limited, Goa 403 722 INDIA.

with lovastatin drug substance that was out of specification for

individual impurity results.

Drugs

Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo

Bronx, NY 10457 Distributed by Perrigo

Allegan, MI 49010, 45802-401-09

Class III Lot #: 7DT0280, 7ET0565, Exp.

02/19

Failed Degradation/Im

purities Specifications:

Out of specification

related substance

results during stability testing.

Perrigo New York,

Inc.

Drugs

Temozolomide Capsules, 5 mg, packaged in a) 5-

count bottle (NDC 43975-252-05) b) 14-count bottle

(NDC 43975-252-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc.,

Irvine, CA 92618, Dist. By: Amerigen

Pharmaceuticals, Lyndhurst, NJ 07071

Class III

Lot #: a) 18J043A, Exp 09/30/2020, b)

18J043B, Exp 09/30/2020

Failed dissolution

specifications

Amerigen Pharmace

uticals Inc.

Drugs

Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL

bottle, Rx only, Manufactured by: Lupin

Limited, Pithampur (M.P.) 454 775, INDIA, NDC

68180-422-01.

Class III

Lots: H701618, H701619,

H701620, Exp March 2019;

H702220, H702221, H702222, H702223, H702224, H702225,

H702351, Exp April 2019; H702971,

H702972, H702973, H702974, H703151, H703152,

H703153, Exp June


adation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-

specification for impurities.

Lupin Pharmace

uticals Inc.



Product Type


Recall Recalling

Firm

2019; H703155, H703682,

H703683, Exp July 2019; H704243,

H704245, H704247, Exp

September 2019; H704707, H704709, H705038,

H705039, Exp October 2019; H705561, Exp

November 2019; H800394, H800395, H800617,

H800618, Exp January 2020;

H801585, H801586, H801721,

H801722, Exp March 2020;

H802138, H802139,

H802140, Exp April 2020; H802421,

H802707, H802718, Exp May

2020; H803187, H803188,

H803232, Exp June 2020; H803749,

H803750, Exp July 2020; H804326,

H804327, H804328, H804330, H804549, H804552, H804630,

H804632, Exp September 2020;

H805163, H805361,



Product Type


Recall Recalling

Firm

H805362, H805676, Exp

November 2020; H805690, H805692,

H805694, Exp December 2020

Drugs

BuPROPion Hydrochloride Extended-Release Tablets,

USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC

59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd,

Roorkee, India, Marketed by: Jubilant Cadista

Pharmaceuticals Inc., Salisbury, MD

Class III

a) BR117002C, exp. date 11/2019; b) BR117003B and BR117004B, exp.

date 11/2019

Failed Dissolution

Specifications; 9-month stability

timepoint

Jubilant Cadista

Pharmaceuticals,

Inc.

Drugs

ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4

litres/1.1 US Gallon bottles, packaged in 4 x 4 Litres/1.1 US gallons per

case, Petra Hygienic Systems, Concord, ON L4K

4RS/ Reno, NV 89511, NDC 42326-550-01, UPC 0

65936 10335 5.

Class III All Lots

Does Not Meet Monograph:

product contains,

triclosan, an ingredient that

can no longer be contained in

over-the-counter

consumer antiseptic/antib

acterial wash products.

Petra Hygienic Systems Int Ltd

Drugs

Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx

Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154

NDC: 62175-271-37

Class III

Lots: 18226783A, exp 07/2021 and 18232540A, exp

08/2021

Failed Dissolution

Specifications

Lannett Company

Inc.

Drugs

Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and

b) 500 tablets (NDC

Class III

Lots: a) 22738 Exp. 07/2020 and b)

22739 Exp. 07/2020

Failed Dissolution

Specifications

AVKARE Inc.



Product Type


Recall Recalling

Firm

42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN

38478

Drugs

Mirapex (pramipexole dihydrochloride) Tablets,

1 mg, 100-count unit-dose tablets per folding carton,

Rx only, Distributed by: Boehringer Ingelheim (BI)

Pharmaceuticals, Inc., Ridgefield, CT 06877 USA,

Made in Germany, NDC 0597-0190-61.

Class III Lot # AA3280A, Exp SEP 2019

Failed Tablet/Capsule Specifications:

identification of low weight

tablets during routine stability

testing.

Boehringer

Ingelheim Pharmace

uticals, Inc.

*Please refer to FDA website for further information at: http://www.fda.gov/Safety/Recalls/default.htm



CURRENT DRUG SHORTAGES

Magnesium Sulfate Injection

February 21, 2019

Reason for the Shortage

American Regent is not currently marketing magnesium sulfate which has been unavailable since late

2012.

Fresenius Kabi has magnesium sulfate injection on shortage due to increased demand for the

product.

Pfizer has magnesium sulfate injection on shortage due to manufacturing delays.

X-Gen discontinued magnesium sulfate in April 2018.

Exela launched magnesium sulfate vials in May 2018.

WG Critical Care had magnesium sulfate injection on shortage due to increased demand for the

product.

Estimated Resupply Dates

Fresenius Kabi has magnesium sulfate 500 mg/mL 50 mL vials on back order and the company

estimates a release date of late-March 2019. Check wholesalers for inventory.

Pfizer has magnesium sulfate 500 mg/mL 20 mL vials on back order and the company estimates a

release date of December 2019. The 500 mg/mL 10 mL syringes are on back order and the company

estimates a release date of March 2019. The magnesium sulfate 40 mg/mL 1000 mL bags are on back

order and the company estimates a release date of March 2019. The 40 mg/mL 50 mL and 100 mL

bags and 80 mg/mL 50 mL bags are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=21

Losartan and Hydrochlorothiazide Tablets

February 22, 2019

Reason for the Shortage Cadista did not provide a reason for the shortage.

Lupin did not provide a reason for the shortage.

Merck has Hyzaar tablets available.

Rising did not provide a reason for the shortage.

Sandoz recalled one lot of losartan and hydrochlorothiazide 100 mg/25 mg in 1000 count bottles in November 2018 due to an impurity found in the active pharmaceutical ingredient. Additional information can be found at https://www.fda.gov/Safety/Recalls/ucm625492.htm.

Torrent recalled certain lots of 50 mg/ 12.5 mg in 90 and 1000 count bottles and 100mg/ 12.5 mg in 90 and 1000 count bottles in December 2018 and January 2019 due to an impurity found in the active pharmaceutical ingredient. Additional information can be found at https://www.fda.gov/Safety/Recalls/ucm629693.htm.

Torrent has losartan and hydrochlorothiazide tablets available in all presentations (from lots unaffected by the recall).

Teva did not provide a reason for the shortage.


Cadista has losartan and hydrochlorothiazide tablets on back order and the company cannot estimate a release date.



Lupin has losartan and hydrochlorothiazide tablets on allocation.

Rising has losartan and hydrochlorothiazide tablets on back order and the company cannot estimate a release date.

Sandoz has losartan and hydrochlorothiazide tablet presentations on back order and the company cannot estimate a release date.

Teva has losartan and hydrochlorothiazide 50 mg/12.5 mg tablets in 30, 90, and 1000 count bottles and 100 mg/12.5 mg tablets in 90 count bottles on back order and the company estimates a release date in early-June 2019. The 100 mg/12.5 mg tablets in 30 count and 1000 count bottles are on back order and the company estimates a release date in late-May 2019. The 100 mg/25 mg tablets in 30, 90, and 1000 count bottles are on back order and the company estimates a release date in late-June 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=529 Leuprolide Acetate 14-Day Kit February 25, 2019 Reason for the Shortage

Sun Pharma did not provide a reason for the shortage.

Sandoz states the reason for the shortage was increased demand.

Teva is not currently marketing leuprolide injection.

Estimated Resupply Dates Sun Pharma has leuprolide acetate injection on back order and the company cannot estimate a

release date.


Letermovir Injection

February 25, 2019


Merck has Prevymis on shortage due to a supply disruption.


Merck has Prevymis 20 mg/mL 12 mL and 24 mL vials on back order and the company cannot

estimate a release date.


Gentamicin Sulfate Ophthalmic Ointment

February 26, 2019


Akorn has Gentak ophthalmic ointment on shortage due to manufacturing delays.

Gentamicin ophthalmic solutions are not affected by this shortage.


Akorn has Gentak 3.5 gram tubes on allocation.




Calcitriol Injection

February 26, 2019


Akorn did not provide a reason for the shortage.

American Regent has not had product for several years.


Akorn has calcitriol 1 mcg/mL 1 mL ampules on allocation.


Atropine Ophthalmic Solution

February 26, 2019


Akorn did not provide a reason for the atropine ophthalmic solution shortage.

Altaire has homatropine ophthalmic solution available.


Akorn has atropine ophthalmic solution in 5 mL, 10 mL, and 15 mL bottles on allocation.


Isocarboxazid Tablets

February 27, 2019


Validus has Marplan tablets on shortage due to manufacturing delays.


Validus has Marplan on long-term back order and the company cannot estimate a release date.


Enoxaparin Sodium Injection

February 28, 2019


Amphastar has enoxaparin on intermittent back order due to increased demand.

Apotex launched enoxaparin in early-2019.

Fresenius Kabi did not provide a reason for the shortage.

Sandoz discontinued enoxaparin presentations in mid-2018 due to a supplier issue.

Sanofi-Aventis did not provide a reason for the shortage.


Winthrop did not provide a reason for the shortage.


Amphastar has enoxaparin 120 mg/0.8 mL prefilled syringes available in limited supply.

Fresenius Kabi has enoxaparin 120 mg/0.8 mL prefilled syringes on back order and the company

estimates a release date in mid- to late-March 2019.

Sanofi-Aventis has all Lovenox prefilled syringes on allocation.



Teva has enoxaparin 150 mg/1 mL, 120 mg/0.8 mL, 100 mg/1 mL, and 80 mg/0.8 mL prefilled

syringes on allocation.

Winthrop has all enoxaparin prefilled syringes on allocation.


Clomiphene Citrate Tablets

February 28, 2019


Par did not provide a reason for the shortage. They are the sole suppliers of clomiphene citrate

tablets.


Par has clomiphene citrate 50 mg tablets on long-term back order and the company cannot estimate

a release date


Diclofenac Potassium Tablets

February 28, 2019


Mylan did not provide a reason for the shortage.


Sandoz discontinued diclofenac potassium tablets.


Mylan has diclofenac potassium 50 mg tablets on back order and the company estimates a release

date of late-April to early-May 2019.

Teva has diclofenac potassium 50 mg tablets in 100 count and 500 count on back order and the

company estimates a release date of early-June 2019.


Ciprofloxacin Oral Suspension

March 1, 2019



Bayer has Cipro oral suspension available.


Lupin has ciprofloxacin oral suspension on long-term back order and the company cannot estimate a

release date.


Clindamycin Phosphate Injection

March 1, 2019


Alvogen did not provide a reason for the shortage.




Baxter has clindamycin injection available.


Pfizer did not provide a reason for the shortages. Pfizer discontinued Cleocin premixed bags in 2018.

Sagent has clindamycin injection available.

Sandoz has clindamycin injection available.


Akorn has clindamycin 600 mg/50 mL and 900 mg/50 mL in 5% dextrose premixes on back order and

the company cannot estimate a release date.

Alvogen has clindamycin 150 mg/mL 2 mL, 4 mL, and 6 mL ADD-Vantage vials on back order and the

company estimates a release date of 2nd quarter 2019.

Baxter has clindamycin 600 mg/50 mL in 5% dextrose on back order and the company cannot


Fresenius Kabi has short-dated clindamycin 150 mg/mL 4 mL and 6 mL vials available with an

expiration date of <9 months for the 4 mL vials and <8 months for the 6 mL vials.

Pfizer has Cleocin 150 mg/mL 2 mL, 4 mL, and 6 mL ADD-Vantage vials on back order and the

company estimates a release date of September 2019.


Desiccated Thyroid Tablets

March 1, 2019


Acella has NP Thyroid available.

Allergan has Armour Thyroid available.

RLC states the reason for the shortage is increased demand and difficulty obtaining raw materials.


RLC has Nature-Throid 16.25 mg, 194.4 mg, 260 mg, and 325 mg tablets on back order and the

company cannot estimate a release date. Westhroid presentations are also on back order and the

company cannot estimate a release date.


Dicyclomine Injection

March 1, 2019


Allergan has Bentyl injection available.

American Regent did not provide a reason for the shortage.

Hikma did not provide a reason for the shortage.

Nexus has dicyclomine injection for intramuscular use available.


Hikma has short-dated dicyclomine 10 mg/mL 2 mL vials available with an expiration date of May

2019.




Erythromycin Ophthalmic Ointment

March 1, 2019



Bausch Health did not provide a reason for the shortage.

Perrigo has erythromycin ophthalmic ointment on shortage due to increased demand.


Akorn has erythromycin 0.5% ophthalmic ointment in 3.5 gram tubes on allocation.

Bausch Health has erythromycin 0.5% ophthalmic ointment in 1 gram and 3.5 gram tubes on back

order and the company estimates a release date of mid-March 2019 for the 1 gram tubes and early-

to mid-April 2019 for the 3.5 gram tubes.

Perrigo has erythromycin 0.5% ophthalmic ointment in 1 gram tubes in 50 count and 3.5 gram tubes

in 24 count on back order and the company estimates a release date of April 2019 for the 1 gram

tubes and August 2019 for the 3.5 gram tubes.


Levetiracetam Immediate-Release Tablets

March 1, 2019


Accord has levetiracetam immediate-release tablets available.

Aurobindo has levetiracetam immediate-release tablets available.

Camber did not provide a reason for the shortage.


Major did not provide a reason for the shortage.


Torrent representatives were not available to provide information.

OWP representatives were not available to provide information on Roweepra availability.

UCB has Keppra immediate-release tablets available.


Camber has levetiracetam immediate-release tablets on intermittent back order and the company is

allocating product as it becomes available.

Lupin has levetiracetam immediate-release tablets on back order and the company estimates a

release date in first quarter 2019.

Major has levetiracetam immediate-release tablets on back order and the company cannot estimate

a release date.

Mylan has levetiracetam 250 mg and 1000 mg immediate-release tablets in all sizes on back order

and the company cannot estimate a release date. The 500 mg and 750 mg immediate-release tablets

in 120 and 500 count bottles are on back order and the company estimates a release date in mid-

April 2019. The 500 mg and 750 mg immediate-release tablets in 100 count unit dose packages are

on back order and the company estimates a release date of mid-March 2019 for the 500 mg tablets

and mid-May 2019 for the 750 mg tablets.




Lorazepam Injection

March 1, 2019


Bedford discontinued lorazepam injection in May, 2011.[1]

Hikma has product on shortage due to manufacturing delays.[2]

Pfizer has product on shortage due to increased demand and manufacturing delays. Pfizer

discontinued 4 mg/mL 10 mL vials in December 2017.[3]

Akorn has not provided a reason for the shortage.[4]

Amphastar has product available.[5]


Akorn has lorazepam 2 mg/mL 1 mL vials on allocation.[4]

Hikma has Ativan 2 mg/mL 1 mL vials on back order and the company estimates a release date of

March 2019.[2]

Pfizer has lorazepam 2 mg/mL 10 mL vials on back order and the company estimates a release date

of March 2019. The 2 mg/mL 1 mL Carpuject syringes and 4 mg/mL 1 mL vials are on back order and

the company estimates a release date of June 2019. The 4 mg/mL 1 mL Carpuject syringes are on

back order and the company estimates a release date of March 2020.[3]


Methocarbamol Tablets

March 1, 2019


Bayshore, Solco, Virtus, Hikma, and Endo did not provide a reason for the shortage.

Camber states the shortage is due to an API shortage.

Par discontinued methocarbamol tablets in July 2018.


Bayshore has all methocarbamol presentations on allocation.

Hikma has methocarbamol 500 mg and 750 mg tablets in 500 count on back order and the company

estimates a release date of March 2019. Methocarbamol 500 mg and 750 mg tablets in 100 count

are on back order and the company cannot estimate a release date.

Solco has all methocarbamol presentations on allocation.

Virtus has all methocarbamol tablets on back order and the company cannot estimate a release date.

Endo has Robaxin 750 mg tablets in 100 count on back order and the company cannot estimate a

release date.


Methylphenidate Extended-Release Oral Suspension and Chewable Tablets

March 1, 2019


Tris Pharma has Quillivant XR oral suspension and QuilliChew ER chewable tablets available.




Metoprolol Injection

March 1, 2019


Alvogen has metoprolol injection available.[1]

American Regent is not currently marketing metoprolol injection.[2]

Athenex has metoprolol injection available.[3]

Baxter did not provide a reason for the shortage.[4]

Fresenius Kabi has metoprolol injection on shortage due to increased demand.[5]

Mylan Institutional acquired metoprolol injection from Sagent. They discontinued metoprolol

injection in March 2018.[6]

Pfizer has metoprolol injection on shortage due to manufacturing delays.[7]

Hikma did not provide a reason for the shortage.[8]


Baxter (formerly Claris) has metoprolol 1 mg/mL 5 mL vials on back order and the company

estimates a release date of April 2019.[4]

Fresenius Kabi has metoprolol 1 mg/mL 5 mL vials on back order and the company estimates a

release date of mid- to late-March 2019.[5]

Hikma has metoprolol 1 mg/mL 5 mL and 10 mL vials on back order and the company estimates a

release date of March to April 2019.[8]

Pfizer has metoprolol 1 mg/mL 5 mL Carpuject syringes on back order and the company estimates a

release date of 1st quarter 2020. The 1 mg/mL 5 mL ampules are on back order and the company

estimates a release date of December 2019. The 1 mg/mL 5 mL vials are on back order and the

company estimates a release date of April 2019.[7]


Recombinant Zoster Vaccine (Shingrix)

March 1, 2019


GlaxoSmithKline has Shingrix on shortage due to high demand for the product.


GlaxoSmithKline has Shingrix on intermittent back order and the company is shipping orders

according to order date and supply available.


Scopolamine Transdermal System

March 1, 2019


Baxter did not provide a reason for the shortage.

GlaxoSmithKline states the shortage was due to increased demand.

Perrigo did not provide a reason for the shortage.




Baxter has Transderm Scop 1.5 mg patches in 10 and 24 count on back order and the company

cannot estimate release dates.

Perrigo has scopolamine patches on back order and the company cannot estimate a release date.


Sodium Polystyrene Sulfonate Powder

March 1, 2019


CMP Pharma has sodium polystyrene sulfonate on back order due to a raw material shortage.

ECI Pharmaceuticals did not provide a reason for the shortage.

KVK-Tech did not provide a reason for the shortage.

Sunrise Pharmaceuticals has sodium polystyrene sulfonate on back order due to a raw material

shortage.

Trigen did not provide a reason for the shortage.


CMP Pharma has sodium polystyrene sulfonate in 454 gram bottles on back order and the company

cannot estimate a release date.

ECI Pharmaceuticals has sodium polystyrene sulfonate in 454 gram bottles on back order and the

company estimates a release date of early-April 2019.

KVK-Tech has sodium polystyrene sulfonate in 454 gram bottles on back order and the company

estimates a release date of late-March 2019.

Sunrise Pharmaceuticals has sodium polystyrene sulfonate in 15 gram and 454 gram bottles on

intermittent back order and the company cannot estimate release dates.

Trigen has sodium polystyrene sulfonate in 454 gram bottles on allocation.


Spironolactone Tablets

March 1, 2019


Accord, Amneal, Cadista, Mylan, and Sun Pharma did not provide a reason for the shortage.

Par discontinued spironolactone tablets in August 2018.

Pfizer states Aldactone is on shortage due to manufacturing delays.


Accord has spironolactone 50 mg tablets in 500 count bottles and 100 mg tablets in 500 count

bottles on back order and the company estimates a release date of mid-March 2019.

Amneal has all spironolactone presentations on back order and the company cannot estimate a

release date.

Mylan has spironolactone 50 mg tablets in 100 and 500 count bottles and 100 mg tablets in 100

count bottles are on back order and the company estimates release dates of mid-March 2019 for the

50 mg tablets in 100 count and 500 count bottles and early-March 2019 for the 100 mg tablets in 100



count bottles. The 25 mg tablets in 100 count bottles are on back order and the company estimates a

release date of early-March 2019.

Par has most presentations on back order and the company cannot estimate a release date.

Pfizer has Aldactone 25 mg tablets in 100 count bottles and 50 mg tablets in 100 count bottles on

back order and the company estimates a release date of March 2019.

Sun Pharma has spironolactone 25 mg tablets in 100 and 1000 count, 50 mg tablets in 60 and 500

count, and 100 mg in 100 count on back order and the company cannot estimate a release date.


Sterile Water for Injection - Small Volume Vials

March 1, 2019


American Regent has sterile water for injection available.

Fresenius Kabi has sterile water on shortage due to increased demand.

Hikma has sterile water for injection available.

Pfizer has sterile water for injection in vials on shortage due to increased demand.


Fresenius Kabi has sterile water for injection 100 mL vials on back order and the company cannot

estimate a release date. Check wholesalers for inventory.

Pfizer has sterile water for injection 50 mL vials on back order and the company estimates a release

date of March 2019. The 20 mL and 100 mL vials are available in limited supply.


Dobutamine Injection

March 4, 2019


Baxter has dobutamine available.

Pfizer has dobutamine on shortage due to manufacturing delays.


Pfizer has dobutamine 12.5 mg/mL 20 mL and 40 mL latex-free vials on back order with an estimated

release date of March 2020 for the 20 mL vials and December 2019 for the 40 mL vials.

Pfizer has dobutamine 1 mg/mL in 250 mL bags on back order and the company estimates a release

date of June 2019. The dobutamine 4 mg/mL 250 mL bags are available in limited supply.


Enalaprilat Injection

March 4, 2019



Pfizer has enalaprilat injection on shortage due to manufacturing delays.


Hikma has enalaprilat 1.25 mg/mL 1 mL and 2 mL vials on allocation.



Pfizer has enalaprilat 1.25 mg/mL 1 mL and 2 mL vials on back order and the company estimates a

release date of March 2020.


Epinephrine Injection

March 4, 2019


Amphastar stopped distributing epinephrine 1 mg/mL 30 mL vials on May 10, 2017. They are

continuing to supply 0.1 mg/mL 10 mL syringes. These are on shortage due to increased demand.[1]

Pfizer stopped distributing epinephrine 1 mg/mL presentations on May 10, 2017.[2]

BPI has epinephrine 1 mg/mL 2 mL ampules available.[3]

Par has Adrenalin 1 mg/mL 1 mL and 30 mL vials available.[4]


Amphastar has epinephrine 0.1 mg/mL 10 mL syringes on allocation.[1]

Pfizer has epinephrine 0.1 mg/mL 10 mL syringes on back order and the company estimates a release

date of March 2019.[2]

Snap Medical Industries has the Epinephrine Snap-V Kit available. Each kit contains an epinephrine 1

mg/mL 1 mL vial, (3) 1 mL luer lock syringes, and (3) 23-gauge 1-inch needles.


Furosemide Tablets

March 4, 2019


Major discontinued furosemide tablets in early-2018.


Hikma states the shortage is due to manufacturing delays.

Sandoz discontinued furosemide tablets in late-August 2017.

Teva discontinued furosemide tablets in June 2018


Hikma has furosemide 20 mg tablets in 100 count unit dose packs, 40 mg tablets in 100 count unit

dose packs, 40 mg tablets in 100 count bottles, 40 mg tablets in 1000 count bottles, and 80 mg

tablets in 100 count unit dose packs on allocation.

Mylan has furosemide 40 mg tablets in 1000 count on back order and the company estimates a

release date of late-March 2019.


Mycophenolate Mofetil Capsules and Tablets

March 4, 2019


Accord did not provide a reason for the shortage.

Ascend did not provide a reason for the shortage.





Genentech has Cellcept available.

Sandoz did not provide a reason for the shortage.


Accord has all mycophenolate mofetil presentations on allocation.

Ascend has all mycophenolate mofetil presentations on intermittent back order and the company is

releasing product as it becomes available.

Hikma has mycophenolate mofetil 250 mg capsules in 100 count and 500 count and 500 mg tablets

in 100 count and 500 count on allocation.

Mylan has mycophenolate mofetil 250 mg capsules in 500 count on back order and the company

estimates a release date of late-March 2019. The 500 mg tablets in 500 count are on back order and

the company estimates a release date of mid-April 2019.

Sandoz has mycophenolate mofetil 250 mg capsules in 1440 count are on back order and the



Phenytoin Sodium Injection

March 4, 2019


Hikma did not provide a reason for this shortage.

X-Gen Pharmaceuticals discontinued their phenytoin sodium presentations in April 2017.


Hikma has phenytoin sodium 50 mg/mL 2 mL and 5 mL vials available.


Sodium Bicarbonate Injection

March 4, 2019


Amphastar has sodium bicarbonate injection available.[1]

Pfizer has sodium bicarbonate injection on shortage due to manufacturing delays.[2]

Fresenius Kabi had sodium bicarbonate injection temporarily available, but have run out of stock,

there is more in production at this time.[3]


Fresenius Kabi has 8.4% sodium bicarbonate 50 mL vials on back order and the company estimates a

release date of mid- to late-March 2019.[3]

Pfizer has sodium bicarbonate 4.2% 10 mL LifeShield syringes and 7.5% 50 mL syringes available in

limited supply. The 8.4% 10 mL syringes are on back order and the company estimates a release date

of March 2019. The 8.4% 50 mL vials are on back order and the company estimates a release date of

March 2019. The 8.4% 50 mL syringes are on back order and the company estimates a release date

of April 2019.[2]

Pfizer has Neut 4% 5 mL vials on back order and the company estimates a release date of May

2019.[2]




Sodium Phosphate Injection

March 4, 2019


American Regent is not currently marketing sodium phosphate injection.[1]

Fresenius Kabi states the reason for the shortage is increased demand.[2]

Pfizer has sodium phosphate injection on shortage due to manufacturing delay.[3]


Fresenius Kabi has sodium phosphate 3 mmol/mL 5 mL and 15 mL vials on back order and the

company estimates a release date of mid- to late-March 2019.[2]

Pfizer has sodium phosphate 3 mmol/mL 15 mL vials on back order and the company estimates a

release date of March 2020.[3]


Thrombin Topical Solution (Bovine)

March 4, 2019


Pfizer has Thrombin-JMI on shortage due to manufacturing delays.

Recombinant thrombin is not affected by this shortage.


Pfizer has Thrombin-JMI 20,000 unit syringe spray kits on back order and the company estimates a

release date of March 2019. The 5,000 unit epistaxis kits are on back order and the company

estimates a release date of July 2019. The 20,000 unit pump spray kits are on back order and the

company estimates a release date of March 2020. The 5,000 unit vials are available in limited supply.

The 5,000 unit syringe spray kits are on back order and the company estimates a release date of

March 2019.


Atropine Sulfate Injection

March 5, 2019


American Regent had atropine injection on shortage due to market demand.

Amphastar has atropine injection available.

Fresenius Kabi has atropine injection available.

Hikma has atropine injection available.

Pfizer has atropine injection on shortage due to manufacturing delays.


American Regent has atropine 1 mg/mL 1 mL vials available in limited supply.

Pfizer has atropine 0.1 mg/mL 10 mL LifeShield syringes on back order and the company estimates

release dates of March 2019. The 0.1 mg/mL 10 mL Ansyr syringes are on back order and the

company estimates a release date of April 2019. The 0.1 mg/mL 5 mL LifeShield syringes are on back



order and the company estimates release dates of July 2019. The 0.05 mg/mL 5 mL Ansyr syringes

are available with an expiration date of May 2019.


Cidofovir Injection

March 5, 2019


Heritage has cidofovir available.

Mylan Institutional did not provide a reason for the shortage.


Mylan Institutional has cidofovir 75 mg/mL 5 mL vials on back order and the company estimates a

release date of mid-May 2019.


Clotrimazole Lozenges (Clotrimazole Troches)

March 5, 2019



Perrigo has clotrimazole lozenges on shortage due to increased demand.


Hikma has clotrimazole 10 mg lozenges in 70 count and 140 count bottles on allocation. The 10 mg

lozenges in 70 count unit-dose packs are on back order and the company estimates a release date of

early-March 2019.

Perrigo has clotrimazole 10 mg lozenges in 70 count and 140 count bottles on back order and the

company estimates a release date of late-March 2019 for the 70 count bottles and August 2019 for

the 140 count bottles. The 10 mg lozenges in 70 count unit-dose packs are on back order and the

company estimates a release date of August 2019.


Diclofenac 0.1% Ophthalmic Solution

March 5, 2019


Akorn discontinued diclofenac ophthalmic solution.

Rising pharmaceuticals discontinued diclofenac ophthalmic solution.

Sandoz has diclofenac available.


All marketed presentations are available.




Hydralazine injection

March 5, 2019


Akorn has product on back order due to increased demand.

American Regent is not currently marketing hydralazine injection.


X-Gen did not provide a reason for the shortage.


Akorn has hydralazine 20 mg/mL 1 mL vials on allocation.

Fresenius Kabi has hydralazine 20 mg/mL 1 mL vials on back order and the company estimates a

release date of mid-March 2019. Check wholesalers for inventory.

X-Gen has hydralazine 20 mg/mL 1 mL vials on intermittent back order and the company is releasing

product as it becomes available.


Hydroxyprogesterone Caproate Injection

March 5, 2019


AMAG has Makena vials on shortage due to manufacturing delay.

American Regent has hydroxyprogesterone injection available.

Mylan has hydroxyprogesterone injection available.

Prasco has hydroxyprogesterone injection available.

Slayback Pharma launched hydroxyprogesterone injection in January 2019.


AMAG has Makena 250 mg/mL 1 mL and 5 mL vials on back order and the company estimates cannot



Hypromellose Ophthalmic Solution

March 5, 2019


Akorn has hypromellose ophthalmic solution on shortage due to lack of raw materials.1

HUB Pharmaceuticals has hypromellose ophthalmic solution on long-term back order and did not

provide a reason.2

Altaire did not provide a reason for the shortage.[3]


Akorn has Gonak 2.5% ophthalmic solution 15 mL bottles on back order and the company cannot

estimate a release date.1

HUB Pharmaceuticals has Goniovisc 2.5% ophthalmic solution 15 mL bottles on long-term back order

and the company cannot estimate a release date.2

Ocusoft has Goniosoft 2.5% ophthalmic solution 15 mL bottles on back order and the company

cannot estimate a release date.[4]



Altaire has Goniotaire on back order and the company cannot estimate a release date.[3]


Promethazine Injection

March 5, 2019



X-Gen has promethazine injection available.


Hikma has promethazine 25 mg/mL 1 mL ampules on back order and the company estimates a

release date of mid- to late-March 2019. The 50 mg/mL 1 mL ampules are on back order and the

company estimates a release date of mid- to late-March 2019.

Hikma has short-dated Phenergan 50 mg/mL 1 mL ampules available with an expiration date of

August 2019.


Thiothixene Capsules

March 5, 2019



Mylan is the sole supplier of thiothixene.


Mylan has thiothixene 1 mg, 2 mg, 5 mg, and 10 mg capsules in 100 count bottles on back order and

the company estimates a release date of mid-April 2019 for the 1 mg and 5 mg capsules and mid- to

late-March 2019 for the 2 mg and 10 mg capsules.

Mylan Institutional has thiothixene 2 mg, 5 mg, and 10 mg capsules in 100 count unit-dose blister

packs on back order and the company estimates a release date of late-April to early-May 2019 for

the 2 mg and 10 mg capsules and mid- to late-May 2019 for the 5 mg capsules.


Trifluoperazine Tablets

March 5, 2019



Upsher-Smith did not provide a reason for the shortage.


Mylan has trifluoperazine 1 mg, 2 mg, 5 mg, and 10 mg tablets in 100 count bottles on back order

and the company estimates a release date of early-May 2019 for the 1 mg and 5 mg tablets and

early-April 2019 for the 2 mg and 10 mg tablets. The 1 mg, 2 mg, 5 mg, and 10 mg tablets in 100

count unit-dose packs are on back order and the company estimates a release date of early-June

2019 for the 1 mg and 5 mg tablets and mid-May 2019 for the 2 mg and 10 mg tablets.



Upsher-Smith has trifluoperazine 1 mg, 2 mg, 5 mg, and 10 mg tablets in 100 count bottles on long-

term back order and the company cannot estimate a release date.


0.9% Sodium Chloride 10 mL, 20 mL, and 50 mL Preservative Free Vials and Syringes

March 6, 2019


Fresenius Kabi has recalled multiple lots of 0.9% sodium chloride 10 mL and 20 mL vials due to labels

incorrectly stating the stoppers are latex-free. The letter and the lot numbers affected can be found

at https://www.fresenius-kabi.com/us/news/fresenius-kabi-issues-voluntary-nationwide-recall-of-

sodium.

Pfizer has 0.9% sodium chloride preservative-free vials on shortage due to manufacturing delays.


Pfizer has 0.9% sodium chloride preservative free 20 mL and 50 mL vials on back order and the

company estimates a release date of April 2019 for the 20 mL vials and March 2019 for the 50 mL

vials. The 10 mL LifeShield syringes are on back order and the company estimates a release date of

March 2019.


Alpha-1 Proteinase Inhibitor

March 6, 2019


CSL Behring states Zemaira is available.

The other alpha-1 proteinase inhibitors such as Aralast and Prolastin-C are not affected by this

shortage.


CSL Behring has Zemaira 1 mg vials available.


Asparaginase Erwinia chrysanthemi

March 6, 2019


Jazz Pharmaceuticals has Erwinaze available.


Jazz Pharmaceuticals has Erwinaze 10,000 unit vials in 1 count and 5 count available. There is a new

process for ordering Erwinaze. Additional information regarding the new ordering process is

available at www.erwinazesupply.com.




Dexmedetomidine Hydrochloride 4 mcg/mL Premix for Injection

March 6, 2019


Pfizer did not provide a reason for the shortage.

WG Critical Care began marketing premixed bags in November 2018.

Baxter has dexmedetomidine premixed bags available.


Pfizer has Precedex 4 mcg/mL 20 mL glass vials and 4 mcg/mL 50 mL and 100 mL premixed bottles

available in limited supply.


Fentanyl Citrate Injection

March 6, 2019


Akorn has fentanyl injection on shortage due to increased demand. They are not currently marketing

25 count fentanyl ampules.

Hikma has fentanyl injection on shortage due to supply and demand issues. They are not currently

marketing fentanyl ampules, just vials.

Pfizer has fentanyl injection on shortage due to manufacturing delays. The 20 mL ampules were

discontinued in September 2017.


Pfizer has fentanyl 50 mcg/mL 2 mL and 20 mL vials on back order and the company estimates a

release date of March 2019. The 2 mL Carpuject syringes are on back order and the company

estimates a release date of December 2019. The 50 mL vials are available in limited supply and the

company estimates a release date of April 2019.


Haloperidol Tablets

March 6, 2019



Sandoz has discontinued haloperidol 0.5 mg and 1 mg tablets.


Mylan has haloperidol 0.5 mg and 1 mg tablets in 100 count unit-dose packs on back order and the

company estimates a release date of early-May 2019. The 2 mg and 5 mg tablets are on back order

and the company estimates a release date of mid-May 2019. The 10 mg tablets in 100 count unit-

dose packs are on back order and the company estimates a release date of early-June 2019. The 0.5

mg tablets in 100 count and 1000 count, 1 mg tablets in 100 count and 1000 count, 2 mg tablets in

100 count and 1000 count, and 5 mg tablets in 100 count and 1000 count are on back order and the

company estimates a release date of mid-April 2019. The 10 mg tablets in 100 count and 20 mg

tablets in 100 count are on back order and the company estimates a release date of mid-May 2019.

Zydus has all haloperidol tablet presentations on allocation.




Hydroxyethyl Starch in Sodium Chloride Injection

March 6, 2019


BBraun did not provide a reason for the shortage of Hespan.

Pfizer has 6% hetastarch in 0.9% sodium chloride injection available.

Pfizer has Voluven available.


BBraun has Hespan injection on intermittent back order and the company is releasing supplies as

they become available.


Metronidazole Hydrochloride Injection

March 6, 2019


Pfizer has metronidazole injection on shortage due to manufacturing delay.

BBraun has metronidazole injection available.


Baxter has metronidazole 100 mL bags (NDC 36000-0001-24) on back order and the company cannot


Pfizer has metronidazole 100 mL bags in 24 count on back order and the company estimates a



Mineral Oil and Petrolatum Ophthalmic Ointment

March 6, 2019


Allergan states the shortage is due to production delays.

Bausch Health has Soothe Night Time ointment available.

Major did not provide a reason for the shortage.

Alcon states the shortage is due to manufacturing issues.

Perrigo discontinued Puralube ointment products in early-2019.

Rugby did not provide a reason for the shortage.


Allergan has Refresh PM and Lacri-Lube SOP ointment 3.5 gram tubes on back order and the

company cannot estimate a release date. Lacri-Lube SOP 7 gram tubes are also on back order and


Rugby has Artificial Tears 3.5 gram tubes on back order and the company cannot estimate a release

date.



Alcon has Systane Nighttime ointment and Genteal PM ointment on back order and the company

estimates a release date in early-April 2019 for Systane Nighttime ointment and mid-April 2019 for

Genteal PM ointment.


Nelfinavir Mesylate Tablets

March 6, 2019


Viiv Healthcare states the shortage is due to a manufacturing issue.

Viiv Healthcare is the sole supplier of nelfinavir.


Viiv Healthcare has Viracept tablets on back order and the company cannot estimate a release date.


Potassium Chloride Injection

March 6, 2019


Baxter had their highly concentrated potassium chloride in sterile water on shortage because a

manufacturing facility was affected by Hurricane Maria. Baxter did not provide a reason for the

shortage of their other potassium chloride products.


Pfizer has potassium chloride injection on shortage due to increase demand. Pfizer discontinued 2

mEq/mL 250 mL bottles in mid-2018.

ICU Medical has potassium chloride injection on shortage due to increased demand.

ICU Medical discontinued potassium chloride 10 mEq/500 mL in 5% dextrose and 0.225% sodium

chloride in 2018.


Fresenius Kabi has potassium chloride 10 mEq/5 mL vials on back order and the company estimates a

release date in mid- to late-March 2019.

ICU Medical has all potassium chloride injection presentations available to current customers.


Sincalide Injection

March 6, 2019


Bracco Diagnostics has Kinevac injection on shortage due to a supply disruption.

There are no approved alternatives to Kinevac for the labeled indications.


Bracco has Kinevac on backorder and the company cannot estimate a release date.




Heparin Sodium Premixed Bags

March 7, 2019


Baxter has heparin on shortage due to manufacturing delays.

Braun has heparin premixes available.

Fresenius Kabi has heparin premixes available.

Pfizer has heparin on shortage due to manufacturing delays.


Baxter has heparin 2000 units/1,000 mL premixed bags on back order and the company cannot


Pfizer has heparin 2,000 units/1,000 mL 0.9% sodium chloride premixed bags on back order and the

company estimates a release date of March 2019. The 25,000 units/250 mL 0.45% sodium chloride

premixed bags and 25,000 units/250 mL 5% dextrose premixed bags are on back order and the

company estimates a release date of March 2019. Heparin 1,000 units/500 mL 0.9% sodium chloride

premixed bags are available in limited supply.


Indomethacin Capsules

March 7, 2019


Camber did not provide a reason for the shortage.

Glenmark has indomethacin on shortage due to manufacturing delays.

Heritage discontinued all indomethacin presentations in early-2018.

Mylan did not provide a reason for the shortage. Mylan is in the process of discontinuing all

presentations.

Sandoz discontinued indomethacin in mid-2016.

Teva discontinued all indomethacin presentations in mid-2018.


Camber has indomethacin 25 mg and 50 mg capsules on intermittent back order and the company is

releasing product weekly.

Glenmark has indomethacin 25 mg capsules in 100 count and 1,000 count and 50 mg capsules in 100

count and 500 count on back order and the company estimates a release date of late-April to early-

May 2019.


Methyldopa Tablets

March 7, 2019








Accord has temporarily discontinued all methyldopa tablet presentations.

Teva has methyldopa 500 mg tablets temporarily unavailable with no estimated release date.

Mylan has methyldopa 250 mg tablets and 500 mg tablets in 100 count bottles on back order and the

company estimates a release date of early-October 2019. The 250 mg tablets and 500 mg tablets in

100 count unit-dose packs are on back order and the company estimates a release date of late-

October to early-November 2019.


Octreotide Injection

March 7, 2019


Fresenius Kabi has octreotide available.



Sagent has octreotide on shortage due to increased demand.

Sun Pharma is not currently marketing octreotide.


Novartis has Sandostatin available. The 200 mcg/mL 5 mL vials were discontinued in early-2018.


Hikma has octreotide 1000 mcg/mL 5 mL vials on back order and the company estimates a release

date of March 2019. The 100 mcg/mL 1 mL vials, 500 mcg/mL 1 mL vials, and 200 mcg/mL 5 mL vials

are available with a short expiration date of March 2019.

Mylan has octreotide 100 mcg/mL 1 mL syringe on back order and the company estimates a release

date in early-April 2019.

Novartis has Sandostatin 50 mcg/mL 1 mL ampules available with short expiration dating (September

2019).

Sagent has ocreotide 50 mcg/mL 1 mL vials on back order and the company cannot estimate a

release date. The 100 mcg/mL 1 mL vials are on back order and the company estimates a release

date in June 2019.

Teva has octreotide 100 mcg/mL 1 mL vials on intermittent back order and the company is allocating



Orphenadrine Citrate Injection

March 7, 2019




Teva discontinued orphenadrine in November 2018.


Akorn has orphenadrine 30 mg/mL 2 mL vials on back order and the company estimates a release

date of March 2019.



Hikma has orphenadrine 30 mg/mL 2 mL vials on allocation.


0.9% Sodium Chloride Large Volume Bags

March 7, 2019


Baxter discontinued 0.9% sodium chloride 250 mL and 500 mL AVIVA bags. The Viaflex bags and

Viaflo bags are available.[1]

BBraun did not provide a reason for the shortage.[2]

BD has 0.9% sodium chloride bags for injection available.[3]

ICU Medical cited increased demand as the reason for the shortage.[4]

Fresenius Kabi has 0.9% sodium chloride bags for injection available.[9]

Baxter has received FDA approval for 0.9% sodium chloride in Viaflo containers manufactured in an

FDA-approved facility in Spain. Additional information about this product is available at:

http://www.baxter.com/information/saline_supply.html.


ICU Medical has all 0.9% sodium chloride bags readily available except the 0.9% sodium chloride 250

mL 2-port bags are available to current customers only. [4]


0.9% Sodium Chloride Small Volume Bags (< 150 mL)

March 7, 2019


Baxter did not provide a reason for the 0.9% sodium chloride small volume bags shortage. Most

presentations are available.

BBraun has 0.9% sodium chloride small volume bags available.

BD has 0.9% sodium chloride small volume bags available.

Fresenius Kabi has 0.9% sodium chloride small volume bags available.

ICU Medical has 0.9% sodium chloride small volume bags on shortage due to increased demand.

Pfizer has 0.9% sodium chloride small volume presentations on shortage due to increased demand.


ICU Medical has 0.9% sodium chloride 100 mL VisIV bags on allocation to current customers.

Pfizer has 0.9% sodium chloride 50 mL preservative-free vials on back order and the company

estimates a release date of March 2019.


14.6% Sodium Chloride Concentrated Solution for Injection

March 7, 2019


Pfizer has 14.6% sodium chloride concentrated solution for injection on shortage due to

manufacturing delays.




Pfizer has 14.6% sodium chloride concentrated solution for injection 20 mL and 40 mL vials on back

order and the company estimates a release date of March 2020 for the 20 mL vials and April 2019 for

the 40 mL vials.

Fresenius Kabi has 14.6% sodium chloride concentrated solution for injection 40 mL vials on back

order and the company cannot estimate a release date.


2% Lidocaine Hydrochloride Topical Jelly

March 7, 2019


Akorn has 2% lidocaine jelly on shortage due to increased demand.

Teva discontinued lidocaine jelly in early-2018.

Glydo and Uro-Jet prefilled syringes are not affected by this shortage.


Akorn has 2% lidocaine jelly 5 mL and 30 mL tubes on allocation.


25% Dextrose Injection

March 7, 2019


Pfizer has 25% dextrose on shortage due to manufacturing delays.


Pfizer has 25% dextrose 10 mL Ansyr syringes on back order and the company estimates a release

date of April 2019.


5% Dextrose Injection (PVC-free and DEHP-free)

March 7, 2019


Baxter is not currently marketing 5% dextrose PVC/DEHP-free bags.

BBraun had 5% dextrose PVC/DEHP-free bags on shortage due to manufacturing delays.

BD has 5% dextrose PVC/DEHP-free bags available.

Fresenius Kabi has 5% dextrose PVC/DEHP-free bags available.

ICU Medical has 5% dextrose PVC/DEHP-free bags due to manufacturing delays.


ICU Medical has 5% dextose PVC/DEHP-free 50 mL and 250 mL bags on allocation to contracted

customers only.




50% Dextrose Injection

March 7, 2019


Amphastar has 50% dextrose injection on allocation due to increased demand.

Pfizer has 50% dextrose injection on shortage due to manufacturing delays.


Pfizer has 50% dextrose 50 mL LifeShield syringes on back order and the company estimates a

release date of June 2019. The 50% dextrose 50 mL Ansyr syringes are on back order and the

company estimates a release date of April 2019. The 50% dextrose 50 mL vials are on back order and

the company estimates a release date of May 2019.

Amphastar has 50% dextrose 50 mL Luer-Jet syringes on allocation with regular releases.


Ascorbic Acid Injection

March 7, 2019




Mylan Institutional has ascorbic acid 500 mg/mL 50 mL vials on back order and the company

estimates a release date of mid-March 2019.


Azithromycin Injection

March 7, 2019


AuroMedics did not provide a reason for the shortage.

Fresenius Kabi has azithromycin injection on shortage due to increased demand.

Pfizer has azithromycin injection on shortage due to manufacturing delays.

Sun Pharma is not currently manufacturing azithromycin injection.


AuroMedics has azithromycin 500 mg vials on intermittent back order and the company is releasing


Fresenius Kabi has azithromycin 500 mg vials on back order and the company estimates a release

date of mid- to late-March 2019.

Pfizer has azithromycin 500 mg ADD-Vantage vials on back order and the company estimates a

release date of March 2020. Zithromax 500 mg vials are on back order and the company estimates a





Cefoxitin Sodium Injection

March 7, 2019


Apotex did not provide a reason for the shortage.

BBraun has cefoxitin on allocation due to increased demand.


Hikma did not provide a reason for the shortage. Hikma is not currently marketing cefoxitin.

Sagent has cefoxitin on shortage due to increased demand and manufacturing delay.

WG Critical Care did not provide a reason for the shortage.


Apotex has temporarily discontinued cefoxitin 1 gram, 2 gram, and 10 gram vials and the company

cannot estimate when product will be available again.

BBraun has cefoxitin 1 gram and 2 gram DUPLEX bags on back order and the company cannot

estimate a next release date.

Fresenius Kabi has cefoxitin 1 gram and 2 gram vials on back order and the company estimates a

release date of mid-May 2019 for the 1 gram vials and mid-March 2019 for the 2 gram vials.

Sagent has cefoxitin 1 gram and 2 gram vials on back order and the company estimates a release

date of March 2019. The 10 gram vials are on back order and the company estimates a release date

of April 2019.

WG Critical Care has cefoxitin 2 gram vials on back order and the company estimates a release date

of March 2019. The 1 gram vials are on back order and the company estimates a release date of April

2019. The 10 gram vials are on back order and the company cannot estimate a release date.


Fluticasone and Salmeterol Powder for Inhalation

March 7, 2019


Teva Respiratory did not provide a reason for the shortage.

Other fluticasone and salmeterol dry powder inhalers are not affected by the shortage.


Teva Respiratory has AirDuo Respiclick 113 mcg/14 mcg and 232 mcg/14 mcg dry powder inhalers on

back order and the company estimates a release date of early-April 2019.

Teva Respiratory has fluticasone and salmeterol 113 mcg/14 mcg and 232 mcg/14 mcg dry powder

inhalers on back order and the company estimates a release date of late-March 2019.


Amiodarone Injection

March 8, 2019


Baxter has Nexterone premixed bags on shortage due to manufacturing delays.




Hikma did not provide a reason for the shortage; however, the 50 mg/mL, 3 mL 10 count

presentation was discontinued in December 2018.


AuroMedics has amiodarone 50 mg/mL 3 mL, 9 mL, and 18 mL vials on intermittent back order and

the company is releasing product as it becomes available.

Baxter has Nexterone 150 mg/100mL and 360 mg/200mL premixed bags on allocation.

Fresenius Kabi has amiodarone 50 mg/mL 3 mL vials on back order and the company estimates a

release date of mid-March 2019. There are short-dated 4 mL vials available with an expiration date

of <3 months.

Mylan Institutional has amiodarone 50 mg/mL 3 mL vials on back order and the company estimates a

release date of mid-March 2019. The 9 mL vials are on back order and the company cannot estimate

a release date.

Sagent has amiodarone 50 mg/mL 3 mL vials available with a short expiry of February 2019.


Ceftriaxone Sodium Injection

March 8, 2019


Apotex has ceftriaxone available.

Fresenius Kabi states the reason for the shortage was increased demand.

Pfizer had ceftriaxone injection on shortage due to increased demand and manufacturing delays.

Sagent states the reason for the shortage is manufacturing delay.

Sandoz has ceftriaxone available.

Hikma states the reason for the shortage is manufacturing delay.

Wockhardt has discontinued their ceftriaxone presentations.


Baxter has ceftriaxone premixed bags on back order and the company cannot estimate a release

date.

Lupin has all ceftriaxone presentations on allocation.

Hikma has ceftriaxone 250 mg and 500 mg vials on back order and the company cannot estimate a

release date. The 1 gram and 2 gram vials are on back order and the company estimates a release

date of mid-March 2019.

Sagent has ceftriaxone 1 gram vials on back order and the company estimates a release date in April

2019. There are short-dated 500 mg vials available with an expiration date of April 2019.


Cyclosporine Capsules

March 8, 2019


Apotex has cyclosporine capsules available.

Sandoz has discontinued cyclosporine (modified) capsules.




Teva has cyclosporine 25 mg, 50 mg, and 100 mg capsules on intermittent back order and the

company is releasing product as it becomes available.


Immune Globulin, Intravenous or Subcutaneous (Human)

March 8, 2019


Grifols has Gamunex-C on shortage due to increased market demand.

Takeda has Gammagard Liquid on shortage due to increased demand.


Grifols has all Gamunex-C presentations on intermittent back order and the company is releasing


Takeda has all Gammagard Liquid presentations on intermittent back order and the company is

releasing product as it becomes available.


Piperacillin and Tazobactam Injection

March 8, 2019


Apotex has piperacillin/tazobactam injection available.

AuroMedics has piperacillin/tazobactam injection available.

Baxter has piperacillin/tazobactam injection available.

Fresenius Kabi has piperacillin/tazobactam injection available.


Pfizer has Zosyn single dose vials and piperacillin/tazobactam on shortage due to manufacturing

delays.

Sagent has piperacillin/tazobactam injection on shortage due to increased demand.

Sandoz has piperacillin/tazobactam injection available.

WG Critical Care has piperacillin/tazobactam injection available.

Wockhardt has piperacillin/tazobactam injection available.

X-Gen has piperacillin/tazobactam injection available.


Mylan has piperacillin/tazobactam 4.5 gram vials on back order and the company estimates a release

date of mid-May 2019.

Pfizer has Zosyn 2.25 gram vials, 3.375 gram vials, 4.5 gram vials, and 40.5 gram vials on back order

and the company estimates a release date of March 2020. The piperacillin/tazobactam 2.25 gram

ADD-Vantage vials are on back order and the company estimates a release date of July 2019. The

3.375 gram vials are available in limited supply.

Sagent has piperacillin/tazobactam 3.375 gram and 4.5 gram vials on back order and the company

estimates a release date of April 2019. There are short-dated 2.25 gram vials available with an

expiration date of October 2019.




Thiamine Injection

March 8, 2019


Fresenius Kabi has thiamine injection on shortage due to short manufacturing delay.

Mylan Institutional has thiamine injection available.


Fresenius Kabi has thiamine 100 mg/mL 2 mL vials on back order and the company estimates a

release date of late-March 2019.

Mylan Institutional has thiamine 100 mg/mL 2 mL vials on back order and the company estimates a

release date of mid-March 2019.


Tobramycin Sulfate Injection

March 8, 2019


Akorn discontinued tobramycin injection in late-2018.

Pfizer had tobramycin injection on shortage due to manufacturing delays.

Teva discontinued tobramycin 40 mg/mL 30 mL vials in June 2018.


Baxter (formerly Claris) has tobramycin 40 mg/mL 2 mL and 30 mL vials on back order and the


Mylan Institutional has tobramycin 40 mg/mL 2 mL and 30 mL vials on back order and the company

estimates a release date of mid-April 2019.

Pfizer has tobramycin 40 mg/mL 2 mL vials available in limited supply.

Teva has temporarily discontinued tobramycin 40 mg/mL 2 mL vials.


Amphotericin B Injection

March 11, 2019


X-Gen has amphotericin B on shortage due to manufacturing delays. They are the sole suppliers of

amphotericin B lyophilized powder for injection.[1]

Lipid-based amphotericin is not affected by this shortage.


X-Gen has amphotericin B 50 mg vials on back order and the company estimates a release date of

mid-April 2019.[1]




Benztropine Mesylate Injection

March 11, 2019






Akorn has benztropine 1 mg/mL 2 mL ampules and Cogentin 1 mg/mL 2 mL ampules on back order

and the company cannot estimate a release date.

Fresenius Kabi has benztropine 1 mg/mL 2 mL vials on back order and the company estimates a

release date of mid- to late-March 2019.


Betamethasone Acetate/Betamethasone Sodium Phosphate Suspension for Injection

March 11, 2019


American Regent has betamethasone acetate/betamethasone sodium phosphate on shortage due to

minor shipping delays.

Merck did not provide a reason for the shortage.

Exela Pharma Sciences has betamethasone acetate/betamethasone sodium phosphate on shortage

due to increased demand.


American Regent has betamethasone acetate/betamethasone sodium phosphate 6 mg/mL 5 mL vials

available in limited supply.

Exela has betamethasone acetate/betamethasone sodium phosphate 6 mg/mL 5 mL vials on back

order and the company estimates a release date of early- to mid-April 2019.

Merck has Celestone Soluspan 5 mL vials on back order and the company estimates a release date of

April 2019.


Bupivacaine with Epinephrine Injection

March 11, 2019


Fresenius Kabi has bupivacaine and epinephrine on shortage due to increased demand and

manufacturing delays.

Pfizer has bupivacaine with epinephrine on shortage due to manufacturing delays.


Fresenius Kabi has 0.25% Sensorcaine-MPF with epinephrine 10 mL vials on back order and the

company estimates a release date of late-March 2019. The 0.25% Sensorcaine-MPF with epinephrine

30 mL vials are on back order and the company estimates a release date of mid- to late-March 2019.

The 0.25% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a



release date of mid- to late-March 2019. The 0.5% Sensorcaine-MPF with epinephrine 30 mL sterile

packs are on back order and the company cannot estimate a release date.

Pfizer has 0.25% bupivacaine with epinephrine 10 mL and 30 mL preservative-free vials on back

order and the company estimates a release date of September 2019. The 0.25% bupivacaine with

epinephrine 50 mL vials are on back order and the company estimates a release date of September

2019. The 0.5% bupivacaine with epinephrine 10 mL preservative-free vials are on back order and

the company estimates a release date of September 2019. The 0.5% bupivacaine with epinephrine

30 mL preservative-free vials are on back order and the company estimates a release date of April

2019.The 0.5% bupivacaine with epinephrine 50 mL vials are on back order and the company

estimates a release date of September 2019.

Pfizer has 0.25% Marcaine with epinephrine 30 mL preservative-free vials on back order and the

company estimates a release date of September 2019. The 0.25% Marcaine with epinephrine 10 mL

preservative-free vials are on back order and the company estimates a release date of March 2020.

The 0.25% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a

release date of September 2019. The 0.5% Marcaine with epinephrine 10 mL and 30 mL

preservative-free vials are on back order and the company estimates a release date of March 2020.

The 0.5% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a

release date of September 2019.


Butorphanol Tartrate Injection

March 11, 2019


Pfizer has butorphanol injection on shortage due to manufacturing delays.


Pfizer has butorphanol 1 mg/mL 1 mL vials on back order and the company estimates a release date

of April 2019.


Calcium Chloride Injection

March 11, 2019


American Regent has calcium chloride injection available.

Amphastar has calcium chloride injection available.

Pfizer has calcium chloride on shortage due to manufacturing delays.

Mylan Institutional has withdrawn calcium chloride syringes from the market. The company recalled

the syringes in April 2015 due to incompatibility of the syringes and some needless adaptors.


Pfizer has calcium chloride 100 mg/mL 10 mL Ansyr syringes available in limited supply. The 100

mg/mL 10 mL LifeShield syringes are on back order and the company estimates a release date of

March 2019.




Calcium Gluconate Injection

March 11, 2019


American Regent is not currently marketing calcium gluconate.

Fresenius Kabi has calcium gluconate available.

WG Critical Care launched calcium gluconate premixed bags in January 2019.


Fresenius Kabi has calcium gluconate 100 mg/mL 100 mL vials on back order and the company

estimates a release date of mid- to late-March 2019.


Cefazolin Injection

March 11, 2019


Apotex has discontinued all presentations except cefazolin 1 gram vials.

Baxter did not provide a reason for the shortage.

BBraun has cefazolin on shortage due to manufacturing delays.

Fresenius Kabi has cefazolin on shortage due to increased demand. They are not manufacturing the

20 gram vials at this time to focus on the other sizes.

Pfizer states the reason for the shortage is manufacturing delay.

Sagent states the reason for the shortage is manufacturing delays and increased demand.

Samson Medical Technologies has cefazolin injection available.

Sandoz has cefazolin injection available.


WG Critical Care did not provide a reason for the shortage.


Baxter has cefazolin 2 gram/100 mL premixed bags on allocation.

BBraun has 1 gram/50 mL and 2 gram/50 mL premixed bags on allocation.

Fresenius Kabi has cefazolin 500 mg vials on back order and the company estimates a release date of

mid- to late-March 2019. The 1 gram vials are on back order and the company estimates a release

date of late-April 2019. The 10 gram vials are on back order and the company estimates a release

date of 2nd quarter 2019.

Pfizer has 1 gram and 10 gram vials on back order and the company estimates a release date of

September 2019. The 1 gram ADD-Vantage vials are on back order and the company estimates a

release date of June 2019.

Sagent has cefazolin 500 mg and 10 gram vials on back order and the company cannot estimate a

release date. The 1 gram vials are on back order and the company estimates a release date of April

2019.

Hikma has cefazolin 500 mg vials on back order and the company estimates a release date of April to

May 2019. The 1 gram and 10 gram vials are on allocation.



WG Critical Care has cefazolin 500 mg vials on back order and the company cannot estimate a

release date. The 1 gram vials are on intermittent back order with regular releases. The 10 gram vials

are on back order and the company estimates a release date of late-April 2019.


Diltiazem Hydrochloride Injection

March 11, 2019


Akorn states the reason for the shortage was increased demand due to market conditions. They are

not currently producing the 25 mL vials in 10 count.

Pfizer states the reasons for the shortage is manufacturing delays and increases in demand.

Hilkma has diltiazem injection on shortage due to manufacturing delays caused by increased demand

due to current market conditions.


Akorn has diltiazem 5 mg/mL 5 mL, 10 mL, and 25 mL vials on allocation.

Hikma has diltiazem 5 mg/mL 25 mL vials on allocation.

Pfizer has 100 mg ADD-Vantage vials on back order and the company estimates a release date of

June 2019. The 5 mg/mL 5 mL and 10 mL vials are also on back order and the company estimates a

release date of March 2020 for the 5 mL vials and August 2019 for the 10 mL vials.


Etomidate Injection

March 11, 2019


American Regent is not currently marketing etomidate.

AuroMedics has etomidate available.

Hikma has etomidate available.

Mylan did not provide a reason for the current shortage.

Par Sterile Products discontinued etomidate in early 2015.

Pfizer has Amidate on shortage due to manufacturing delays. Pfizer discontinued etomidate ampules

in October 2016.

Sagent is no longer marketing etomidate.

Zydus has etomidate available.


AuroMedics has etomidate 2 mg/mL 10 mL and 20 mL vials on intermittent back order and the


Pfizer has Amidate 2 mg/mL 20 mL LifeShield syringes on back order and the company estimates a





Famotidine Injection

March 11, 2019


Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.[1]


Pfizer launched famotidine injections in March 2012.[3]

Mylan Institutional acquired famotidine injections from Pfizer on December 6, 2013.[4]

Fresenius Kabi did not provide a reason for the shortage.[5]

Baxter did not provide a reason for the shortage.[6]


Baxter has famotidine 20 mg/50 mL premixed bags on back order and the company cannot estimate

a release date.[6]


Leucovorin Calcium Injection

March 11, 2019


Fresenius Kabi had leucovorin on shortage due to manufacturing delays and increased demand.

Hikma did not provide a reason for the current shortage.

Sagent has leucovorin on shortage due to manufacturing delays.

Teva has leucovorin available.


Hikma has leucovorin 200 mg and 350 mg vials on back order and the company estimates a release

date of April to May 2019 for the 350 mg vials and cannot estimate a release date for the 200 mg

vials.

Sagent has leucovorin 200 mg and 500 mg vials on allocation.


Mannitol Injection

March 11, 2019


American Regent is not currently marketing mannitol.

Baxter did not provide a reason for the mannitol shortage.

BBraun has mannitol 500 mL premixed bags available. The 250 mL premixed bags were discontinued.

Fresenius Kabi had mannitol on shortage due to increased demand.

Pfizer has mannitol on shortage due to manufacturing delays.


Fresenius Kabi has mannitol 250 mg/mL 50 mL vials on back order and the company estimates a


Pfizer has mannitol 250 mg/mL 50 mL vials available in limited supply.




Morphine Sulfate Immediate-Release Tablets

March 11, 2019




Hikma has all morphine immediate-release tablets on allocation.


Rocuronium Injection

March 11, 2019


Athenex has rocuronium available.


Fresenius Kabi has rocuronium available.


Pfizer has rocuronium on shortage due to manufacturing delays.

Sagent has rocuronium available.

Sandoz has rocuronium available.

X-Gen has rocuronium available.


AuroMedics has rocuronium 10 mg/mL 5 mL and 10 mL vials on intermittent back order and the


Fresenius Kabi has rocuronium 10 mg/mL 5 mL vials on back order and the company estimates a


Mylan Institutional has rocuronium 10 mg/mL 10 mL vials on back order and the company cannot


Pfizer has rocuronium 10 mg/mL 5 mL vials available in limited supply. The 10 mL vials are on back

order and the company estimates a release date of March 2019.


BCG Live Intravesical

March 12, 2019


Because of increased global demand, and as the only source of BCG Live (Intravesical) in the United

States and many other countries, Merck anticipates supply constraints for Tice BCG in 2019. To

minimize disruption to patient care and address the current imbalance between supply and

increased global demand, Tice BCG will be under allocation when demand exceeds production plans

and available inventory.


Merck has Tice BCG on allocation.




Busulfan Injection

March 12, 2019


American Regent did not provide a reason for the shortage.

Amneal did not provide a reason for the shortage.

Sagent has busulfan on shortage due to increased demand.


American Regent has busulfan 6 mg/mL 10 mL vials available in limited supply.

Amneal has busulfan 6 mg/mL 10 mL vials on back order and the company cannot estimate a release

date.

Mylan has busulfan 6 mg/mL 10 mL vials on back order and the company estimates a release date of

April 2019. Short dated (February 2020) vials are available.


Carbidopa and Levodopa Extended-Release Tablets

March 12, 2019


Accord has discontinued carbidopa and levodopa 25 mg/100 mg extended-release tablets. The 50

mg/200 mg tablets are on shortage due to problems obtaining active ingredient.

Sun Pharma had carbidopa and levodopa extended-release tablets on shortage due to increased

demand.

Merck had Sinemet CR on shortage due to increased demand.

Mylan did not provide a reason for the carbidopa and levodopa extended-release tablet shortage.


Accord has carbidopa and levodopa 50 mg/200 mg extended-release tablets on allocation.

Mylan has carbidopa and levodopa 25 mg/100 mg extended-release tablets in 100 count unit-dose

packs on back order and the company cannot estimate a release date. The carbidopa and levodopa

50 mg/200 mg extended-release tablets in 100 count unit-dose packs are on back order and the

company estimates a release date of mid-May 2018. The 50 mg/200 mg extended release tablets in

100 count bottles are on back order and the company estimates a release date of early-April 2019.

The 25 mg/100 mg extended release tablets in 100 count bottles are on back order and the company

estimates a release date of late-May 2019.

Merck has Sinemet CR 25 mg/100 mg extended release tablets in 100 count bottles on back order



Cyclosporine Injection

March 12, 2019


Novartis has Sandimmune available.

Perrigo did not provide a reason for the shortage.




Perrigo has cyclosporine 50 mg/mL ampules on back order and the company estimates a release

date of mid-March 2019.


Diltiazem Extended-Release Capsules (Twice-Daily Dosing)

March 12, 2019




Mylan has diltiazem extended-release 60 mg, 90 mg, and 120 mg capsules in 100 count bottles on

back order and the company estimates a release date of mid-March 2019.

Mylan Institutional has diltiazem extended-release 60 mg, 90 mg, and 120 mg capsules in 100 count

unit-dose packs on back order and the company estimates a release date of late-April to early-May

2019 for the 60 mg capsules and mid- to late-March 2019 for the 90 mg and 120 mg tablets.


Fluorouracil Injection

March 12, 2019




Sagent has fluorouracil injection on shortage due to increased demand.

Teva had fluorouracil injection on allocation due to increased demand.


Fresenius Kabi has fluorouracil 50 mg/mL 100 mL vials on back order and the company estimates a

release date of mid-March 2019.

Sagent has fluorouracil 50 mg/mL 100 mL vials on back order and the company estimates a release

date of March 2019.

Teva has fluorouracil 50 mg/mL 100 mL vials on allocation.


Methotrexate Injection

March 12, 2019


Accord has methotrexate injection on back order due to increased demand.[1]

Fresenius Kabi has methotrexate injection available.[2]

Mylan Institutional has methotrexate injection available. Mylan Institutional discontinued the 40

mg/mL 2 mL, 4 mL, and 8 mL vials in late-2017.[3]

Pfizer did not provide a reason for the shortage.[4]

Teva has methotrexate injection on shortage due to increased demand.[5]

Hikma has methotrexate injection available.[6]




Accord has methotrexate 25 mg/mL 2 mL and 40 mL preservative-free vials on back order and the

company estimates a release date of mid- to late-March 2019.

Mylan Institutional has methotrexate 25 mg/mL 40 mL preservative-free vials on back order and the

company estimates a release date of mid-March 2019.

Teva has methotrexate 25 mg/mL 40 mL preservative-free vials on allocation. Check wholesaler for

inventory.


Mupirocin Calcium 2% Cream

March 12, 2019


GlaxoSmithKline is looking for an alternative supply source.

Glenmark did not provide a reason for the shortage.

Prasco discontinued mupirocin calcium 2% cream in February 2016.


GlaxoSmithKline has Bactroban 2% cream in 15 gram and 30 gram sizes on long-term back order and


Glenmark has mupirocin 2% cream in 15 gram tubes on back order and the company cannot



Mupirocin Calcium 2% Nasal Ointment

March 12, 2019


GlaxoSmithKline states the shortage is due to manufacturing issues. GlaxoSmithKline is looking for an

alternative supply source.[1]


GlaxoSmithKline has Bactroban Nasal 2% Ointment in 1 gram tubes on long-term back order and the

company cannot estimate a release date.[1]


Nelarabine Injection

March 12, 2019


Novartis did not provide a reason for the shortage.


Novartis has Arranon 5 mg/mL 50 mL vials on a limited allocation.




Prednisolone Acetate 1% Ophthalmic Suspension

March 12, 2019


Allergan did not provide a reason for the shortage.

Greenstone did not provide a reason for the shortage.

Novartis discontinued Omnipred 1% in 2018.

Sandoz has prednisolone acetate on shortage due to increased demand.


Allergan Pred Forte in 5 mL and 10 mL on back order and the company estimates a release date of

late-March to early-April 2019.

Greenstone has all prednisolone acetate 1% presentations on back order and the company estimates

a release date of mid- to late-March 2019.

Sandoz has prednisolone acetate 1% 10 mL and 15 mL bottles on back order and the company

estimates a release date of mid-March 2019.


RimabotulintoxinB Intramuscular Injection

March 12, 2019


Solstice Neurosciences, Inc. did not provide a reason for the shortage.


Solstice Neurosciences, Inc. has Myobloc 5000 unit/mL 0.5 mL vials on back order and the company



Argatroban Injection

March 13, 2019


AuroMedics has argatroban available.

Chiesi has argatroban available.




Par did not provide a reason for the shortage.

Pfizer had argatroban on shortage due to manufacturing delay.


Teva has argatroban temporarily unavailable.


Fresenius Kabi has argatroban 100 mg/mL 2.5 mL vials on back order and the company estimates a

release date in mid-April 2019.

Hikma has argatroban 1 mg/mL 50 mL vials on allocation.



Mylan has argatroban 100 mg/mL 2.5 mL vials on back order and the company estimates a release

date in mid-May 2019.

Par has argatroban 100 mg/mL 2.5 mL vials on back order and the company cannot estimate a

release date.

Novartis has argatroban 100 mg/mL 2.5 mL vials available with short expiration dating (November

2019).

Sandoz has argatroban 1 mg/mL 50 mL vials on back order and the company cannot estimate a

release date.


Buprenorphine Hydrochloride Injection

March 13, 2019


Pfizer has buprenorphine injection on shortage due to manufacturing delays.

Par had buprenorphine injection on shortage due to increased demand.


Pfizer has buprenorphine 0.3 mg/mL 1 mL Carpuject syringes on back order and the company

estimates a release date of June 2019.


Dorzolamide 2% and Timolol 0.5% Ophthalmic Solution

March 13, 2019


Akorn has dorzolamide and timolol ophthalmic solution on shortage due to manufacturing delays.


Teva discontinued dorzolamide and timolol ophthalmic solution in April 2018.

Bausch Health has dorzolamide and timolol ophthalmic solution on shortage due to manufacturing

delays.


Akorn has Cosopt 2%/0.5% ophthalmic solution in 10 mL bottles on back order and the company

cannot estimate a release date. Dorzolamide 2% and timolol 0.5% ophthalmic solution in 10 mL

bottles are available on allocation.

Bausch Health has dorzolamide 2% and timolol 0.5% ophthalmic solution in 10 mL bottles on back

order and the company estimates a release date of mid-March 2019.

Sandoz has dorzolamide 2% and timolol 0.5% ophthalmic solution in 10 mL bottles on back order and

the company estimates a release date of late-March 2019.




Dorzolamide Ophthalmic Solution

March 13, 2019


Akorn has dorzolamide ophthalmic solution on shortage due to manufacturing delays.

Merck did not provide a reason for the shortage.


Teva discontinued dorzolamide ophthalmic solution in April 2018.

Bausch Health had dorzolamide ophthalmic solution on shortage due to manufacturing delays.


Akorn has dorzolamide 2% ophthalmic solution in 10 mL bottles on allocation.

Sandoz has dorzolamide 2% ophthalmic solution in 10 mL bottles on back order and the company

estimates a release date of early-April 2019.


Guanfacine Hydrochloride Tablets

March 13, 2019






Mylan has guanfacine 1 mg and 2 mg tablets in 100 count bottles on back order and the company

estimates a release date of mid- to late-August 2019.

Teva has guanfacine 1 mg and 2 mg tablets in 100 count bottles on back order and the company

estimates a release date of mid-April 2019 and late-May 2019.


Polyvinyl Alcohol (Artificial Tears) Ophthalmic Solution

March 13, 2019



Altaire is not currently marketing polyvinyl alcohol 1.4% ophthalmic solution.

Major has polyvinyl alcohol 1.4% ophthalmic solution available.

Ocusoft has polyvinyl alcohol 1.4% ophthalmic solution available.

Rugby has polyvinyl alcohol 1.4% ophthalmic solution available.


Akorn has Artificial Tears Solution ophthalmic drops on back order and the company cannot estimate

a release date.

Major has Liquitears ophthalmic drops on back order and the company cannot estimate a release

date.




Proparacaine Hydrochloride Ophthalmic Solution

March 13, 2019


Akorn, Bausch Health, and Sandoz did not provide a reason for the shortage.


Akorn has proparacaine 0.5% ophthalmic drops on allocation.

Bausch Health has proparacaine 0.5% ophthalmic drops on back order and the company estimates a


Sandoz has proparacaine 0.5% ophthalmic drops on back order and the company estimates a release

date in late-March 2019.


Rosuvastatin Calcium Tablets

March 13, 2019


Accord, Biocon, Glenmark, Mylan, Sandoz, and Rising did not provide a reason for the shortage.

Apotex has discontinued production of all rosuvastatin presentations.

Mylan has discontinued all rosuvastatin presentations.

Sun Pharma will be discontinuing production of all rosuvastatin presentations.


Accord has rosuvastatin 5 mg tablets in 90 count, 5 mg tablets in 1,000 count, 20 mg tablets in 1,000

count, and 40 mg tablets in 30 count on back order and the company estimates a release date of

mid- to late-March 2019. The 10 mg tablets in 1,000 count bottles are on back order and the

company estimates a release date of late-March 2019. The 40 mg tablets in 1,000 count bottles are

on back order and the company estimates release dates of early- to mid-April 2019.

Biocon has rosuvastatin 40 mg tablets in limited supply.

Rising has all rosuvastatin presentations on back order and the company estimates release dates of

late-March 2019.

Sandoz has rosuvastatin 10 mg tablets in 90-count bottles on back order and the company estimates

a release date of early-April 2019.

Sun Pharma will be discontinuing production of rosuvastatin 5 mg, 10 mg, 20 mg, and 40 mg tablets

in 90 count bottles.


Amphetamine Mixed Salts, Immediate-Release Tablets

March 14, 2019


Aurobindo did not provide a reason for the shortage.

Mallinckrodt has amphetamine mixed salts available.


Sun Pharma did not provide a reason for the shortage.

Teva has Adderall and amphetamine mixed salts available.



Zydus has amphetamine mixed salts available.


Aurobindo has amphetamine mixed salts, immediate-release 10 mg tablets on back order and the


Mylan has all amphetamine mixed salts, immediate-release tablets on back order and the company

estimates a release date of late-June 2019.

Sun Pharma has amphetamine mixed salts, immediate-release 10 mg tablets available in limited

supply. The 15 mg tablets are available in limited supply as short-dated product (June 2019). All

other strengths are on back order and the company cannot estimate a release date.

Zydus has all amphetamine mixed salts, immediate-release tablets available on allocation.


Deferoxamine Injection

March 14, 2019


Fresenius Kabi had deferoxamine on shortage due to increased demand.

Pfizer has deferoxamine on shortage due to manufacturing delays.

Novartis has Desferal available.

Alvogen launched deferoxamine injection in mid-2018.

Apo-Pharma launched deferoxamine injection in mid-2018.


Pfizer has deferoxamine 500 mg vials on back order and the company estimates a release date of

June 2019.


Dicyclomine Oral Presentations

March 14, 2019



Lannett did not provide a reason for the shortage.


Par Pharmaceuticals has dicyclomine oral solution available.



Hikma has 10 mg capsules in 100 and 1,000 count bottles and 20 mg tablets in 100 and 1,000 count

bottles on available on allocation.

Lannett has 20 mg tablets in 1,000 count bottles on back order and the company estimates a release

date of March 2019.

Mylan has 10 mg capsules in 100 and 500 count bottles on back order and the company estimates a

release date of early- to mid-April 2019. The 20 mg tables in 100 and 500 count bottles are on back

order and the company estimates a release date of mid-April 2019.



Mylan Institutional has 10 mg capsules and 20 mg tablets on back order and the company estimates

a release date of mid-May 2019.

Teva has 20 mg tablets in 1,000 count bottles on back order and the company estimates a release

date of late-March 2019.


Epinephrine Auto-Injectors

March 14, 2019


Amneal has discontinued Adrenaclick. Amneal acquired Impax in 2018.

Mylan had EpiPen on shortage due to supply constraints.

Sandoz launched Symjepi in January 2019 and product is available.

Teva has FDA approval for generic epinephrine.


Amneal has epinephrine 0.15 mg/0.15 mL and 0.3 mg/0.3 mL auto-injectors on allocation.

Teva has epinephrine 0.3 mg/0.3 mL auto injectors on back order and the company cannot estimate

a release date.


Melphalan Tablets

March 14, 2019


Apo-Pharma did not provide a reason for the shortage.


Apo-Pharma has melphalan 2 mg tablets on long-term back order and the company cannot estimate

a release date.


Meperidine Hydrochloride Injection

March 14, 2019


Pfizer has Demerol injection on shortage due to manufacturing delays.

ICU Medical discontinued meperidine 30 mL PCA vials.


Hikma has meperidine 50 mg/mL 1 mL vials on back order and the company estimates a release date

of April to May 2019.

Pfizer has Demerol 100 mg/mL 20 mL vials and on back order and the company estimates a release

date of March 2020. The 25 mg/mL 1 mL Carpuject syringes and 50 mg/mL 1 mL Carpuject syringes

are on back order and the company estimates a release date of December 2019. The 75 mg/mL 1 mL

Carpuject syringes and 100 mg/mL 1 mL Carpuject syringes are on back order and the company

estimates a release date of December 2019. The 50 mg/mL 30 mL vials are on back order and the

company estimates a release date of June 2019.




Remifentanil Injection

March 14, 2019



Fresnius Kabi launched generic remifentanil in January 2018.


Mylan Institutional has Ultiva 1 mg vials on back order and the company cannot estimate a release

date.

Fresenius Kabi has remifentanil 2 mg and 5 mg vials on back order and the company cannot estimate

a release date. The 1 mg vials are on back order and the company estimates a release date of early-

April 2019.


Sodium Polystyrene Sulfonate Oral or Rectal Suspension

March 14, 2019


CMP Pharma reports that increased demand has led to a shortage of raw material required to

manufacture the products.

Perrigo has temporarily discontinued their Kionex suspension and sodium polystyrene sulfonate

(sorbitol-free) suspension. They cannot estimate when these products will be manufactured again.

Hikma is not currently marketing sodium polystyrene sulfonate suspension.


CMP Pharma has SPS suspension on intermittent back order and the company is releasing supplies as

they become available.


Testosterone Enanthate Intramuscular Injection

March 14, 2019





Teva has testosterone enanthate 200 mg/mL 5 mL vials temporarily unavailable with no estimated

release date.


Buspirone Tablets

March 15, 2019








Accord has all buspirone presentations on allocation.

Mylan Institutional has buspirone 5 mg, 10 mg, 15 mg, and 30 mg tablets in 100 count unit-dose

packs on back order and the company cannot estimate a release date.

Mylan has all buspirone presentations in bottles on long-term back order and the company cannot


Teva has buspirone 30 mg tablets in 60 and 180 count available in limited supply.

Zydus has all buspirone presentations on allocation.


Cefuroxime Sodium Injection

March 15, 2019


Sagent has cefuroxime injection on shortage due to manufacturing delays.

Teligent discontinued all Zinacef presentations in February 2018.

Hikma did not provide a reason for the cefuroxime injection shortage. They are not currently

marketing the 7.5 gram vials.


Sagent has cefuroxime 750 mg and 1.5 gram vials on back order and the company cannot estimate a

release date.

Hikma has cefuroxime 750 mg and 1.5 gram vials on back order and the company estimates a release

date of late-March to early-April 2019 for the 750 mg vials and late-March 2019 for the 1.5 gram

vials.


Doxorubicin Injection

March 15, 2019


Hikma did not provide a reason for the shortage of Adriamycin.[1]

Teva had doxorubicin solution for injection on shortage due to increased demand. They discontinued

doxorubicin presentations with NDCs starting in 00703 in early-January 2019.[2-3]

Fresenius Kabi did not provide a reason for the shortage.[4]

Caraco has discontinued doxorubicin solution for injection 25 mL and 100 mL vials.[5]

Pfizer has doxorubicin on shortage due to manufacturing delays.[6]

Sagent discontinued doxorubicin solution for injection in late-2017.[7]

Mylan Institutional did not provide a reason for the shortage of doxorubicin lyophilized powder for

injection.[8]

Athenex has doxorubicin available.[9]

FDA was allowing temporary importation of doxorubicin lyophilized powder for injection 50 mg vials.

These vials were manufactured for Hospira UK Limited. The labeling as well as bar coding for the



imported product is different from the US version. FDA has the Dear Healthcare Professional Letter

linked on their website. The letter includes a link to both the US and United Kingdom package inserts

to help explain the differences in labeling and packaging. The link to the letter is

http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM507498.pdf. Ordering can be

done directly with Hospira Customer Care at 877-946-7747.[10-11]


Athenex has doxorubicin 2 mg/mL 25 mL vials on back order and the company cannot estimate a

release date. The 100 mL vials have short expiration dating of April 2019.9

Fresenius Kabi has doxorubicin 25 mL vials available with short-expiration dating (< 6 months).[4]

Hikma has Adriamycin 25 mL vials are on back order and the company estimates a release date of

late-March 2019. There are short-dated 2 mg/mL 10 mL vials available with an expiration date of

June 2019. The 50 mg vials are on back order and the company estimates a release date of late-

March 2019. [1]

Mylan Institutional has doxorubicin lyophilized powder 10 mg vials on back order and the company

cannot estimate a release date. The 50 mg vials are on back order and the company estimates a

release date of early-April 2019.[8]

Pfizer has doxorubicin 2 mg/mL 5 mL vials available in limited supply.[6]

Sagent has doxorubicin 2 mg/mL 5 mL, 10 mL, and 25 mL vials on back order and the company

estimates a relaunch date of March 2019.7

Teva has doxorubicin 2 mg/mL 10 mL vials on intermittent back order and the company is allocating

product upon release.[2]


Labetalol Injection

March 15, 2019


Akorn did not provide a reason for the shortage.[1]

Alvogen did not provide a reason for the shortage.[2]

Pfizer has labetalol injection on shortage due to manufacturing delays.[3]

Hikma has labetalol injection on shortage due to increase demand.[4]


Akorn has labetalol 5 mg/mL 20 mL vials on allocation. The 40 mL vials are on back order and the

company cannot estimate a release date.[1]

Alvogen has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company cannot

estimate a release date.[2]

Hikma has labetalol 5 mg/mL 20 mL vials on back order and the company estimates a release date of

mid-March 2019. The 40 mL vials are on allocation.[4]

Pfizer has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company estimates a

release date of December 2019 for the 20 mL vials and July 2019 for the 40 mL vials. The 5 mg/mL 4

mL Carpuject syringes are on back order and the company estimates a release date of March

2019.[3]




Temazepam Capsules

March 15, 2019


Ascend did not provide a reason for the shortage.

Major has temazepam on shortage due to manufacturing delays.

Mylan has temazepam on shortage due to manufacturing delays.

Sun Pharma has temazepam available.

Teva has temazepam available.

Mallinckrodt has Restoril capsules available.


Ascend has temazepam 15 mg capsules in 100 count on allocation. The 7.5 mg capsules in 100 count

and 30 mg capsules in 500 count are on back order and the company cannot estimate a release date.

Major has temazepam 7.5 mg capsules in 100 count bottles on back order and the company cannot


Mylan has temazepam 15 mg capsules in 100 and 500 count, 22.5 mg capsules in 30 count, and 30

mg capsules in 100 and 500 count on back order and the company estimates a release date of August

2019.

Mylan Institutional has temazepam 30 mg capsules in 100 count unit-dose packs on back order and

the company estimates a release date of early-September 2019.


23.4% Sodium Chloride Injection

March 18, 2019


Fresenius Kabi has 23.4% sodium chloride injection on shortage due to increased demand.

Pfizer has 23.4% sodium chloride injection on shortage due to increased demand.


Fresenius Kabi has 23.4% sodium chloride 200 mL vials on back order and the company estimates a

release date of mid-April 2019. Check wholesalers for inventory.

Pfizer has 23.4% sodium chloride 200 mL vials on back order and the company estimates a release

date of September 2019.


Acetazolamide Injection

March 18, 2019




X-Gen has acetazolamide on shortage due to manufacturing delays.


Hikma has acetazolamide 500 mg vials on allocation.



Mylan Institutional has acetazolamide 500 mg vials on back order and the company cannot estimate

a release date.

X-Gen has acetazolamide 500 mg vials on back order and the company estimates a release date of

late-March 2019.


Acetylcysteine Oral and Inhalation Solution

March 18, 2019


American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing

delays. They are not currently marketing the 10 mL and 30 mL vial presentations.

Fresenius Kabi has acetylcysteine oral and inhalation solution available.

Pfizer had acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.

Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014.

Arbor has Cetylev effervescent tablets available. These are for oral use only.


American Regent has acetylcysteine solution 100 mg/mL 4 mL vials available in limited supply.


Bacteriostatic 0.9% Sodium Chloride Vials

March 18, 2019



Pfizer has bacteriostatic sodium chloride vials on shortage due to manufacturing delays.


Pfizer has bacteriostatic 0.9% sodium chloride 30 mL vials on back order and the company estimates

a release date of May 2019. The 10 mL and 20 mL vials are available in limited supply.


Bupivacaine Injection

March 18, 2019


AuroMedics has not provided a reason for the shortage.

Fresenius Kabi had Sensorcaine on shortage due to increased demand for the product.

Pfizer has bupivacaine on shortage due to manufacturing delays. Pfizer discontinued 0.5%

bupivacaine 30 mL glass ampules in December 2017.


AuroMedics has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on intermittent back

order and the company is releasing product as it becomes available. The 0.5% bupivacaine 10 mL and

30 mL preservative-free vials are on intermittent back order and the company is releasing product as

it becomes available. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on

intermittent back order and the company is releasing product as it becomes available.



Fresenius Kabi has 0.25% Sensorcaine 10 mL preservative-free vials on back order and the company

estimates a release date of late-March 2019. The 0.25% 30 mL preservative-free vials are on back

order and the company estimates a release date of mid- to late-March 2019. The 0.25% 50 mL vials

are on back order and the company estimates a release date of mid- to late-March 2019. The 0.5%

Sensorcaine 10 mL preservative-free vials are on back order and the company estimates release

dates of mid- to late-March 2019. The 0.5% Sensorcaine 30 mL preservative-free vials are on back

order and the company estimates release dates of late-March 2019. The 0.5% Sensorcaine 50 mL

vials are on back order and the company estimates a release date of early-April 2019. The 0.25% and

0.5% Sensorcaine 30 mL preservative-free vials in sterile packs are on back order and the company

cannot estimate release dates.

Pfizer has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on back order and the

company estimates a release date of March 2019. The 0.25% bupivacaine 50 mL vials are on back

order and the company estimates release dates of March 2019. The 0.5% bupivacaine 10 mL and 30

mL preservative-free vials are on back order and the company estimates a release date of March

2019 for the 10 mL vials and May 2019 for the 30 mL vials. The 0.5% bupivacaine 50 mL vials are on

back order and the company estimates a release date of March 2019. The 0.75% bupivacaine 10 mL

and 30 mL preservative-free vials are on back order and the company estimates a release date of

March 2019 for the 10 mL vials and June 2019 for the 30 mL vials.

Pfizer has 0.25% Marcaine 10 mL and 30 mL preservative-free vials on back order and the company

estimates a release date of March 2020 for the 10 mL vials and June 2019 for the 30 mL vials. The

0.25% 50 mL vials are on back order and the company estimates a release date of March 2020. The

0.5% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company

estimates a release date of March 2020. The 0.5% 50 mL vials are on back order and the company

estimates a release date of June 2019. The 0.75% Marcaine 10 mL and 30 mL preservative-free vials

are on back order and the company estimates a release date of March 2020.


Dexamethasone Sodium Phosphate Injection

March 18, 2019


American Regent is not marketing dexamethasone sodium phosphate injection at this time.

AuroMedics has dexamethasone sodium phosphate on intermittent back order.

Fresenius Kabi has dexamethasone sodium phosphate presentations available.

Mylan Institutional has dexamethasone sodium phosphate available.



AuroMedics has dexamethasone sodium phosphate 4 mg/mL 1 mL, 5mL, and 30 mL vials on


Fresenius Kabi has dexamethasone sodium phosphate 4 mg/mL 1 mL prefilled syringes on back order

and the company estimates a release date of 2nd quarter 2019. The 10 mg/mL 1 mL preservative-

free vials are on back order and the company estimates a release date of mid-April 2019. The 4

mg/mL 1 mL and 5 mL vials are on back order and the company estimates a release date of mid- to



late-March 2019. The 10 mg/mL 10 mL vials are on back order and the company estimates a release

date of late-April to early-May 2019.

Hikma has dexamethasone sodium phosphate 4 mg/mL 1 mL and 5 mL vials on back order and the

company cannot estimate a release date. The 10 mg/mL 1 mL vials are on allocation.

Mylan Institutional has dexamethasone 40 mg/mL 5 mL and 30 mL vial on back order and the

company estimates a release date of mid- to late-June 2019.


Diphenhydramine Injection

March 18, 2019


Fresenius Kabi has diphenhydramine injection on shortage due to increased demand.[1]


Mylan did not provide a reason for the shortage.[3]

Pfizer has dipehnhydramine injection on shortage due to manufacturing delays.[4]


Fresenius Kabi has diphenhydramine 50 mg/mL 1 mL vials on back order and the company estimates

a release date of mid- to late-March 2019. Check wholesalers for inventory.[1]

Mylan Institutional has diphenhydramine 50 mg/mL 10 mL vials on back order and the company

estimates a release date of mid-April 2019.[3]

Pfizer has diphenhydramine 50 mg/mL 1 mL vials on back order and the company estimates a release

date of March 2020.[4]


Hydromorphone Hydrochloride Injection

March 18, 2019


Akorn has hydromorphone injection on shortage due to increased demand.[1]

Fresenius Kabi has Dilaudid syringes on shortage due to increased demand. They are focusing their

product on the 0.5 mg strength. They launched hydromorphone vials in late-June 2018.[2]

Pfizer did not provide a reason for the shortage.[3]

Purdue discontinued Dilaudid and Dilaudid HP in May 2017 for marketing reasons.[4]

Teva did not provide a reason for the shortage.[5]



Fresenius Kabi has Dilaudid 2 mg/mL 1 mL syringes on back order and the company cannot estimate

a release date. The hydromorphone 1 mg/mL 1 mL vials and 4 mg/mL 1 mL vials are on back order

and the company estimates a release date of mid- to late-March 2019. The hydromorphone 10

mg/mL 1 mL vials are on back order and the company cannot estimate a release date. Check

wholesalers for inventory.[2]

Pfizer has 1 mg/mL 1 mL Carpuject syringes available in limited supply. The 10 mg/mL 50 mL vials are

on back order and the company estimates a release date of June 2019. The 10 mg/mL 5 mL vials are



on back order and the company estimates a release date of April 2019. The 0.5 mg/0.5 mL 0.5 mL

iSecure syringes and 2 mg/mL 1 mL Carpuject syringes are on back order and the company estimates

a release date of June 2019. The 1 mg/mL 1 mL ampules, 2 mg/mL 1 mL ampules, and 4 mg/mL 1 mL

ampules are on back order and the company estimates a release date of June 2019. The 1 mg/mL 1

mL iSecure syringes, 2 mg/mL 1 mL iSecure syringes, and 4 mg/mL 1 mL Carpuject syringes are on

back order and the company estimates a release date of December 2019. The 2 mg/mL 1 mL vials are

available in limited supply.[3]

Teva has 10 mg/mL 1 mL, 5 mL, and 50 mL vials on intermittent back order and the company is

allocating upon release.[5]


Lidocaine Injection

March 18, 2019


Amphastar had lidocaine 2% emergency syringes on shortage due to increase demand for the

product.

AuroMedics introduced lidocaine injection in February 2014.

Fresenius Kabi had generic lidocaine presentations on shortage due to a supply interruption of raw

ingredients.

Pfizer has lidocaine presentations on shortage due to manufacturing delays.


Amphastar has 2% lidocaine 5 mL syringes on intermittent back order and the company is releasing


AuroMedics has 1% lidocaine 5 mL ampules and 5 mL vials on intermittent back order and the

company is releasing product as it becomes available. AuroMedics has 2% lidocaine 5 mL vials on


Fresenius Kabi has 1% Xylocaine 20 mL vials on back order and the company estimates a release date

of mid- to late-March 2019. The 1% Xylocaine-MPF 2 mL and 30 mL vials are on back order and the

company estimates a release date of early- to mid-April 2019 for the 2 mL vials and early-April 2019

for the 30 mL vials. The 1% lidocaine 2 mL vials are on back order and the company cannot estimate

a release date. The 1% lidocaine 10 mL vials are on back order and the company estimates a release

date of early-April 2019. The 1% Xylocaine-MPF 30 mL vial sterile packs are on back order and the

company cannot estimate a release date. The 1.5% Xylocaine-MPF 10 mL ampules are on back order

and the company cannot estimate a release date.The 2% Xylocaine 20 mL vials are on back order and

the company estimates a release date of mid- to late-March 2019. Check wholesalers for inventory.

Hikma has 2% lidocaine 5 mL vials on allocation.

Pfizer has 1% lidocaine 5 mL preservative-free ampules on back order and the company estimates a

release date of March 2020. The 1% lidocaine 20 mL vials are on back order and the company

estimates a release date of March 2019. The 1% lidocaine 30 mL preservative-free vials are on back

order and the company estimates a release date of March 2019. The 1% lidocaine 50 mL vials are on

back order and the company estimates a release date of March 2019. The 1% lidocaine 5 mL

Lifeshield syringes are on back order and the company estimates a release date of August 2019. The

1.5% lidocaine 10 mL preservative-free ampules are on back order and the company cannot estimate



a release date. The 1.5% lidocaine 20 mL preservative-free ampules are on back order and the

company estimates a release date of mid-March 2019. The 2% lidocaine 10 mL ampules are on back

order and the company estimates a release date of June 2019. The 2% lidocaine 5 mL vials are on

back order and the company estimates a release date of December 2019. The 2% lidocaine 20 mL

vials are on back order and the company estimates a release date of June 2019. The 2% lidocaine 50

mL vials are available in limited supply. The 2% lidocaine 5 mL Lifeshield syringes are on back order

and the company estimates a release date of July 2019. The 2% lidocaine 5 mL Ansyr syringes are

available in limited supply. The 4% lidocaine 5 mL ampules are on back order and the company

estimates a release date of April 2019.


Lidocaine with Epinephrine Injection

March 18, 2019


Fresenius Kabi has Xylocaine with epinephrine presentations on shortage due to increased demand

for the product and manufacturing delays.

Pfizer has lidocaine with epinephrine presentations on shortage due to manufacturing delays.


Fresenius Kabi has 0.5% Xylocaine with epinephrine (1:200,000) 50 mL vials on back order and the

company estimates a release date of late-March 2019. The 1% Xylocaine with epinephrine

(1:200,000) 20 mL vials are on back order and the company estimates release dates of mid- to late-

March 2019. The 1% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the

company estimates release dates of mid- to late-March 2019. The 1% Xylocaine-MPF with

epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot

estimate a release date. The 1.5% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials are on

back order and the company estimates a release date of mid-March 2019. The 1.5% Xylocaine-MPF

with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot

estimate a release date. The 2% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back

order and the company estimates a release date of mid- to late-March 2019. The 2% Xylocaine-MPF

with epinephrine (1:200,000) 20 mL vials in sterile packs are on back order and the company cannot

estimate a release date. Check wholesalers for inventory.

Pfizer has 1% lidocaine with epinephrine (1:100,000) 20 mL vials on back order and the company

estimates a release date of March 2019. The 1% lidocaine with epinephrine (1:100,000) 30 mL vials

are on back order and the company estimates a release date of March 2019. The 1% lidocaine with

epinephrine (1:100,000) 50 mL vials are on back order and the company estimates a release date of

March 2019. The 1.5% lidocaine with epinephrine (1:200,000) 30 mL vials are on back order and the

company estimates a release date of June 2019. The 1.5% lidocaine with epinephrine (1:200,000) 5

mL glass ampules are available in limited supply. The 2% lidocaine with epinephrine (1:100,000) 20

mL vials are on back order and the company estimates a release date of March 2019. The 2%

lidocaine with epinephrine (1:100,000) 30 mL and 50 mL vials are on back order and the company

estimates a release date of April 2019 for the 30 mL vials and June 2019 for the 50 mL vials.




Mepivacaine Injection

March 18, 2019



Pfizer states the reason for the shortage is manufacturing delays.


Fresenius Kabi has 2% Polocaine 50 mL vials on back order and the company estimates a release date

of mid- to late-March 2019. The 2% Polocaine-MPF 20 mL vials are on back order and the company

estimates a release date of late-April 2019. Check wholesalers for inventory.

Pfizer has 2% Carbocaine 20 mL preservative-free vials, 2% Carbocaine 50 mL multiple-dose vials, 1%

Carbocaine 30 mL preservative-free vials, 1% Carbocaine 50 mL multiple-dose vials, and 1.5%

Carbocaine 30 mL preservative-free vials on back order and the company estimates a release date of

March 2020.


Mitoxantrone Hydrochloride Injection

March 18, 2019


Fresenius Kabi has mitoxantrone available.[1]

Pfizer had mitoxantrone injection on shortage due to manufacturing delays.[2]

Teva has mitoxantrone injection available except for the 10 mL vials which are temporarily

discontinued.[3]


Fresenius Kabi has short-dated mitoxantrone 2 mg/mL 15 mL vials available with an expiration date

of <7 months.[1]

Pfizer has mitoxantrone 2 mg/mL 12.5 mL vials on back order and the company estimates a release

date of July 2019. There are limited supplies of short-dated 12.5 mL vials with an expiration date of

August 2019.[2]

Teva has temporarily discontinued mitoxantrone 10 mL vials and the company cannot estimate a

release date.[3]


Morphine Injection

March 18, 2019


Fresenius Kabi procured morphine syringes from BD in 2016. They discontinued the 8 mg/mL and 10

mg/mL 1 mL syringes in early-2018.[1-2]

Astramorph injection has been unavailable since 2012. Fresenius Kabi changed manufacturing sites

and cannot estimate if Astramorph will return.[2]

Pfizer has a shortage of several prefilled syringe products, including morphine, starting in late-July

2017 due to issues at a manufacturing facility. To minimize the impact of the shortage, Pfizer is

prioritizing production of certain morphine Carpuject syringes.[3]





Fresenius Kabi has morphine 2 mg/mL 1 mL syringes on back order and the company estimates a

release date of early-April 2019. The morphine 4 mg/mL 1 mL syringes are on back order and the

company estimates a release date of 2nd quarter 2019. The morphine 5 mg/mL 1 mL syringes are on

back order and the company estimates a release date of 2nd quarter 2019. The 2 mg/mL 1 mL vials

are on back order and the company estimates a release date of mid-April 2019. The 4 mg/mL 1 mL

vials are on back order and the company estimates a release date of mid-April 2019. The 8 mg/mL 1

mL vials are on back order and the company cannot estimate a release date. Check wholesalers for

inventory.[2]

Pfizer has morphine 2 mg/mL 1 mL Carpuject syringes available in limited supply. The 0.5 mg/mL 10

mL preservative-free vials are on back order and the company estimates a release date of April 2019.

The 1 mg/mL 10 mL preservative-free vials are on back order and the company estimates a release

date of March 2019. The 2 mg/mL 1 mL iSecure syringes, 4 mg/mL 1 mL iSecure syringes, 8 mg/mL 1

mL iSecure syringes, and 10 mg/mL 1 mL iSecure syringes are on back order and the company

estimates a release date of December 2019. The 4 mg/mL 1 mL Carpuject syringes are on back order

and the company estimates a release date of April 2019. The 8 mg/mL 1 mL Carpuject syringes and

10 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of

June 2019. The 25 mg/mL 1 mL preservative-free vials are on back order and the company estimates

a release date of June 2019. The 50 mg/mL 20 mL vials are on back order and the company estimates

a release date of May 2019. The 50 mg/mL 50 mL vials are on back order and the company estimates

a release date of June 2019.[3]


Ondansetron Hydrochloride Injection

March 18, 2019


Apotex has ondansetron injection available.

Athenex had ondansetron injection on shortage due to increased demand.


Fresenius Kabi has ondansetron injection available.

Heritage had ondansetron on shortage due to increased demand. Heritage discontinued

ondansetron 2 mg/mL 2 mL vials in 10 count in late-2018.


Mylan Institutional has ondansetron injection available.

Pfizer has ondansetron injection on shortage due to manufacturing delays.

Sagent has ondansetron injection on shortage due to increased demand and manufacturing delays.

Novartis discontinued Zofran 20 mL vials in May 2018.


AuroMedics has ondansetron 2 mg/mL 2 mL vials and 20 mL vials on intermittent back order and the

company is releasing supplies as they become available.



Fresenius Kabi has ondansetron 2 mg/mL 20 mL vials on back order and the company estimates a

release date of early-April 2019. There are short-dated 20 mL vials available with an expiration date

of < 2 months.

Hikma has ondansetron 2 mg/mL 20 mL vials in 10 count on back order and the company estimates a

release date of April to May 2019.

Pfizer has ondansetron 2 mg/mL 2 mL iSecure syringes on back order and the company estimates a

release date of December 2019. The 2 mg/mL 20 mL vials are on back order and the company

estimates a release date in September 2019.

Sagent has ondansetron 2 mg/mL 2 mL vials and 20 mL vials on back order and the company cannot



Potassium Phosphate Injection

March 18, 2019


American Regent has not had potassium phosphate injection available since 2012. It is unclear if and

when product will return to market.

Fresenius Kabi had potassium phosphate injection on shortage due to increased demand.

Pfizer had potassium phosphate injection on shortage due to manufacturing delays.


Pfizer has potassium phosphate 3 mmol/mL 15 mL vials available in limited supply.


Ropivacaine Injection

March 18, 2019


Akorn has ropivacaine on shortage due to increased demand.


Fresenius Kabi has Naropin on shortage due to increased demand and manufacturing delays.

Pfizer had ropivacaine on shortage due to manufacturing delays.


Akorn has ropivacaine 5 mg/mL 30 mL vials on back order and the company cannot estimate a

release date.

AuroMedics has ropivcaine 7.5 mg/mL 20 mL vials and 5 mg/mL 30 mL vials on intermittent back

order and the company is releasing product as it becomes available.

Fresenius Kabi has Naropin 5 mg/mL 30 mL Steripak ampules on back order and the company

estimates a release date of mid-May 2019. The 5 mg/mL 100 mL bottles are on back order and the

company estimates a release date of late-March 2019. Check wholesalers for inventory.

Pfizer has ropivacaine 2 mg/mL 10 mL and 20 mL vials, 5 mg/mL 30 mL vials and 7.5 mg/mL 20 mL

vials, and 10 mg/mL 10 mL and 20 mL vials on back order and the company estimates a release date

of July 2019.




Levothyroxine Sodium Injection

March 19, 2019


Athenex started marketing levothyroxine sodium in January 2019

Fresenius Kabi has levothyroxine sodium available.

Par had levothyroxine sodium on shortage due to increased demand.

Piramal Critical Care did not provide a reason for the shortage.


Piramal Critical Care has levothyroxine 100 mcg vials on back order and the company cannot



Abciximab Injection

March 20, 2019


Janssen has Reopro on shortage due to a production interruption at their third party manufacturing

site. The contract manufacturer cannot guarantee supply continuity in 2018 and beyond.

There are no other suppliers of abciximab.


Janssen has Reopro on long-term back order and the company cannot estimate a release date.


Ampicillin Sodium and Sulbactam Sodium Injection

March 20, 2019


Pfizer has discontinued generic ampicillin sulbactam except for the 1.5 gram and 3 gram ADD-

Vantage vials.

Sagent has ampicillin sulbactam vials on back order due to manufacturing delays and increased

demand.

Sandoz cannot provide a reason for the shortage.

WG Critical Care states the shortage is due to increased demand.


AuroMedics has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order


Fresenius Kabi has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order


Hikma has ampicilin sulbactam 15 gram vials on back order and the company estimates a release

date of mid-April to mid-May 2019. The 1.5 gram and 3 gram vials are on allocation.

Mylan Institutional has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on back order and

the company estimates a release date of mid-April 2019 for the 1.5 and 3 gram vials and mid-May

2019 for the 15 gram vials.



Pfizer has Unasyn 1.5 gram vials and 3 gram vials on back order and the company estimates a release

date of June 2019 for the 1.5 gram vials and March 2019 for the 3 gram vials. Unasyn 15 gram bulk

vials are on back order and the company estimates a release date of March 2020.

Sandoz has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order and


Sagent has ampicillin sulbactam 1.5 gram vials and 15 gram bulk vials on back order and the

company estimates a release date of March 2019. The 3 gram vials are on back order and the

company estimates a release date of May 2019.

WG Critical Care has ampicillin sulbactam 1.5 gram and 3 gram vials on back order and the company

estimates a release date of late-May 2019. The 15 gram bulk vials are on back order and the



Diclofenac Sodium 1% Topical Gel

March 20, 2019



Cipla USA has diclofenac 1% topical gel available.

Endo did not provide a reason for the shortage.

Par did not provide a reason for the shortage.


Amneal has diclofenac 1% topical gel in 100 gram tubes on back order and the company estimates a

release date in early-April 2019.

Endo has diclofenac 1% topical gel in 20 gram and 100 gram tubes on back order and the company


Par has diclofenac 1% topical gel in 100 gram tubes on back order and the company estimates a

release date in late-March 2019.


Exenatide Extended-Release Suspension for Injection

March 20, 2019


AstraZeneca has Bydureon BCise on shortage due to increased demand.

AstraZeneca has Bydureon Pen available.


AstraZeneca has Bydureon BCise on intermittent back order and the company is releasing supplies as

they become available. The company expects this to be a short-term issue.




Heparin Injection

March 20, 2019


Fresenius Kabi has heparin on shortage due to increased demand.


Mylan has heparin presentations available.


Sagent has heparin on shortage due to manufacturing issues and increased demand.


Fresenius Kabi has heparin 1,000 unit/mL 2 mL and 10 mL vials on back order and the company

estimates a release date of early-April 2019 for the 2 mL vials and late-March 2019 for the 10 mL

vials. The 5,000 unit/mL 10 mL and 10,000 unit/mL 5 mL vials are on back order and the company

estimates a release date of mid- to late-March 2019 for the 5,000 unit/mL 10 mL vials and mid-May

2019 for the 10,000 unit/mL 5 mL vials. The 10,000 unit/mL 4 mL vials are on back order and the


Hikma has 1,000 unit/mL 30 mL vials and 5,000 unit/mL 10 mL vials on back order and the company

cannot estimate a release date. The 1,000 unit/mL 2 mL vials are on back order and the company

estimates a release date of March to April 2019.

Mylan has 5,000 unit/mL 1 mL vials on back order and the company estimates a release date in mid-

May 2019.

Pfizer has 5,000 unit/mL 1 mL Carpuject syringes on back order and the company estimates a release

date of December 2019. The 1,000 unit/mL 10 mL and 5,000 unit/mL 10 mL vials are on back order

and the company cannot estimate a release date. The 1,000 unit/mL 1 mL glass vials, 5,000 unit/mL 1

mL glass vials, and 10,000 unit/mL 1 mL glass vials are on back order and the company estimates a

release date of June 2019. The 10,000 unit/mL 0.5 mL carpuject syringes are on back order and the

company estimates a release date in April 2019. The 1,000 unit/mL 30 mL glass vials are on back

order and the company estimates a release date in March 2019.

Sagent has 1,000 unit/mL 1 mL vials, 1,000 unit/mL 2 mL vials, 5,000 unit/mL 1 mL vials, and 10,000

unit/mL 4 mL vials on allocation. The 5,000 unit/mL 10 mL vials and 10,000 unit/mL 1 mL vials are on

back order and the company estimates a release date of May 2019.


Hydroxyzine Pamoate Oral Capsules

March 20, 2019





Rising discontinued hydroxyzine pamoate capsules.






Amneal has hydroxyzine pamoate capsules on back order and the company estimates a release date

in early-April 2019.

Mylan has hydroxyzine pamoate 25 mg and 50 mg capsules in 100 count unit dose packages on back

order and the company estimates release dates in early-June 2019 for the 25 mg capsules and early-

May 2019 for the 50 mg capsules.

Pfizer has Vistaril 25 mg and 50 mg capsules in 100 count bottles on back order and the company

estimates a release date in late-March 2019.

Sandoz has hydroxyzine pamoate 50 mg capsules on back order and the company estimates a

release date in late-March 2019.

Teva has hydroxyzine pamoate 25 mg, 50 mg, and 100 mg capsules on back order and the company

estimates a release date in late-June 2019.


Immune Globulin, Subcutaneous (Human)

March 20, 2019


Baxalta has HyQvia and Cuvitru on shortage due to increased demand.

CSL Behring has Hizentra available.


Baxalta has Cuvitru on allocation and the company is reviewing all orders.

Baxalta has HyQvia on allocation and the company is reviewing all orders.


Iopamidol Injection

March 20, 2019


Bracco Diagnostics is the sole supplier of iopamidol and did not provide a reason for the shortage.


Bracco Diagnostics has Isovue-300 (iopamidol 61%) in 75 mL, 200 mL, and 500 mL bottles on back

order and the company cannot estimate a release date. Isovue-300 in 50 mL vials are on back order

and the company estimates a release date in early-April 2019. Isovue 370 (iopamidol 76%) in 125 mL

bottles are on back order and the company cannot estimate a release date.


Methylene Blue

March 20, 2019


Akorn has methylene blue on shortage due to manufacturing delays. They are not currently

marketing the 1 mL vials.[1]


Akorn has methylene blue 10 mg/mL 10 mL vials on back order and the company cannot estimate a

release date.[1]




Nitrofurantoin Oral Suspension

March 20, 2019



Casper Pharma did not provide a reason for the Furadantin shortage.

Lupin is no longer manufacturing this product.

Nostrum has nitrofurantoin oral suspension available.



Amneal has nitrofurantoin oral suspension on back order and the company cannot estimate a

release date.

Casper has Furadantin oral suspension available with short expiration dating (May 2019).

Teva has nitrofurantoin oral suspension on back order and the company cannot estimate a release

date.


Nystatin Oral Suspension

March 20, 2019



Pharmaceutical Associates, Inc. did not provide a reason for the shortage.

Precision Dose has nystatin suspension on allocation due to increased demand.

Vista Pharma did not provide a reason for the shortage.

Wockhardt USA did not provide a reason for the shortage.


Akorn has nystatin 100,000 unit/mL suspension 60 mL and 473 mL bottles on back order and the


Pharmaceutical Associates, Inc. has all nystatin suspension presentations on allocation.

Precision Dose has all nystatin suspension presentations on back order and the company estimates a

release date in early-April 2019.

Vista Pharma has nystatin 100,000 units/mL suspension 60 mL bottles, 480 mL bottles, and 5 mL

unit-dose cups in 100 count on back order and the company cannot estimate release dates.

Wockhardt USA has nystatin 100,000 units/mL suspension 60 mL and 473 mL bottles on back order

and the company estimates a release date of late-March 2019 for the 60 mL bottles and early-April

2019 for the 473 mL bottles.




Tropicamide 1% Ophthalmic Solution

March 20, 2019



Alcon has Mydriacyl available.

Bausch Health discontinued tropicamide 1% ophthalmic drops in mid-2018.



Akorn has tropicamide 1% ophthalmic drops in 15 mL bottles on allocation.

Sandoz has tropicamide 1% ophthalmic drops in 3 mL bottles on back order and the company

estimates a release date in late-March 2019.


Fluconazole Injection

March 21, 2019


Hikma discontinued fluconazole injection in August 2018.

Pfizer has fluconazole injection on shortage due to manufacturing delays. The 200 mg/100 mL

fluconazole in dextrose bags were discontinued in August 2018.

Renaissance Lakewood Pharmaceuticals bought fluconazole in sodium chloride premixed bags from

Claris Lifescience.

Sagent has fluconazole injection on shortage due to increased demand and manufacturing delays.


Renaissance Lakewood has fluconazole 200 mg/100 mL in 0.9% sodium chloride in 10 count and 400

mg/200 mL in 0.9% sodium chloride in 6 and 10 count on back order and the company cannot

estimate release dates.

Sagent has fluconazole injection 200 mg/100 mL in 0.9% sodium chloride on allocation.


Multiple Vitamins for Infusion

March 21, 2019


Pfizer states the shortage is due to manufacturing delays.

Baxter has all presentations fully available at this time.


Pfizer has M.V.I. Adult 2 X 5 mL Dual vials, M.V.I. Adult 2 X 50 mL vials, and Pediatric 5 mL vials on

back order and the company estimates a release date of December 2019. There is limited short-

dated product available for the 50 mL adult vials and 5 mL pediatric vials.




Ranitidine Injection

March 21, 2019


Mylan has ranitidine injection available.

Teligent has Zantac IV on shortage due to production delays.

Zydus has ranitidine injection available.


Teligent has Zantac 25 mg/mL 2 mL, 6 mL, and 40 mL vials on back order and the company estimates

a release date of 2nd quarter 2019.


Vancomycin Hydrochloride Injection

March 21, 2019


Alvogen has vancomycin injection available.[1]

Athenex has vancomycin injection available.[2]

AuroMedics has vancomycin injection available.[3]

Pfizer has vancomycin vials on back order due to manufacturing delays.[4]

Fresenius Kabi has vancomycin injection on shortage due to increased demand.[5]

Mylan Institutional has vancomycin injection available.[6]

Baxter has vancomycin injection available.[7]

Samson Medical Technologies has vancomycin injection available.[8]

Sagent has vancomycin injection available.[9]

Xellia Pharmaceuticals has vancomycin injection available.[10]


Pfizer has 500 mg ADD-Vantage vials, 750 mg vials, 750 mg ADD-Vantage vials, 1 gram vials, and 10

gram vials available in limited supply. The 1 gram ADD-Vantage vials are on back order and the

company estimates a release date of April 2019. The 500 mg vials are on back order and the

company estimates a release date in March 2019.[4]


*Please refer to ASHP website for more information at: https://www.ashp.org/Drug-Shortages/Current-Shortages

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