Drug Information Update · 2018. 10. 25. · AMINOLEVULINIC ACID HCL 30 MG/ML New Dosage Form, New...

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Drug Information Update October 2018

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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 ............................................. 7

STUDIES AND RECENT TOPICS .............................................................................. 10

RECALLS ............................................................................................................... 15

CURRENT DRUG SHORTAGES ............................................................................... 31



NEWLY AVAILABLE GENERICS

GENERIC DRUG NAME STRENGTH &

DOSAGE FORM GENERIC

MANUFACTURER BRAND NAME

TESTOSTERONE

20.25 MG/1.25 GRAM PER

ACTUATION (1.62%) GEL

PUMP

PERRIGO CO. ANDROGEL

BALSAM PERU/CASTOR OIL 87 MG-788 MG/GRAM OINTMENT

CANTON LABORATORY

VENELEX

TADALAFIL 2.5 MG, 5 MG, 10 MG, 20 MG

TABLET TEVA, PRASCO LABS CIALIS

AMPHETAMINE SULFATE 5 MG, 10 MG

TABLET WILSHIRE

PHARMACEUTICALS EVEKEO

ALBENDAZOLE 200 MG CIPLA USA,

LINEAGE/IMPAX ALBENZA

LACTULOSE 10 GRAM PACKET

FOXLAND PHARMACEUTICAL

KRISTALOSE

MORPHINE SULFATE 40 MG CAPSULE IMPAX GENERICS KADIAN

BUPROPION HCL 450 MG TABLET ALVOGEN INC FORFIVO XL

CARMUSTINE 100 MG VIAL ZYDUS

PHARMACEUTICALS BICNU

ITRACONAZOLE 10 MG/ML SOLUTION

PATRIOT PHARMACEUTICALS

SPORANOX



NEW DRUG ENTITIES/COMBINATIONS/STRENGTHS

DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

AMINOGLYCOSIDE ANTIBIOTICS

ARIKAYCE AMIKACIN

LIPOSOMAL/NEB.ACCESSR

590 MG/ 8.4 ML

New Dosage Form, New

Strength

FLUORESCENCE IMAGING AGENTS - MALIGNANT

TISSUE GLEOLAN

AMINOLEVULINIC ACID HCL

30 MG/ML New Dosage Form, New

Strength

ANTINEOPLASTICS,MISCELLANEOUS

ARSENIC TRIOXIDE

ARSENIC TRIOXIDE 10 MG/ 10 ML

Vial, previously available in

ampule

ANTICONVULSANT - CANNABINOID TYPE

EPIDIOLEX CANNABIDIOL (CBD)

EXTRACT 100 MG/ML New Entity

ANTINEOPLASTIC,ANTI-PROGRAMMED DEATH-1

(PD-1) MAB LIBTAYO CEMIPLIMAB-RWLC

350 MG/7ML

New Entity

ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS

VIZIMPRO DACOMITINIB 15 MG New Entity





ANTIDIURETIC AND VASOPRESSOR HORMONES

NOCDURNA DESMOPRESSIN

ACETATE 25 MCG


Strength

ANTIDIURETIC AND VASOPRESSOR HORMONES

NOCDURNA DESMOPRESSIN

ACETATE 50 MCG


Strength

ANTIMIGRAINE PREPARATIONS

EMGALITY GALCANEZUMAB-GNLM 120 MG/ML New Entity

OPIOID ANALGESICS DILAUDID HYDROMORPHONE

HCL/PF 0.5 MG/ 0.5ML

GCN Change preservative

free see table below

TOPICAL ANTIBIOTICS XEPI OZENOXACIN 1% New Entity

VITAMIN A DERIVATIVES ALTRENO TRETINOIN 0.05% New Dosage

Form

AMYOTROPHIC LATERAL SCLEROSIS AGENTS

TIGLUTIK RILUZOLE 50 MG/ 10 ML

New Dosage Form

VAGINAL ESTROGEN FOR SEXUAL DYSFUNCTION

IMVEXXY ESTRADIOL 10 MCG GCN change

VAGINAL ESTROGEN FOR SEXUAL DYSFUNCTION

IMVEXXY ESTRADIOL 4 MCG GCN change



DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

TOPICAL HEMOSTATICS GEL-FLOW THROMBIN,BOVINE/GEL

ATIN SPONGE 5000 UNIT

New Dosage Form

EMOLLIENTS CERAMAX EMOLLIENT

COMBINATION NO.101 N/A

New Dosage Form

EYE ANTI-INFLAMMATORY AGENTS

PREDNISOLONE PHOS-

BROMFENAC

PREDNISOLONE SOD PH/BROMFENAC

1 %-0.075% New Entity

ARTIFICIAL TEARS KLARITY

(CHONDROITIN)

CHONDROITIN SULF A SODIUM/PF

0.25% New Entity

INFLUENZA VIRUS VACCINES

EZ FLU 2018-2019

(FLUCELVAX)

FLU VAC QS 18-19(4YR UP)CEL/PF

60 MCG/ 0.5ML

New Dosage Form; kit

IRRITANTS/COUNTER-IRRITANTS

CANTHARIDIN-ACETONE

CANTHARIDIN IN ACETONE

0.70% New Entity

ANTIMIGRAINE PREPARATIONS

AJOVY FREMANEZUMAB-VFRM 225 MG/ 1.5 ML

New Entity

PROTECTIVES SILIPAC DIME/DIME CR/ TRIMETH/SILIC

PAD N/A

Medical Device

TOPICAL LOCAL ANESTHETICS

ZTLIDO LIDOCAINE 1.80% New

Strength

ANTIVIRALS, HIV SPECIFIC, NONNUCLEOSIDE,

RTI PIFELTRO DORAVIRINE 100 MG New Entity

ARTV NUCLEOSIDE, NUCLEOTIDE,

NONNUCLEOSIDE RTI COMB

DELSTRIGO

DORAVIRINE/ LAMIVUDINE/

TENOFOVIR DISOPROXIL

100 MG‐ 300 MG‐ 300 MG

New Combination


COPIKTRA DUVELISIB 15 MG New Entity


COPIKTRA DUVELISIB 25 MG New entity

TETRACYCLINE ANTIBIOTICS XERAVA ERAVACYCLINE DI-HYDROCHLORIDE

50 MG New Entity

TETRACYCLINE ANTIBIOTICS MINOLIRA ER MINOCYCLINE HCL 105 MG New Dosage

Form

TETRACYCLINE ANTIBIOTICS MINOLIRA ER MINOCYCLINE HCL 135 MG New Dosage

Form

ANTIEMETIC/ANTIVERTIGO AGENTS

PALONOSETRON HCL

PALONOSETRON HCL 0.25 MG/

5 ML

Syringe, previously

only marketed in vial



NEW INDICATIONS (EXISTING DRUGS)

XARELTO®

October 11, 2018

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

Drug Administration (FDA) has approved XARELTO® (rivaroxaban) to reduce the risk of major

cardiovascular (CV) events, such as CV death, myocardial infarction (MI) and stroke, in people with

chronic coronary or peripheral artery disease (CAD/PAD). XARELTO® is now the first and only Factor Xa

inhibitor approved for patients living with these conditions.

Source: Janssen Pharmaceutical Companies of Johnson & Johnson

IXIARO®

October 5, 2018

Valneva SE ("Valneva" or "the Company"), a commercial stage biotech company focused on developing

innovative lifesaving vaccines, announced today that the U.S. Food and Drug Administration (FDA) has

approved an alternate IXIARO® immunization schedule of two doses administered seven days apart for

adult travelers aged 18-65 years old. This accelerated schedule comes in addition to the previously

approved schedule.

Source: Valneva SE

HEMLIBRA®

October 4, 2018

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

U.S. Food and Drug Administration (FDA) has approved Hemlibra® (emicizumab-kxwh) for routine

prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages

newborn and older, with hemophilia A without factor VIII inhibitors. Hemlibra is now the only

prophylactic treatment for people with hemophilia A with and without factor VIII inhibitors that can be

administered subcutaneously (under the skin) and at multiple dosing options (once weekly, every two

weeks or every four weeks). This approval is based on positive results from the Phase III HAVEN 3 and

HAVEN 4 studies. Hemlibra prophylaxis led to statistically significant and clinically meaningful reductions

in treated bleeds compared to no prophylaxis (primary endpoint) and across all other bleed-related

endpoints in the HAVEN 3 study, and showed a clinically meaningful control of bleeding in the HAVEN 4

study.

Source: Genentech



XOLAIR®

September 28, 2018

Novartis announced today that the US Food and Drug Administration (FDA) has approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes (PFS) for Xolair® (omalizumab) as an additional formulation for both allergic asthma and chronic idiopathic urticarial (CIU) indications2. The new Xolair PFS formulation is expected to be available by the end of this year for the first time in the US. Xolair is currently available in a 150 mg single-dose vial with lyophilized, sterile powder for reconstitution. Source: Novartis FYCOMPA® September 28, 2018 Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) expanded the indication of its antiepileptic drug FYCOMPA® (perampanel) CIII for monotherapy and adjunctive use in pediatric patients 4 years and older for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures. The approval includes both FYCOMPA tablet and oral suspension formulations. Source: Eisai Inc. SYMJEPI® September 27, 2018 Adamis Pharmaceuticals Corporation (“Adamis”) today announced that the U.S. Food and Drug Administration (“FDA”) has approved Adamis’ lower dose version (0.15mg) of Symjepi ™ for the emergency treatment of allergic reactions (Type I) including anaphylaxis. Source: Adamis Pharmaceuticals Corporation



FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc. [Posted 10/10/18] Liveyon, LLC (“Liveyon”) is a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA. Liveyon marketed and distributed these products under the trade name ReGen Series®. Liveyon has voluntarily recalled all ReGen Series® products due to reported possible adverse reactions. The Center for Biologics Evaluation and Research (CBER), a division of the Food & Drug Administration (FDA), which oversees human cells and tissue-based products, contacted Liveyon on Thursday, September 28, 2018. CBER stated concerns related to the products manufactured by Genetech and informed Liveyon of reported possible adverse reactions due to the use of the ReGen Series® product. Liveyon immediately suspended shipment of all product pending an inquiry by CBER into the source of the adverse reactions. In addition, Liveyon voluntarily recalled any Genetech products it may have distributed. Working closely with the FDA, Liveyon has executed a strategic recall action plan and has immediately begun the voluntary recall process. The decision to stop shipment of Genetech products and implement the recall was to ensure the safety of all patients, regardless of whether the adverse reactions were product- related or the result of any procedural misuse of the product. Liveyon immediately discontinued the purchase any product from Genetech and has procured new product from an alternative manufacturer. Liveyon has secured a manufacturer which has been in business for more than 15 years and manufactures the new product in a cGMP compliant facility. The new manufacturer is a US-based, FDA registered, fully licensed and compliant umbilical cord blood/tissue bank accredited by the America Association of Blood Banks (AABB). It is a member of the Be The Match Program and has passed all FDA inspections. Liveyon will resume distribution of the new product line effective Monday, October 8, 2018. Source: U.S. Food and Drug Administration (FDA) Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label [Posted 09/28/2018] Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see picture below for location of incorrect text).



Patients who follow the directions on the bottle may experience significant drowsiness or dizziness which would put them at risk of falls or an overdose which could result in seizures, coma, or death. To date, Endo Pharmaceuticals Inc. has not received any reports of adverse events related to this recall. Robaxin® 750mg Tablets contain the active ingredient methocarbamol and are indicated as an adjunct therapy to rest, physical therapy and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. Robaxin® 750mg Tablets are packed in bottles of 100 tablets with package labelingfeaturing the product name, strength, lot number, expiry date and the National Drug Code number NDC 52244-449-10. The recall includes the following product lots:

Robaxin® 750mg, 100 Count Bottle pack, Lot 216702P1, Expiration Date: September 2020; and

Robaxin® 750mg, 100 Count Bottle pack, Lot 220409P1, Expiration Date: January 2021. No other lots of Robaxin® are affected by this market action. Robaxin® 750mg 100 Count Bottle packs were distributed by wholesale distributors to retail pharmacies. Endo Pharmaceuticals Inc. is notifying distributors and retailers in writing through Inmar, Inc. Inmar is arranging for return of all recalled products. Distributors and retailers that have product which is being recalled should stop distributing and dispensing and return to the place of purchase. Consumers in possession of any unused prescribed Robaxin® 750mg product bearing lot numbers 216702P1 or 220409P1 should discontinue use of the product and return the unused product by following the instructions below:

Please contact Inmar at 1-866-391-0620, Monday through Friday (9am to 5pm ET) or email [email protected] for the following:

o Product Return Upon contacting Inmar and indicating you have unused product, please expect

Return Authorization labels and Shipping instructions. o Product Reimbursement

Upon contacting Inmar, please be prepared to share proof of purchase.

Proof of purchase can be sent to [email protected] or 635 Vine St.Winston Salem, NC 27101-Attention Recall Department, Robaxin Recall.

Distributors, retailers and consumers with questions regarding this recall can contact Inmar by telephone at 1-866-391-0620 during the following hours: Monday through Friday (9am to 5pm ET) or by email at [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 associated with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either by phone, on line, 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 Product Recall is being made with the knowledge of the United States Food and Drug Administration (FDA). Endo Pharmaceuticals Inc. takes this issue seriously and works to achieve high quality standards for all of its products and packaging. If you have any questions, please call 1-800-462-ENDO (3636), between the hours of 8:00 a.m. to 8:00 p.m. ET Monday through Thursday and 8:00 a.m. to 6:00 p.m. ET on Friday. Additional information regarding this recall can be found at http://www.endo.com/endopharma/our-products. Source: U.S. Food and Drug Administration (FDA)



STUDIES AND RECENT TOPICS

In worrying trend, vaccination rates in U.S. children keep dropping: CDC reports October 16, 2018 While immunization rates among young children in the U.S. remain high, the percentage who haven't received recommended vaccines has been growing, and so have vaccine exemption rates, the CDC says. In a recent report, the CDC found that the percentage of 2-year-olds who'd received no vaccinations grew to 1.3% among those born in 2015, up from 0.9% for those born in 2011. Meanwhile, the median rate of kindergarten children with a vaccine exemption has also risen—for the third year in a row—to reach 2.2%, the CDC said in another study. Source: fiercepharma.com Cost of blood pressure drug surges in U.S. after recall October 16, 2018 NEW YORK (Reuters) - Prices for two dosages of the blood pressure drug valsartan rose more than any other drug in the United States in September, following a recall of much of the drug’s supply. Chinese pharmaceutical ingredient manufacturer Zhejiang Huahai Pharmaceuticals recalled valsartan from consumers in the United States in July after finding traces of a probable carcinogen. Source: reuters.com Xanax, Valium Tied to Higher Suicide Risk in COPD Patients With PTSD October 16, 2018 People suffering from two common conditions -- post-traumatic stress disorder (PTSD) and the breathing disorder known as chronic obstructive pulmonary disease (COPD) -- may be increasing their risk for suicide if they take benzodiazepine drugs, a new study suggests. Source: healthday.com FDA mandates pediatric trials for 200 cancer targets October 16, 2018 In a move to spur development of drugs for pediatric populations and require more studies of pediatric cancers, FDA published Tuesday a list of 200 molecular targets for which companies developing directed compounds must conduct pediatric clinical studies. The requirement applies even if the compound has Orphan Drug designation for the pediatric population, or if the adult indication does not occur in children. Source: biocentury.com



Teva's patent failure gives long-acting Copaxone generics free rein October 15, 2018 Teva's strategy for padding its Copaxone franchise even in the face of generic competition just took a major hit. The company lost its bid to defend the long-acting, 40mg version of the multiple sclerosis drug—the very product taking up the slack as copycats to the short-acting formula steal share. Source: fiercepharma.com Despite Opioid Crisis, Most Patients Want the Drugs for Post-Op Pain October 15, 2018 Despite a flood of news reports on the opioid crisis, many people still want the potentially addictive painkillers after surgery, a new survey suggests. The survey, of more than 500 patients scheduled for surgery, found that more than three-quarters expected to get opioids afterward. Most also thought opioids were the most effective treatment for post-surgery pain. Source: consumer.healthday.com Amoxicillin Therapy Effective for Treating Inflammatory Acne October 11, 2018 Amoxicillin was effective in treating inflammatory acne in patients with refractory disease, according to a study published in the International Journal of Women's Dermatology. Researchers performed a retrospective chart review to analyze the efficacy and safety of systemic amoxicillin on inflammatory acne. All 26 patients involved in this study had unsatisfactory results using topical medication, hormone therapy, and/or isotretinoin for at least 12 weeks. In addition, 84.6% experienced no benefit from another antibiotic, 11.5% were allergic to sulfonamides, and 11.5% had undesirable antibiotic side effects. These patients added amoxicillin to their current treatment, and researchers used the Comprehensive Acne Severity Scale to complete pre- and post-treatment evaluations. Source: dermatologyadvisor.com FDA staff raises safety issues over Trevena opioid injection October 9, 2018 Trevena’s opioid injection to treat acute pain could be abused and potentially lead to overdose, staff reviewers of the U.S. Food and Drug Administration said on Tuesday, sending the drugmaker’s shares down 66 percent. Source: reuters.com



FDA reviewers endorse Celltrion's Rituxan biosimilar ahead of panel vote October 9, 2018 Celltrion’s biosimilar to Roche’s blockbuster Rituxan has already been rejected at the FDA once for manufacturing problems, but in the company’s second attempt, agency staffers have reacted favorably to the med. In a review document (PDF) posted ahead of an FDA panel meeting set for Wednesday, internal reviewers found no “clinically meaningful differences … in terms of safety, purity and potency” between the biosim and Roche drug. Source: fiercepharma.com Flu drug speeds relief from symptoms in at-risk patients: Roche October 4, 2018 Influenza drug baloxavir marboxil significantly sped time to relief for patients highly vulnerable to serious complications, a late-stage clinical trial has shown, Swiss drugmaker Roche said on Thursday. Source: reuters.com Merck runs out of Parkinson’s disease drug Sinemet as manufacturing issues, forecasting miss lead to shortage October 3, 2018 Merck & Co. is out of stock and dealing with back orders of some of its Sinemet Parkinson’s disease drug products that won't be resolved until next year. The issues have resulted from manufacturing problems at the CMO that produces the drug for Merck, and because the drugmaker badly missed its forecast for demand. Source: fiercepharma.com FDA looks for ideal way to convey risk info in drug ads October 2, 2018 Important Safety information or brief summary? The FDA wants to test which is ideal for conveying risk info in prescription drug ads. In light of the existing evidence on risk, that may be a moot question, some experts contend. In August, the FDA submitted a proposal to conduct a pair of studies, each with 200 participants, that would use eye-tracking tech to determine how consumers process risk info in DTC print ads. The goal involves seeing how subjects’ attention to risk info fluctuates depending on its inclusion in the important safety information section or consumer brief summary. Including info in both may have advantages, the FDA said in a statement, noting research indicating “repetition improves recall, especially for older adults.” However, a 2002 FDA survey found “it is possible risks appearing on the main page in the important safety information may be more likely to be read than risks appearing in the brief summary.” Source: mmm-online.com



UW Health researches medical use for psychedelics September 29, 2018 Alan Ferguson’s depression became so severe this spring, he quit his job, gave away his dog and planned to end his life. None of the medications he had tried eased his despair. A psychiatrist suggested one last treatment: ketamine, an anesthetic known as “special K,” a party or date rape drug. Source: apnews.com GW Pharma cannabis drug set to hit market following DEA nod September 27, 2018 U.S.-listed shares of GW Pharmaceuticals rose 8 percent on Thursday as its marijuana-based treatment Epidiolex cleared the last hurdle after the Drug Enforcement Administration labeled the drug as having a low abuse potential. The company said it would bring the drug to the market within the next six weeks. Source: reuters.com Big Pharma's antibody drugs for asthma show benefits but cost 50% too much: ICER September 26, 2018 New antibody-based treatments are better than traditional drugs for moderate to severe asthma, but they still cost too much, a U.S. drug cost watchdog says. More than 50% too much, in fact. In a new draft report (PDF), the Institute for Clinical and Economic Review (ICER) evaluated five biologic drugs in inflammatory or allergic asthma: GlaxoSmithKline’s Nucala; Teva’s Cinqair; Roche and Novartis’ Xolair; AstraZeneca’s Fasenra; and Sanofi and Regeneron’s Dupixent. Source: fiercepharma.com Big Pharma Boosts Drug Prices As Supplies Run Low, Study Reveals September 26, 2018 Federal lawmakers have been griping about drug pricing for years, led most recently by President Donald Trump, who famously declared even before he was elected that the industry is “getting away with murder.” A new study could very well fuel those complaints. Source: forbes.com How Digital Health Could Transform the Fight Against the Opioid Crisis September 26, 2018 America’s battle with opioid addiction is an uphill one. But a mix of innovation in digital health and good, old fashioned medicine could help us fight it, according to a top pharmaceutical executive. “In over 20 years, we haven’t had new innovations in the pain space. Right now, opioids are the most effective for acute pain relief. But they’re not meant for chronic pain,” said Christi Shaw, senior vice president of Eli Lilly and president of the drug giant’s Bio-Medicines unit, during the Fortune Brainstorm Reinvent conference in Chicago Tuesday.



Source: fortune.com Drug shortages may add $230 million to annual U.S. drug costs September 21, 2018 Prescription drug shortages may drive up prices twice as much as they would rise with medicines in abundant supply, adding $230 million a year to U.S. drug costs, a new study estimates. Researchers examined data on 90 medications involved in shortages between December 2015 and December 2016. They compared average wholesale drug prices for 11 months before and after shortages began, and they also looked at a decade of historical price increases. Source: reuters.com With CDC backing reinstated, AstraZeneca ships FluMist for the coming flu season September 26, 2018 Having missed two flu seasons, AstraZeneca is looking to a comeback in the U.S. with its nasal spray flu vaccine FluMist Quadrivalent on the back of CDC vaccine advisory group endorsement. But supply is limited. The British Pharma announced on Tuesday that it has shipped FluMist for the 2018-19 season, more than a month after Sanofi, Seqirus and GlaxoSmithKline sent their first batches. It has manufactured 2.7 million doses for the U.S. in this season, Lily Cappelletti, a company media aide, told FierceVaccines. That's far fewer than its peers. Source: fiercepharma.com FDA clears Parkinson's disease drug from Acadia of new safety concerns September 20, 2018 A Parkinson’s disease drug from San Diego’s Acadia Pharmaceuticals provides more benefits than risks and has no new safety concerns, the U.S. Food and Drug Administration said Thursday. Source: sandiegouniontribune.com



RECALLS

Product Type

Product Description

Classification

Code Info Reason for Recall Recalling

Firm

Drug

Norepinephrine 4 mg (16 mcg/mL)

added to 5% Dextrose 250 mL Bag Preservative

Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ

08804, UPC 70092103417.

Class I Lot

#:30000271, Exp 10/1/18

Subpotent Drug: Product may not have the active ingredient

present in the bag.

QuVa Pharma,

Inc.

Drugs

robaxin-750 (methocarbamol tablets, USP), 750

mg, 100-count bottle, Rx Only, Distributed by:

Endo Pharmaceuticals Inc., Malvern, PA

19355; Manufactured by:

Kremers Urban Pharmaceuticals Inc., a subsidiary

of Lannett Company, Inc.,

Seymour, IN 47274; NDC

52244-449-10.

Class I

Lot #: 216702P1, Exp 09/20; 220409P1, Exp 01/21

Labeling: Incorrect Instructions: Dosage information on the immediate container label

incorrectly states "Two to four tablets four times daily." rather

than the correct dosage of "Two tablets three times daily."

Endo Pharmaceuticals,

Inc.

Drug

Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By:

Dr. Reddy's Laboratories

Limited Srilakulam - 532 409 INDIA, NDC 55111-179-

15, UPC 35511179153

Class II

Lot #: T800304,

Exp. 03/2021

Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of

Tinzadine Hcl Tablets .

Dr. Reddy's

Laboratories, Inc



Product Type

Product Description

Classification


Firm

Drug

Skin Irritation & Itch Response Homeopathic

Formula, 2 FL. OZ. (59.2 mL) per

amber glass oral spray bottle,

Distributed by Beaumont Bio-

Med, Inc., Waukon, IA 52172; NDC

58066-7002-7

Class II

Lot: 091515C,

Exp 09/2018; 050118S,

Exp 05/2021

CGMP Deviations: products manufactured by contract

manufacturer under conditions that could result in possible

microbial contamination.

Beaumont Bio-

med, Inc.

Drug

Sinus Response Homeopathic

Formula, 2 FL. OZ. (59.2 mL) per

amber glass oral spray bottle,

Distributed by Beaumont Bio-


58066-7013-7

Class II Lot:

100316A, Exp 10/2019



microbial contamination

Beaumont Bio-

med, Inc.

Drug

Sore Throat & Laryngitis Response

Homeopathic Formula, 2 FL. OZ.

(59.2 mL) per amber glass oral

spray bottle, Distributed by Beaumont Bio-


58066-7014-7

Class II

Lot: 100316G,

Exp 10/2019; 050118R,

Exp 05/2021




Beaumont Bio-

med, Inc.

Drugs

Diarrhea Response



Class II Lot:

090915A, Exp 09/2018




Beaumont Bio-

med, Inc.



Product Type

Product Description

Classification


Firm



58066-7022-7

Drugs

Muscle & Joint Pain Relief





58066-7041-7

Class II Lot:

012916F, Exp 01/2019




Beaumont Bio-

med, Inc.

Drugs

Allergy & Hay Fever Relief





58066-7011-7

Class II Lot:

050216X, Exp 05/2019




Beaumont Bio-

med, Inc.

Drugs

Colds & Flu Response





Class II

Lot: 042816C,

Exp 04/2019; 112317K,

Exp 11/2020




Beaumont Bio-

med, Inc.



Product Type

Product Description

Classification


Firm

58066-7012-7

Drugs

Arthritis Pain Relief





58066-7042-7

Class II Lot:

012916E, Exp 01/2019




Beaumont Bio-

med, Inc.

Drugs

0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter

Healthcare Corporation Deerfield, IL

60015 -- NDC 0338-0049-31

Class II

Lot: P380063

Exp. 12/2019

cGMP Deviation

Baxter Healthcar

e Corporati

on

Drugs

Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per

bottle, Rx Only, Manufactured in

INDIA, For: TORRENT

PHARMA INC., 150 Allen Road, Suite

102, Basking Ridge, NJ 07920. NDC: 13668-342-

30

Class II Lot:

BFR5D002 EXP 11-2019

Failed Dissolution Specifications: Out of

Specification for Dissolution test (Buffer Stage) at the 5-

hour time point during stability testing

Torrent Pharma

Inc.

Drugs

Synjardy (empagliflozin and

metformin hydrochloride)

Tablets. 5 mg/1000 mg. Rx only. 180-count

bottle. Distributed

Class II Lot #

603968 EXP 4/2019

Cross Contamination With Other Products:

Boehringer

Ingelheim

Pharmaceuticals,

Inc.



Product Type

Product Description

Classification


Firm

by: Boehinger Ingelheim (BI)

Pharmaceuticals, Inc. Ridgefield, CT 06877. Made in

Germany. Marketed by: BI

Pharmaceuticals, Inc. Ridgefield, CT 06877 and Eli Lilly

and Company Indianapolis IN

46285 NDC 0597-0175-18

Drugs

Minivelle (estradiol

transdermal system) Patches

Delivers 0.1 mg/day, a) 2

count and b) 8 count boxes, Rx only, , Mfd. by:

Noven Pharmaceuticals,

Inc. Miami, Florida 33186 Dist. By:

Noven Therapeutics, LLC.

Miami, Florida 33186 --- NDC 68968-6610-8

Class II

a) 82200 Exp.

01/2019 b) 81637 Exp. 10/2018;

82200 Exp. 01/2019;

82293 Exp. 02/2019;

82600 Exp. 04/2019;

83027 Exp. 04/2019;

83173 Exp. 06/2019;

83396 Exp. 09/2019

Defective Delivery System: out of specification results for

shear, an attribute related to the adhesive properties of the

transdermal patches.


Inc.

Drugs


transdermal system) Patches,

Delivers 0.05 mg/day, a) 2

count and 8 count boxes, Rx only, Mfd. by: Noven

Pharmaceuticals, Inc. Miami, Florida

33186 Dist. By: Noven

Class II

a) 82292 Exp.

02/2019; b) 82139 Exp. 10/2018;

82292 Exp. 02/2019;

and 82598 Exp.

04/2019





Inc.



Product Type

Product Description

Classification


Firm

Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6650-8

Drugs



Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven




Class II

Lots: 82199 Exp.

12/2018; 83025 Exp.

05/2019





Inc

Drugs



Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven




Class II

Lots: 82599 Exp.

05/2019; 82660 Exp. 03/2019;

83396 Exp. 09/2019





Inc.

Drugs

Montelukast Sodium Tablets,

10 mg*, 30-count bottles, Rx Only,

By: Hetero, Hetero Labs

Limited, Unit V, Polepally,

Class II Lot #:

MON17355, Exp 12/19

Discoloration: A complaint was received from a pharmacist for the presence of blue specks on

tablets

Hetero Labs

Limited Unit V Unit V

(SEZ Unit I in APIIC SEZ) Surv.



Product Type

Product Description

Classification


Firm

Jadcherla, Mahaboob Nagar - 509 301, India,

Manufactured for: Camber

Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.

Drugs

Thyroid Powder 25kg/drum, US

Pharmacopoeia, Sichuan Friendly Pharmaceutical

Co., LTD, Production

Address: No. 680, Hongpai Road,

Dongxing District, Neijiang City

Sichuan, China Tel:+886 832

2240082/2240298. NDC 7807-0170-

11

Class II

All lots to include 160601, 160602, 160603, 160801, 161101, 162011, 170301, 170501, 170502,

170701, and 170702

CGMP Deviations: Thyroid Powder has inconsistent levels

of the active ingredients levothyroxine and liothyronine.

Sichuan Friendly Pharmaceutical Co.,Ltd.

Drugs

NeoRelief for Muscle Cramping

& Restlessness Homeopathic Topical Gel,

packaged in a) 4 ml sample packs

and b) Net Wt. 2.0 oz (56.7g) bottles,

BioLyte Laboratories -

Grand Rapids, MI 49534, NDC

58368-002-02

Class II

Lot #: a) 1146, Exp

3/29/20; b) 1138, 1139,

Exp 1/31/20;

and 1160, Exp

10/10/19

CGMP Deviations: finished product produced with active

ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially

affect the quality of this product.

BioLyte Laborator

ies, LLC

Drugs

Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only,

Distributed by

Class II Lot S91616

Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection.

The entire cap either lifted or dislodged while attempting to flip off the orange color plastic

Pfizer Inc.



Product Type

Product Description

Classification


Firm

Pfizer Labs, Division of Pfizer

Inc, NY, NY 10017, NDC 0069-0106-

01

button.

Drugs

Clozapine Orally Disintegrating

Tablets, 12.5 mg, 100-count bottles,

Rx only, Teva Pharmaceuticals USA, Inc., North

Wales, PA 19454, NDC 0093-5416-01 Yellow, round,

flat-faced, beveled-edge,

unscored tablet. Debossed with 13 on one side and

plain on the other side.

Class II Lot #:

34034024B, Exp 02/20

Failed Disintegration Specifications: Out-of-

specification disintegration test result obtained during routine

stability testing.

Teva Pharmaceuticals

USA

Drugs

Nystatin and Triamcinolone

Acetonide Cream, USP, 100,000 units/gm & 1

mg/gm, packaged in a) 15 g tube

(NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-

60), Rx only, Distributor: Dr.

Reddy's Laboratories, Inc. 107 College Road

East, Princeton, NJ - 08540 Rx Only

Made inIndia

Class II

Lot #: a) D06017,

D06018, Exp 9/18;

D06028 Exp 10/18; b) D06014, D06015,

D06016, Exp 9/18;

D06024, D06025, D06026,

D06027, Exp 10/2018; c)

D06011, D06012,

D06013, Exp 9/18;

D06020, D06021, D06022,

D06023, Exp

Failed stability specifications - An out of specification result

was observed for the test parameter : composition of

Nystatin during stability testing

Dr. Reddy's

Laboratories, Inc.



Product Type

Product Description

Classification


Firm

10/2018

Drugs

Actoplus met XR (pioglitazone and metformin HCl,

extended-release) tablets, 15

mg/1000 mg, Rx Only, 30 tablet

bottle, Distributed by: Takeda

Pharmaceuticals America, Inc, Deerfield, IL 60015. NDC:

64764-510-30

Class II

Lot, expiry: A26004, exp

Apr 2020; A26443 and A26444, exp

Sep 2020

Defective Delivery System: tablets may be missing, in whole or in part, the laser

drilled holes on the metformin core of the Actoplus met XR

tablets.

Takeda Develop

ment Center

Americas, Inc.

Drugs

Glipizide XL (glipizide)

extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ

07977 --- NDC 59762-0541-2

Class II Lot: T71137

Exp. Feb. 2022

CGMP Deviations; rejected product was used to

manufacture final bulk lot Pfizer Inc.

Drugs

Magnesium Sulfate in Water

for Injection (0.325 mEq

Mg++/mL) 40 mg/mL, 20 g Total,

500 mL Single-Dose Container

bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-

6729-03.

Class II

Lot: 87904FW,

Exp. 1MAR2020

Correct Labeled Product Mispack: confirmed report

involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for

Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium

Sulfate in Water for Injection.

Pfizer Inc.



Product Type

Product Description

Classification


Firm

Drugs

THYROID POWDER USP, Full

Strength (Levothyroxine

labeled range of 103-

125mcg/grain; Liothyroine

(correct spelling Liothyronine):

labeled range of 24.3-

29.7mcg/grain) active

pharmaceutical ingredient; 5 KG

bag, Rx Compounding only, Manu By:

Sichuan Friendly Pharmaceutical

Co., Ltd., No. 680 Hongpai Road,

Neijiang, sichuan 641000, china;

Distributed: Syntec Pharma Corp., 96 Gazza

Blvd., FarmingdaleNY 11735, CAS No.

50809-32-0

Class II All lots

CGMP Deviations: Recall notice received from supplier that

Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and

liothyronine.

Syntec Pharma

Corp

Drugs

THYROID POWDER USP

(Levothyroxine labeled range of

34.2-41.8mcg/grain;

Liothyroine (correct spelling Liothyronine):

labeled range of 8.1-9.9mcg/grain)

active pharmaceutical

Class II All lots



liothyronine.

Syntec Pharma

Corp



Product Type

Product Description

Classification


Firm

ingredient; 25 KG bag, Rx

Compounding only, Manu By:

Sichuan Friendly Pharmaceutical

Co., Ltd., No. 680 Hongpai Road,

Neijiang, sichuan 641000, china;

Distributed: Syntec Pharma Corp., 96 Gazza

Blvd., Farmingdale NY 11735, CAS No.

50809-32-0

Drugs

Thyroid powder, 4.5 kg foil bag, 5x1

kg foil bags packed in 25 Kg

Fiber Drum, Thyroid Powder 25kg/drum, US

Pharmacopoeia, Sichuan Friendly Pharmaceutical

Co., LTD, Production

Address: No. 680, Hongpai Road,

Dongxing District, Neijiang City

Sichuan, China Tel:+886 832

2240082/2240298, NDC 7807-0170-

11

Class II Lot #

170501



liothyronine.

Alkano Chemical

s, Inc

Drugs

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx

only, Manufactured by: Jubilant Generics

Class II

Lot #: PA26038A, Exp 04/19; PA26039A, PA26040A, PA26050A, Exp 05/19; PA26052A,

Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.

Jubilant Cadista

Pharmaceuticals,

Inc.



Product Type

Product Description

Classification


Firm

Ltd., Roorkee - 247661, India; Marketed by:

Jubilant Cadista Pharmaceuticals

Inc., Salisbury, MD 21801; NDC

59746-284-90.

Exp 06/19; PA26073A, Exp 07/19;

PA217071A, PA217072A, PA217073B, PA217074B, Exp 06/20;

PA217101A, Exp 08/20;

and PA218023A, Exp 01/21.

Drugs

Morphine Sulfate Extended-Release

Tablets, 30 mg, 100-count bottle,

Rx only, Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873,

Manufactured for: Lupin

Pharmaceuticals, Inc. Baltimore,

MD 21202, NDC 43386-541-01

Class III Lot#

S800232, Exp 2/20

Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release

Tablets are being recalled due to out of Specification Result

noticed for Morphinone Sulfate impurity during 3 month

stability analysis and during retain testing.

LUPIN SOMERSE

T

Drugs

MethylPREDNISolone Tablets, USP,

4 mg, 21-count blister pack. Rx Only. Jubilant

Cadista Pharmaceuticals

Inc. Salisbury, MD NDC 59746-001-

03

Class III

Lot # 17P0078, exp. date 12/2018

Failed Stability Specifications: An out-of-specification result

was obtained during 18-month stability testing for assay

Jubilant Cadista

Pharmaceuticals,

Inc.

Drugs

Bupropion Hydrochloride ER Tablets, USP 150

mg, packaged in a) 90-count bottle

(NDC 69097-875-

Class III

Lot #: a) 1612130, 1612131,

Exp 11/18; 1709986, Exp 8/19;

Failed impurities/ degradation specifications: Out-of-

specification results were observed in the meta-

chlorobenzoic acid impurity in batches 18 months or older

InvaGen Pharmaceuticals,

Inc.



Product Type

Product Description

Classification


Firm

05), Manufactured for:

Cipla USA Inc., 1560 Sawgrass

Corporate Parkway, Suite 130 Sunrise, FL

33323 b) 90-count bottle (NDC

68001-322-05), For BluePoint

Laboratories, Rx only,

Manufactured by: InvaGen

Pharmaceuticals, Inc. (a subsidiary

of Cipla Ltd.) Hauppauge,

NY11788

1711549, Exp 10/19;

b) 1701171, 1701174, 1701175, 1701176,

Exp 12/18; 1705131, 1705132, 1705133, Exp 4/19; 1709986, 1709985, Exp 8/19;

17110257, Exp 9/19; 1712809, 1801041, 1801051,

Exp 12/19; 1802283, Exp 1/20

from date of manufacture in the 90 count bottle size.

Drugs

Levofloxacin Injection in 5%

Dextrose, 500 mg (5 mg/mL), 100

mL Container bag, Rx only,

Manufactured for: Claris Lifesciences

Inc., North Brunswick, NJ

08902; By: Claris Injectables Ltd., Gujarat, India,

NDC 36000-047-24.

Class III

Lot #: A0A0741, A0A0747, A0A0748,

Exp. 6/2019; A0A0814, A0A0815, A0A0823,

Exp. 7/2019; A0A0889, A0A0893,

Exp. 8/2019; A0A1005, A0A1006, A0A1008, A0A1012, A0A1016, A0A1028, A0A1036,

Exp. 10/2019

Superpotent Drug: High out of specification results for levofloxacin resulting in

increased concentration of solution.

Baxter Healthcar

e Corporati

on



Product Type

Product Description

Classification


Firm

Drugs

Levofloxacin Injection in 5%

Dextrose, 750 mg (5 mg/mL), 150

mL Container bag, Rx only,

Manufactured for: Claris Lifesciences

Inc., North Brunswick, NJ

08902; By: Claris Injectables Ltd., Gujarat, India,

NDC 36000-048-24.

Class III Lot #:

A0A0258, Exp 2/2019

Superpotent Drug: High out of specification results for levofloxacin resulting in

increased concentration of solution.

Baxter Healthcar

e Corporati

on

Drugs

Fenofibrate Tablets, USP 145

mg, 90-count bottles, Rx only,

Manufactured for: Camber

Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90

Class III Lot #:

E181370, Exp. 5/2020

Presence of Foreign Tablet/Capsule: A foreign

identified as Valacyclovir tablet 500 mg was co-mingled in a

bottle containing Fenofibrate Tablets, USP 145 mg.

Hetero Labs, Ltd. - Unit III Plot 22-

110, Part Ii, Ida

Drugs

treatNOW ABILIFY (aripiprazole) and

ABILIFY MAINTENA

(aripiprazole) 400MG for

extended release injectable

suspension. Kit Contents: 2 packs

ABILIFY Tablets 10mg (14 day supply) plus 1

ABILIFY MAINTENA Pre-

filled Dual Chamber Syringe Kit. Rx only. Not

for sale or reimbursement.

Class III

Lots: 7F92YUD3H1A/AIS1017

B, 7F92YUD3H1A/AIS1017C, EXP 30-Jun-2020.

Labeling Not Elsewhere Classified: Physician sample

kits/cartons of treatNOW Abilify are mislabeled. Product

name is misspelled, storage instructions are missing and

contents of kits may be incorrectly labeled on the outer packaging of the co-packaged

kit.

Otsuka Pharmaceutical

Development &

Commercialization,

Inc.



Product Type

Product Description

Classification


Firm

Distributed and Marketed by:

Otsuka America Pharmaceutical,

Inc. Rockville, MD 20850.Marketed by: Deerfield, IL 60015 USA. Bar

Code DCSKit-59148-10Tabs-01

Drugs

treatNOW ABILIFY (aripiprazole) /

ABILIFY MAINTENA 400-mg (aripiprazole)

for extended release injectable

suspension. Kit contents 2 packs Abilify Tablets 10

mg (14 day supply) plus 1

Abilfy Maintena Vial Kit.Rx only. Distributed and Marketed by:

Otsuka America Pharmaceutical,

Inc. Rockville, MD 20850 USA

Marketed by: Lundbleck,

Deerfield, IL 60015 USABar Code VialKit-

59148-10Tabs-02

Class III

Lots: 7F92YUD3H1A/ACS1616

B, EXP 31-Jul-2019;

F92YUD3H1A/ACS0118C

, EXP 30-Jun-2020.

Labeling Not Elsewhere Classified: Physician sample

kits/cartons of treatNOW Abilify are mislabeled. Product

name is misspelled, storage instructions are missing and

contents of kits may be incorrectly labeled on the outer packaging of the co-packaged

kit.

Otsuka Pharmaceutical

Development &

Commercialization,

Inc.

Drugs

Altavera Levonorgestrel

and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only,

3 tablet dispensers x 28

tablets.

Class III

Lots: LF11838A

Expiry May 2020;

LF12107A, LF12106A, Expiry June

2020

Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the

packaging component that may cause confusion.

Xiromed LLC



Product Type

Product Description

Classification


Firm

Manufactured by Laboratories Leon Farma S.A., Spain, for Xiromed, LLC., Florham Park, NJ 07932. Product of Spain NDC 70700-116-85 (I unit x 28

tablets 70700-116-84)

Drugs

Amlodipine Besylate USP 10

mg Tablets, 1000-count bottles, Rx

Only, Manufactured by: Cipla Ltd., Verna

Goa, India, Manufactured for:

Cipla USA, Inc. 1560 Sawgrass

Corporate Parkway, Suite 130, Sunrise FL

33323 UPC 369097128159, NDC 69097-128-

15

Class III

Lot #: GG80218,

Exp. 12/2019

Subpotent Drug: One lot of product does not meet the

product specification for Assay test at 3 month long term

stability condition.

InvaGen Pharmaceuticals,

Inc.

*Please refer to FDA website for further information at: http://www.fda.gov/Safety/Recalls/default.htm



CURRENT DRUG SHORTAGES

Ceftazidime Injection October 18, 2018 Reason for the Shortage

Pfizer has Tazicef available.

Sagent had ceftazidime injection on shortage due to manufacturing delays.

Sandoz discontinued ceftazidime 1 gram and 2 gram vials in 2015. Sandoz discontinued the 6 gram vials in early 2016.

BBraun had ceftazidime on allocation due to increased demand.

Teligent discontinued Fortaz 2 gram vials, 6 gram vials, and both 1 gram/50 mL and 2 gram/50 mL premixes in February 2018.

WG Critical Care has ceftazidime available. Estimated Resupply Dates

BBraun has ceftazidime 1 gram/50 mL and 2 gram/50 mL premixed bags on allocation.

Teligent has Fortaz 500 mg vials, 1 gram TwistVials, and 2 gram TwistVials on long-term back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=63 Daptomycin Injection October 18, 2018 Reason for the Shortage

Fresenius Kabi has daptomycin available.

Mylan Institutional has daptomycin available.

Pfizer has daptomycin on shortage due to manufacturing delays.

Teva has daptomycin on shortage due to increased demand.

Merck has Cubicin and Cubicin RF available. Estimated Resupply Dates

Fresenius Kabi has daptomycin 500 mg vials (NDC 63323-0371-10) on back order and the company estimates a release date of late-October 2018.

Pfizer has daptomycin 500 mg vials on back order and the company cannot estimate a release date.

Teva has daptomycin 500 mg vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=467 Diltiazem Hydrochloride Injection October 18, 2018 Reason for the Shortage

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.

Estimated Resupply Dates

Akorn has diltiazem 5 mg/mL 5 mL, 10 mL, and 25 mL vials on back order and the company cannot estimate a release date.

Hikma has diltiazem 5 mg/mL 5 mL, 10 mL, and 25 mL vials allocation.

Pfizer has 100 mg ADD-Vantage vials on back order and the company estimates a release date of November 2018. The 5 mg/mL 5 mL and 10 mL vials are also on back order and the company estimates a release date of 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=26 Furosemide Injection October 18, 2018 Reason for the Shortage

American Regent is not actively marketing furosemide injection.

Amneal did not provide a reason for the shortage.

Baxter (formerly Claris) did not provide a reason for the shortage.

Fresenius Kabi did not provide a reason for the shortage.

Heritage has furosemide injection available.

Pfizer has furosemide injection on shortage due to manufacturing delays and increased demand. Estimated Resupply Dates

Amneal has furosemide 10 mg/mL 2 mL vials on back order and the company cannot estimate a release date.

Pfizer has furosemide 10 mg/mL 4 mL vials, 10 mL vials, and 10 mL syringes available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=323 Indomethacin Capsules October 18, 2018 Reason for the Shortage

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. Estimated Resupply Dates

Camber has indomethacin 25 mg capsules in 100 count on allocation. The 50 mg capsules in 100 count are on back order and the company estimates a release date of late-October 2018.

Glenmark has indomethacin 50 mg capsules in 100 count and 500 count capsules on back order and the company estimates a release date of November 2018 for the 100 count size and early-



November 2018 for the 500 count size. The 25 mg capsules in 100 count and 1000 count are on back order and the company estimates a release date of late-October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=235 Leucovorin Calcium Injection October 18, 2018 Reason for the Shortage

Fresenius Kabi has leucovorin on shortage due to manufacturing delays and increased demand.

Hikma did not provide a reason for the current shortage.

Sagent had leucovorin on shortage due to increased demand.

Teva has leucovorin available. Estimated Resupply Dates

Fresenius Kabi has leucovorin 200 mg and 500 mg vials on back order and the company estimates a release date of late-October to early-November 2018 for the 200 mg vials and mid-November 2018 for the 500 mg vials.

Hikma has leucovorin 100 mg vials on back order and the company estimates a release date of November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=35 Magnesium Sulfate Injection October 18, 2018 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 has magnesium sulfate injection on shortage due to increased demand for the product.


Fresenius Kabi has magnesium sulfate 500 mg/mL 2 mL, 10 mL, 20 mL and 50 mL vials on back order and the company estimates a release date of mid-October 2018 for the 2 mL vials, early-November 2018 for the 10 mL vials, and late-October to early-November 2018 for the 20 mL vials and 50 mL vials. The 40 mg/mL 50 mL, 100 mL, and 500mL premixed bags are on back order and the company estimates a release date of mid-October 2018 for the 50 mL and 100 mL premixed bags and late-November 2018 for the 500 mL premixed bags. The 80 mg/mL 50 mL premixed bags are on back order and the company estimates a release date of late-November 2018.

Pfizer has magnesium sulfate 500 mg/mL 20 mL vials on back order and the company estimates a release date of 2019. The 500 mg/mL 10 mL syringes are on back order and the company estimates a release date of November 2018. The magnesium sulfate 10 mg/mL 100 mL bags are



on back order and the company estimates a release date of November 2018. The magnesium sulfate 40 mg/mL 50 mL, 100 mL, 500 mL, and 1000 mL bags are on back order and the company estimates a release date of October 2018 for the 1000 mL bags, November 2018 for the 50 mL bags and 500 mL bags, and December 2018 for the 100 mL bags. The 80 mg/mL 50 mL bags are on back order and the company estimates a release date of December 2018.

WG Critical Care has magnesium sulfate 40 mg/mL 50 mL premixed bags on back order and the company estimates a release date of late-October 2018. Check wholesalers for inventory.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=21 Pamidronate Disodium Injection October 18, 2018 Reason for the Shortage

Areva has pamidronate powder for injection available.

Mylan Institutional did not provide a reason for the shortage.

Pfizer has pamidronate on shortage due to manufacturing delays. Estimated Resupply Dates

Pfizer has pamidronate 9 mg/mL 10 mL vials available in limited supply. The 6 mg/mL 10 mL vials are on back order and the company estimates a release date of November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=402 Tobramycin Sulfate Injection October 18, 2018 Reason for the Shortage

Akorn has tobramycin injection on shortage due to manufacturing delays.

Pfizer has tobramycin injection on shortage due to manufacturing delays.

Teva discontinued tobramycin 40 mg/mL 30 mL vials in June 2018. Estimated Resupply Dates

Akorn has tobramycin 40 mg/mL 2 mL and 30 mL vials on back order and the company cannot estimate a release date.

Baxter (formerly Claris) has tobramycin 40 mg/mL 2 mL and 30 mL vials on back order and the company cannot estimate a release date.

Fresenius Kabi has tobramycin 40 mg/mL 2 mL vials on back order and the company estimates a release date of mid-November 2018. The 10 mg/mL 2 mL vials are on back order and the company estimates a release date of late-November 2018. The tobramycin 1.2 gram preservative-free 50 mL vials are on back order and the company estimates a release date of early-November 2018. There are short-dated 40 mg/mL 30 mL vials with an expiration date of <3 months.

Mylan Institutional has tobramycin 40 mg/mL 2 mL vials on back order and the company cannot estimate a release date.

Pfizer has tobramycin 40 mg/mL 2 mL vials on back order and the company estimates a release date of November 2018.

Teva has temporarily discontinued tobramycin 40 mg/mL 2 mL vials. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=164



Piperacillin and Tazobactam Injection October 17, 2018 Reason for the Shortage

Apotex temporarily discontinued piperacillin/tazobactam in April 2018.

AuroMedics could not provide a reason for the shortage.

Fresenius Kabi had piperacillin/tazobactam on shortage due to increased demand.

Mylan Institutional launched piperacillin/tazobactam 3.375 gram and 4.5 gram vials in early-June 2016.

Pfizer has Zosyn single dose vials and piperacillin/tazobactam on shortage due to manufacturing delays.

Sagent had piperacillin/tazobactam on shortage due to increased demand.

WG Critical Care states the reason for the shortage is increased demand.

FDA in conjunction with SteriMax was allowing temporary importation of piperacillin/tazobactam 3.375 gram, 4.5 gram, and 40.5 gram vials from Canada. This was being distributed through X-Gen Pharmaceuticals. These are no longer being imported with the launch of the products from X-Gen. The product codes on these items will not be recognized by U.S. systems so institutions will need to implement alternative plans to assure the dose is being given correctly. More information can be found on the FDA site at: https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM543149.pdf.

Wockhardt has piperacillin/tazobactam injection available.

X-Gen has piperacillin/tazobactam injection available. Estimated Resupply Dates

Apotex has temporarily discontinued all piperacillin/tazobactam presentations.

Baxter has Zosyn frozen premixed bags on allocation with intermittent delivery of product.

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 2019.

Mylan has piperacillin/tazobactam 3.375 gram vials on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=158 Acetylcysteine Oral and Inhalation Solution October 16, 2018 Reason for the Shortage

American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays. They are not currently marketing the 10 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. Estimated Resupply Dates

American Regent has acetylcysteine solution 200 mg/mL 30 mL vials on back order and the company cannot estimate a release date.



Fresenius Kabi has short-dated acetylcysteine solution 100 mg/mL 4 mL vials available with an expiration date of <9 months.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=43 Buprenorphine Hydrochloride Injection October 16, 2018 Reason for the Shortage

Pfizer has buprenorphine injection on shortage due to manufacturing delays.

Par had buprenorphine injection on shortage due to increased demand. Estimated Resupply Dates

Pfizer has buprenorphine 0.3 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date of 2nd quarter 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=419 Cefotaxime Sodium Injection October 16, 2018 Reason for the Shortage

Hospira has discontinued Claforan. Sanofi-Aventis manufactured Claforan for Hospira and is no longer making the product.

Baxter discontinued Claforan in late-2015.

Hikma is not currently marketing cefotaxime injection. Estimated Resupply Dates

There are no marketed presentations available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=51 Dexrazoxane Injection October 16, 2018 Reason for the Shortage

Cumberland Pharmaceuticals relaunched Totect in late-July 2017.

Hikma did not provide a reason for the shortage.

Mylan Institutional has dexrazoxane available.

Pfizer states manufacturing delay as the reason for the shortage. Estimated Resupply Dates

Hikma has dexrazoxane 250 mg and 500 mg vials on back order and the company estimates a release date of late-October to early-November 2018.

Pfizer has Zinecard 250 mg vials available in limited supply. The 500 mg vials are on back order and the company estimates a release date of 1st quarter 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=107



Epinephrine Auto-Injectors October 16, 2018 Reason for the Shortage

Impax was not able to provide a reason for the shortage.

Mylan has EpiPen on shortage due to supply constraints Estimated Resupply Dates

Impax has epinephrine 0.15 mg/0.15 mL and 0.3 mg/0.3 mL auto-injectors on back order and the company cannot estimate a release date.

Mylan has Epipen, EpiPen Jr, and their authorized generic presentations on intermittent back order with regular releases.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=420 Hydromorphone Hydrochloride Injection October 16, 2018 Reason for the Shortage

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]

Hikma did not provide a reason for the shortage.[6] Estimated Resupply Dates

Akorn has hydromorphone 10 mg/mL 1 mL ampules, 5 mL ampules, and 50 mL vials on intermittent back order and the company is allocating product upon release.[1]

Fresenius Kabi has Dilaudid 1 mg/mL 0.5 mL syringes on back order and the company estimates a release date of mid-October 2018. The 1 mg/mL 1 mL syringes are on back order and the company estimates a release date of mid-October 2018. The 2 mg/mL 1 mL syringes are on back order and the company estimates a release date of 1st quarter 2019. The hydromorphone 1 mg/mL 1 mL vials are on back order and the company estimates a release date of early-November 2018. The hydromorphone 4 mg/mL 1 mL vials are on back order and the company estimates a release date of late-December 2018. The hydromorphone 10 mg/mL 1 mL vials and 5 mL vials are on back order and the company cannot estimate a release date.[2]

Hikma has hydromorphone 2 mg/mL 20 mL vials on back order and the company estimates a release date of mid-October 2018.[6]

Pfizer has 2 mg/mL 1 mL vials on back order and the company estimates a release date of October 2018. The 10 mg/mL 1 mL and 5 mL vials are on back order and the company estimates a release date of early-November 2018. The 1 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of 1st quarter 2019. The 10 mg/mL 50 mL vials and 0.5 mg/0.5 mL 0.5 mL iSecure syringes are on back order and the company estimates a release date of 1st quarter 2019. The 2 mg/mL 1 mL Carpuject syringes, 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 cannot estimate a release date. The 1 mg/mL 1 mL iSecure syringes and 2 mg/mL 1 mL iSecure syringes



are on back order and the company estimates a release date of 2nd quarter 2019. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of 4th quarter 2019.[3]

Teva has hydromorphone 10 mg/mL 5 mL and 50 mL vials on intermittent back order and the company is allocating product upon release.[5]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=329 Lidocaine Injection October 16, 2018 Reason for the Shortage

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. Estimated Resupply Dates

AuroMedics has 1% lidocaine 2 mL and 5 mL ampules and 2 mL, 5 mL, and 30 mL vials on intermittent back order and the company is releasing product as it becomes available. AuroMedics has 2% lidocaine 2 mL ampules and 2 mL and 5 mL vials on intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has 0.5% Xylocaine 50 mL vials on back order and the company cannot estimate a release date. The 0.5% Xylocaine 50 mL MPF vials are on back order and the company estimates a release date of mid-October 2018. The 1% lidocaine 2 mL and 10 mL vials are on back order and the company estimates a release date of late-October 2018 for the 2 mL vials and early-December 2018 for the 10 mL vials. The 1% Xylocaine 20 mL and 50 mL vials are on back order and the company estimates a release date of mid-October 2018 for the 20 mL vials and late-October to early-November 2018 for the 50 mL vials. The 1% Xylocaine-MPF 2 mL, 5 mL, and 30 mL vials are on back order and the company estimates a release date of mid-October 2018 for the 2 mL and 5 mL vials and mid-December 2018 for the 30 mL vials. The 1% Xylocaine-MPF 10 mL ampule sterile packs are on back order and the company estimates a release date of late-December 2018. 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 20 mL ampules are on back order and the company estimates a release date of late-December 2018. The 2% Xylocaine 10 mL, 20 mL, and 50 mL vials are on back order and the company estimates a release date of late-October 2018 for the 10 mL and 50 mL vials and mid-November 2018 for the 20 mL vials. The 2% Xylocaine-MPF 2 mL vials are on back order and the company estimates a release date of late-October to early-November 2018. The 2% Xylocaine-MPF 10 mL ampules are on back order and the company estimates a release date of late-December 2018. The 2% lidocaine 2 mL and 5 mL vials are on back order and the company estimates a release date of early-November 2018. Check wholesalers for inventory.

Pfizer has 0.5% lidocaine 50 mL tear top vials on back order and the company estimates a release date of December 2018. The 0.5% lidocaine flip top vials are on back order and the company estimates a release date of 1st quarter 2019. The 1% lidocaine 2 mL preservative-free ampules on back order and the company estimates a release date of November 2018. The 1%



lidocaine 5 mL preservative-free ampules are on back order and the company estimates a release date of 1st quarter 2020. The 1% lidocaine 20 mL vials and 30 mL preservative-free vials are on back order and the company estimates a release date of November 2018. The 1% lidocaine 50 mL vials are on back order and the company estimates a release date of November 2018. The 1% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of December 2018. The 1% lidocaine 5 mL Ansyr syringes are on back order and the company estimates a release date of November 2018. The 2% lidocaine 10 mL ampules are on back order and the company cannot estimate a release date. The 2% lidocaine 5 mL vials are on back order and the company estimates a release date of 3rd quarter 2019. The 2% lidocaine 20 mL and 50 mL vials are on back order and the company estimates a release date of October 2018. The 2% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of December 2018. The 2% lidocaine 5 mL Ansyr syringes are on back order and the company estimates a release date of October 2018. The 4% lidocaine 5 mL ampules are on back order and the company estimates a release date of December 2018.

Hikma has 1% lidocaine 5 mL preservative-free vials on back order and the company estimates a release date of mid-October 2018. The 1% lidocaine 50 mL vials are on back order and the company estimates a release date of late-October to early-November 2018. The 2% lidocaine 5 mL preservative-free vials are on back order and the company estimates a release date of mid-October 2018. The 2% lidocaine 50 mL vials are on back order and the company estimates a release date of late-October to early-November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=88 Morphine Injection October 16, 2018 Reason for the Shortage

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 states the shortage is due to manufacturing delays. Pfizer discontinued morphine ADD-Vantage vials in January 2017.[3]

Pfizer anticipates 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. Pfizer expects the shortage of prefilled syringe products to recover by late-first quarter 2018.[3]

Hikma did not provide a reason for the shortage. West-Ward is not actively marketing the 15 mg/mL 1 mL vials or the 8 mg/mL 1 mL vials (NDC 00641-6075-25). They are still marketing the 8 mg/mL 1 mL vials with NDC 00641-6126-25.[4]


Fresenius Kabi has morphine 2 mg/mL 1 mL syringes on back order and the company estimates a release date of mid-October 2018. The morphine 4 mg/mL 1 mL syringes are on back order and the company estimates a release date of 1st quarter 2019. The morphine 5 mg/mL 1 mL syringes are on back order and the company cannot estimate a release date. The 2 mg/mL 1 mL vials are on back order and the company estimates a release date of late-November 2018. The 4 mg/mL 1 mL vials are on back order and the company estimates a release date of late-October 2018.



The 5 mg/mL 1 mL vials are on back order and the company estimates a release date of early-December 2018. The 8 mg/mL 1 mL vials are on back order and the company cannot estimate a release date. The 10 mg/mL 1 mL vials are on back order and the company estimates a release date of mid- to late-November 2018. Check wholesalers for inventory.[2]

Pfizer has morphine 2 mg/mL 1 mL Carpuject syringes and 4 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date of 1st quarter 2019. The 2 mg/mL 1 mL iSecure syringes, 4 mg/mL 1 mL iSecure syringes, 8 mg/mL 1 mL Carpuject syringes, 8 mg/mL 1 mL iSecure syringes, 10 mg/mL 1 mL iSecure syringes, and 10 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of 2nd quarter 2019. The 50 mg/mL 50 mL vials are on back order and the company estimates a release date of October 2018.[3]

Hikma has morphine 4 mg/mL, 8 mg/mL, and 10 mg/mL 1 mL vials on allocation. Infumorph 10 mg/mL 20 mL ampules and 25 mg/mL 20 mL ampules are on back order and the company estimates a release date of November to December 2018. Duramorph 1 mg/mL 10 mL ampules are on allocation. Duramorph 0.5 mg/mL 10 mL ampules are on allocation.[4]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=41 Trifluoperazine Tablets October 16, 2018 Reason for the Shortage

Mylan did not provide a reason for the shortage.

Upsher-Smith did not provide a reason for the shortage. Estimated Resupply Dates

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 late-December 2018 for the 1 mg tablets, early-November 2018 for the 2 mg and 5 mg tablets, and mid-November 2018 for the 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-January 2019 for the 1 mg tablets and mid- to late-December 2018 for the 2 mg, 5 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.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=457 23.4% Sodium Chloride Injection October 15, 2018 Reason for the Shortage

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. Estimated Resupply Dates

Fresenius Kabi has 23.4% sodium chloride 30 mL, 100 mL, and 200 mL vials on back order and the company estimates a release date of early-December 2018 for the 30 mL vials, late-October 2018 for the 100 mL vials, and mid-December 2018 for the 200 mL vials. Check wholesalers for inventory.



Pfizer has 23.4% sodium chloride 200 mL vials on back order and the company estimates a release date of 3rd quarter 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=336 Bumetanide Injection October 15, 2018 Reason for the Shortage

Pfizer has bumetanide injection on shortage due to manufacturing delays.

Hikma did not provide a reason for the shortage. Estimated Resupply Dates

Pfizer has bumetanide 0.25 mg/mL 4 mL and 10 mL vials on back order and the company estimates a release date of 2nd quarter 2019 for the 4 mL vials and 2019 for the 10 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=307 Bupivacaine Injection October 15, 2018 Reason for the Shortage

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 mid-October 2018. The 0.25% 30 mL preservative-free vials are on back order and the company estimates a release date of late-October 2018. The 0.25% 50 mL vials are on back order and the company estimates a release date of mid-November 2018. The 0.5% Sensorcaine 10 mL preservative-free vials are on back order and the company estimates release dates of mid-October 2018. The 0.5% Sensorcaine 30 mL preservative-free vials are on back order and the company estimates release dates of early-December 2018. The 0.5% Sensorcaine 50 mL vials are on back order and the company estimates a release date of mid-October 2018. The 0.75% 30 mL preservative-free vials are on back order and the company cannot estimate a release date. 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 November 2018 for the 10 mL vials and December 2018 for the 30 mL vials. The 0.25% bupivacaine 50 mL vials are on back order and the company estimates release dates of October 2018. The 0.5% bupivacaine 10 mL and 30 mL preservative-



free vials are on back order and the company estimates a release date of December 2018 for the 10 mL vials and November 2018 for the 30 mL vials. The 0.5% bupivacaine 50 mL vials are on back order and the company estimates a release date of December 2018. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of 1st quarter 2019 for the 10 mL vials and November 2018 for the 30 mL vials. The bupivacaine 0.75% in 8.25% dextrose 2 mL ampules are available in limited supply.

Pfizer has all Marcaine presentations on back order and the company estimates a release date of 1st quarter 2020 except for the Marcaine 0.75% in 8.25% dextrose 2 mL ampules are on back order and the company estimates a release date of October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=172 Bupivacaine with Epinephrine Injection October 15, 2018 Reason for the Shortage

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. Estimated Resupply Dates

Fresenius Kabi has 0.25% Sensorcaine-MPF with epinephrine 10 mL vials on back order and the company estimates a release date of mid-October 2018. The 0.25% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of mid-October 2018. The 0.25% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of late-October 2018. The 0.5% Sensorcaine-MPF with epinephrine 10 mL vials are on back order and the company estimates a release date of mid-October 2018. The 0.5% Sensorcaine-MPF with epinephrine 30 mL sterile packs are on back order and the company cannot estimate a release date. The 0.5% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of late-October 2018.

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 3rd quarter 2019. The 0.25% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of 3rd quarter 2019. The 0.5% bupivacaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of 3rd quarter 2019. The 0.5% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of October 2018. The 0.5% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of 3rd quarter 2019.

Pfizer has 0.25% Marcaine with epinephrine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of 3rd quarter 2019. The 0.25% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of 3rd quarter 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 1st quarter 2020. The 0.5% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of 3rd quarter 2019.




Chlorothiazide Sodium Injection October 15, 2018 Reason for the Shortage

Akorn had chlorothiazide injection on shortage due to manufacturing delays.

Sagent had chlorothiazide injection on shortage due to increased demand.

Sun Pharma has chlorothiazide injection available. Estimated Resupply Dates

Fresenius Kabi has chlorothiazide 500 mg vials on back order and the company estimates a release date of late-October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=365 Fluorescein Sodium Ophthalmic Strips October 15, 2018 Reason for the Shortage

Hub has Bio-Glo on shortage because demand exceeds supply.

Akorn did not provide a reason for the shortage. Estimated Resupply Dates

Akorn has Ful-Glo 0.6 mg strips on back order and the company estimates a release date of 2nd quarter 2019. The 1 mg strips are on back order and the company estimates a release date of November 2018.

Hub has Bio-Glo 1 mg strips on intermittent back order and the company is releasing supplies as they become available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=362 Haloperidol Tablets October 15, 2018 Reason for the Shortage


Sandoz has discontinued haloperidol 0.5 mg and 1 mg tablets. Estimated Resupply Dates

Mylan has haloperidol 0.5 mg, 1 mg, 2 mg, 5 mg, and 10 mg tablets in 100 count unit-dose packs on back order and the company estimates a release date of late-February to early-March 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, 5 mg tablets in 100 count and 1000 count, 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-March 2019.




Lidocaine with Epinephrine Injection October 15, 2018 Reason for the Shortage

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. Estimated Resupply Dates

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 mid-October 2018. The 1% Xylocaine with epinephrine (1:200,000) 10 mL vials are on back order and the company estimates a release date of mid-October 2018. The 1% Xylocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates release dates of late-October 2018. The 1% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the company estimates release dates of late-October 2018. The 1% Xylocaine-MPF with epinephrine (1:200,000) 10 mL vials are on back order and the company estimates a release date of mid- to late-November 2018. 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 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) 10 mL regular vials are on back order and the company estimates a release date of mid-November 2018. The 2% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the company estimates a release date of late-October to early-November 2018. The 2% Xylocaine-MPF with epinephrine (1:200,000) 10 mL vials are on back order and the company estimates a release date of early-November 2018. 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 0.5% lidocaine with epinephrine (1:200,000) 50 mL vials on back order and the company estimates a release date of December 2018. The 1% lidocaine with epinephrine (1:100,000) 20 mL vials are on back order and the company estimates a release date of October 2018. The 1% lidocaine with epinephrine (1:100,000) 30 mL vials are on back order and the company estimates a release date of December 2018. The 1% lidocaine with epinephrine (1:100,000) 50 mL vials are on back order and the company estimates a release date of October 2018.The 1.5% lidocaine with epinephrine (1:200,000) 30 mL vials are on back order and the company estimates a release date of 1st quarter 2019. The 1.5% lidocaine with epinephrine (1:200,000) 5 mL ampules are on back order and the company estimates a release date of 1st quarter 2019. The 2% lidocaine with epinephrine (1:100,000) 20 mL vials are on back order and the company estimates a release date of October 2018. 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 1st quarter 2019 for the 30 mL vials and 2nd quarter 2019 for the 50 mL vials. The 2% lidocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates a release date of 1st quarter 2019.




Orphenadrine Citrate Injection October 15, 2018 Reason for the Shortage

Akorn did not provide a reason for the shortage.


Akorn has orphenadrine 30 mg/mL 2 mL vials on back order and the company cannot estimate a release date.

Hikma has orphenadrine 30 mg/mL 2 mL vials on back order and the company estimates a release date of late-October to early-November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=471 Phenytoin Sodium Injection October 15, 2018 Reason for the Shortage

Hikma did not provide a reason for this shortage.

X-Gen Pharmaceuticals discontinued their phenytoin sodium presentations in April 2017. Estimated Resupply Dates

Hikma has phenytoin sodium 50 mg/mL 2 mL and 5 mL vials on back order and the company estimates a release date of mid-October 2018 for the 2 mL vials and mid- to late-October 2108 for the 5 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=406 Potassium Phosphate Injection October 15, 2018 Reason for the Shortage

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 has potassium phosphate injection on shortage due to manufacturing delays. Estimated Resupply Dates

Pfizer has potassium phosphate 3 mmol/mL 15 mL vials on back order and the company estimates a release date of November 2018.

Fresenius Kabi has potassium phosphate 3 mmol/mL 5 mL and 50 mL vials on back order and the company estimates a release date of mid-November 2018 for the 5 mL vials and late-October 2018 for the 50 mL vials. The 15 mL vials are on back order and the company cannot estimate a release date.




Protamine Injection October 15, 2018 Reason for the Shortage

Fresenius Kabi had protamine on a short-term shortage due to increased demand. Estimated Resupply Dates

Fresenius Kabi has protamine 10 mg/mL 5 mL and 25 mL vials available. Check wholesalers for inventory.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=453 Pyridoxine Hydrochloride Injection October 15, 2018 Products Affected - Description

Pyridoxine injection, Fresenius Kabi, 100 mg/mL, 1 mL vial, 25 count, NDC 63323-0180-01 Reason for the Shortage

Fresenius Kabi had pyridoxine on shortage due to manufacturing delays. They are the sole suppliers of pyridoxine injection.


Fresenius Kabi has pyridoxine 100 mg/mL 1 mL vials on back order and the company estimates a release date of early-November 2018. Check wholesaler for inventory.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=450 Ropivacaine Injection October 15, 2018 Reason for the Shortage

Akorn has ropivacaine on shortage due to increased demand.

AuroMedics did not provide a reason for the shortage.

Fresenius Kabi has Naropin on shortage due to increased demand and manufacturing delays.

Pfizer had ropivacaine on shortage due to manufacturing delays. Estimated Resupply Dates

AuroMedics has ropivcaine 10 mg/mL 10 mL vials on intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has Naropin 2 mg/mL 100 mL premixed bags on back order and the company estimates a release date of mid-to late-November 2018. The 5 mg/mL 30 mL Steripak ampules are on back order and the company estimates a release date of mid- to late-November 2018. The 5 mg/mL 100 mL bottles are on back order and the company estimates a release date of early-November 2018. Check wholesalers for inventory.




Sterile Water for Injection – Small Volume Vials October 15, 2018 Reason for the Shortage

American Regent is not marketing sterile water for injection 20 mL vials at this time.

Fresenius Kabi has sterile water on shortage due to increased demand.

Pfizer has sterile water for injection in vials on shortage due to increased demand. Estimated Resupply Dates

Fresenius Kabi has sterile water for injection 50 mL vials on back order and the company estimates a release date of mid-November 2018. The 100 mL vials are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

Pfizer has sterile water for injection 20 mL, 50 mL, and 100 mL vials on back order and the company estimates a release date of October 2018 for the 20 mL and 50 mL vials and November 2018 for the 100 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=375 Thiothixene Capsules October 15, 2018 Reason for the Shortage


Mylan is the sole supplier of thiothixene. Estimated Resupply Dates

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-November 2018 for the 1 mg capsules, late-November 2018 for the 2 mg capsules, mid-December 2018 for the 5 mg capsules, and late-December 2018 for the 10 mg capsules.

Mylan Institutional has thiothixene 2 mg, 5mg, and 10 mg capsules in 100 count unit-dose blister packs on back order and the company estimates a release date of early-January 2019 for the 2 mg capsules, mid-January 2019 for the 5 mg capsules, and late-January to early-February 2019 for the 10 mg capsules.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=418 Atropine Sulfate Injection October 12, 2018 Reason for the Shortage

American Regent had atropine injection on shortage due to market demand.

Amphastar has atropine injection available.

Pfizer has atropine injection on shortage due to manufacturing delays.

Hikma has atropine injection available. Estimated Resupply Dates

Pfizer has atropine 0.1 mg/mL 10 mL LifeShield syringes on back order and the company estimates a release date of October 2018. The 0.1 mg/mL 10 mL Ansyr syringes are on back



order and the company estimates a release date of October 2018. The 0.1 mg/mL 5 mL LifeShield syringes are on back order and the company estimates release dates of December 2018. The 0.05 mg/mL 5 mL Ansyr syringes are available with an expiration date of February 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=46 Chloroprocaine Hydrochloride Injection October 12, 2018 Reason for the Shortage



Hikma has chloroprocaine hydrochloride 20 mg/mL 20 mL preservative-free vials and 30 mg/mL 20 mL preservative-free vials on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=455 Diazepam Injection October 12, 2018 Reason for the Shortage

Pfizer has diazepam on shortage due manufacturing delays. Estimated Resupply Dates

Pfizer has diazepam 5 mg/mL 2 mL Carpuject syringes on back order and the company estimates a release date of November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=330 Fentanyl Citrate Injection October 12, 2018 Reason for the Shortage

Akorn has fentanyl injection on shortage due to increased demand.

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.


Akorn has Sublimaze 50 mcg/mL 2 mL ampules in 10 count and 25 count, and 5 mL ampules in 10 count and 25 count on allocation.

Hikma has fentanyl 50 mcg/mL 2 mL, 5 mL, 20 mL, and 50 mL vials on allocation.

Pfizer has fentanyl 50 mcg/mL 2 mL ampules on back order and the company estimates a release date of October 2018. The 2 mL Carpuject syringes are on back order and the company estimates a release date of 3rd quarter 2019. The 2 mL vials are on back order and the company estimates a release date of October 2018. The 50 mL vials are available in limited supply.



https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=315 Heparin Sodium Premixed Bags October 12, 2018 Reason for the Shortage

Baxter has heparin on shortage due to manufacturing delays.

BBraun did not provide a reason for the shortage.

Fresenius Kabi has heparin premixes on shortage due to increased demand.

Pfizer has heparin on shortage due to manufacturing delays. Estimated Resupply Dates

Baxter has heparin 2000 units/1000 mL premixed bags on back order and the company cannot estimate a release date.

BBraun has all heparin premixed bags on allocation.

Fresenius Kabi has heparin 25,000 units/500 mL 0.45% sodium chloride premixed bags on back order and the company estimates a release date of mid-November 2018. The 25,000 units/250 mL 5% dextrose premixed bags are on back order and the company estimates a release date of mid-December 2018.

Pfizer has heparin 12,500 units/250 mL 0.45% sodium chloride and 2000 units/1000 mL 0.9% sodium chloride premixed bags on back order and the company estimates a release date of September 2018. The 25,000 units/250 mL 5% dextrose premixed bags and 1000 units/500 mL 0.9% sodium chloride,are on back order and the company estimates a release date of November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=468 Hydralazine Injection October 12, 2018 Reason for the Shortage

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. Estimated Resupply Dates

Akorn has hydralazine 20 mg/mL 1 mL vials on back order and the company cannot estimate a release date.

Fresenius Kabi has hydralazine 20 mg/mL 1 mL vials on back order and the company estimates a release date of mid-October 2018.

X-Gen has hydralazine 20 mg/mL 1 mL vials on back order and the company estimates a release date of mid-November 2018.




Iron Dextran Injection October 12, 2018 Reason for the Shortage

Allergan had INFeD on shortage due to manufacturing delays.

American Regent discontinued Dexferrum injection in 2014. Estimated Resupply Dates

Allergan has INFeD 50 mg/mL 2 mL vials on back order and the company estimates a release date of late-November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=408 Ketamine Injection October 12, 2018 Reason for the Shortage



Par has Ketalar on shortage due to increased demand.

Pfizer has ketamine on shortage due to manufacturing delays. Estimated Resupply Dates

Hikma has ketamine 50 mg/mL 10 mL vials and 100 mg/mL 5 mL vials on allocation.

Mylan Institutional has ketamine 10 mg/mL 20 mL on back order and the company cannot estimate a release date. The 50 mg/mL 10 mL vials are on back order and the company cannot estimate a release date. The 100 mg/mL 10 mL vials are on back order and the company estimates a release date of late-January 2019.

Pfizer has ketamine 50 mg/mL 10 mL vials on back order and the company estimates a release date of 1st quarter 2020. The 100 mg/mL 5 mL vials are on back order and the company estimates a release date of 3rd quarter 2019.

Par has Ketalar 10 mg/mL 20 mL vials, 50 mg/mL 10 mL vials, and 100 mg/mL 5 mL vials on intermittent back order with monthly releases.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=391 Meperidine Hydrochloride Injection October 12, 2018 Reason for the Shortage

Pfizer has Demerol injection on shortage due to manufacturing delays. Estimated Resupply Dates

Pfizer has Demerol 100 mg/mL 20 mL vials and on back order and the company estimates a release date of 3rd quarter 2019. 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 1st quarter 2020. 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 3rd quarter 2019. The 50 mg/mL 1 mL ampules are on back order and the company estimates a release date of mid-December 2018.



The 50 mg/mL 2 mL ampules are on back order and the company estimates a release date of 1st quarter 2019. The 50 mg/mL 30 mL vials are on back order and the company estimates a release date of 2019. The 50 mg/mL 1.5 mL ampules are on back order and the company estimates a release date of December 2018. The 100 mg/mL 1 mL ampules are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=347 Mepivacaine Injection October 12, 2018 Reasons for the Shortage

N/A Estimated Resupply Dates

Fresenius Kabi has 1.5% Polocaine-MPF 30 mL vials on back order and the company estimates a release date of mid-October 2018. The 2% Polocaine-MPF 20 mL vials are on back order and the company cannot estimate a release date. The 1% Polocaine 50 mL vials are on back order and the company estimates a release date of mid-October 2018. 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 1st quarter 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=331 Mycophenolate Mofetil Capsules and Tablets October 12, 2018 Reason for the Shortage

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. Estimated Resupply Dates

Accord has limited releases of their mycophenolate presentations.

Ascend has all mycophenolate mofetil presentations on intermittent back order and the company is releasing product as it becomes available.

Hikma has all mycophenolate mofetil presentations on allocation.

Mylan has mycophenolate mofetil 250 mg capsules in 100 count on back order and the company estimates a release date of mid-December 2018. The 500 mg tablets in 100 count and 500 count are on back order and the company estimates a release date of mid-November 2018. The 250 mg and 500 mg capsules in 100 count unit-dose presentations are on back order and the company estimates a release date of mid-October 2018 for the 250 mg capsules and early-December 2018 for the 500 mg capsules.

Sandoz has mycophenolate mofetil 250 mg capsules in 100 count and 500 count, and 500 mg tablets in 100 count and 500 count on back order and the company estimates a release date of late-October 2018.



https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=448 Procainamide Hydrochloride Injection October 12, 2018 Reason for the Shortage

Amphastar has procainamide injection available.

Nexus has procainamide injection available.

Pfizer has procainamide injection on shortage due to manufacturing delays. Estimated Resupply Dates

Pfizer has procainamide 100 mg/mL 10 mL vials on back order and the company estimates a release date of 1st quarter 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=469 Progesterone Injection October 12, 2018 Reason for the Shortage

American Regent is not currently marketing progesterone injection.

Fresenius Kabi has progesterone on shortage due to increased demand and manufacturing delays.


Fresenius Kabi has progesterone in oil 50 mg/mL 10 mL vials for intramuscular injection on back order and the company estimates a release date of late-November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=381 Promethazine Injection October 12, 2018 Reason for the Shortage


X-Gen has promethazine injection available. Estimated Resupply Dates

Hikma has promethazine 25 mg/mL 1 mL ampules on back order and the company estimates a release date of mid-October 2018. The 25 mg/mL 1 mL vials are on allocation. The 50 mg/mL 1 mL ampules are on back order and the company estimates a release date of mid-October 2018. The 50 mg/mL 1 mL vials are on back order and the company estimates a release date of mid- to late-October 2018.

Hikma has Phenergan 25 mg/mL 1 mL vials on allocation. The 25 mg/mL 1 mL ampules are on back order and the company cannot estimate a release date. There are short-dated 50 mg/mL 1 mL vials available with an expiration date of




Remifentanil Injection October 12, 2018 Reason for the Shortage


Fresnius Kabi launched generic remifentanil in January 2018. Estimated Resupply Dates

Mylan Institutional has Ultiva 1 mg, 2 mg, and 5 mg vials on back order and the company estimates a release date of mid-October 2018 for the 1 mg vials, late-October 2018 for the 2 mg vials, and mid-November 2018 for the 5 mg vials.

Fresenius Kabi has remifentanil 5 mg vials on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=371 Sodium Bicarbonate Injection October 12, 2018 Reason for the Shortage

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.[3]


Pfizer has sodium bicarbonate 4.2% 10 mL LifeShield syringes, 7.5% 50 mL syringes, and 8.4% 50 mL syringes available in limited supply. The 8.4% 10 mL syringes are on back order and the company estimates a release ate of October 2018. The 8.4% 50 mL vials are on back order and the company estimates a release date of November 2018.[2]

Pfizer has Neut 4% 5 mL vials on back order and the company estimates a release date of 1st quarter 2019.[2]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=293 Sodium Phosphate Injection October 12, 2018 Reason for the Shortage

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] Estimated Resupply Dates

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-October 2018.[2]

Pfizer has sodium phosphate 3 mmol/mL 15 mL vials on back order and the company estimates a release date of 2nd quarter 2019.[3]




Valsartan and Hydrochlorothiazide Tablets October 12, 2018 Reason for the Shortage

Several drug products containing valsartan were recalled due to an unexpected impurity found in the active pharmaceutical ingredient manufactured by a third party. The impurity is N-nitrosodimethylamine (NDMA) and is classified as a probably human carcinogen. Additional information is available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm.

Solco and Teva valsartan/hydrochlorothiazide tablets were affected by the recall. Detailed information on the products is available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf.

Solco and Teva discontinued valsartan/hydrochlorothiazide tablets in July 2018.

Alembic, Aurobindo, Lupin, Mylan, Macleods, and Novartis are not affected by this recall.

Repackagers may have some presentations affected depending on the source supplier.

Mylan is discontinuing valsartan/hydrochlorothiazide 160 mg/12.5 mg in 500 count bottles Estimated Resupply Dates

Aurobindo has valsartan/hydrochlorothiazide presentations in 500 count and 1000 count bottles on back order and the company cannot estimate a resupply date. Valsartan/hydrochlorothiazide presentations in 90 count bottles are on allocation.

Mylan has valsartan/hydrochlorothiazide 160 mg/25 mg tablets in 90 count and 500 count bottles on back order and the company estimates a resupply date of mid-October 2018. The 80 mg/12.5 mg tablets in 90 count and 320 mg/25 mg tablets in 90 count and 500 count bottles are on back order and the company estimates a resupply date of late-October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=445 Vecuronium Bromide Injection October 12, 2018 Reason for the Shortage

Pfizer has vecuronium on shortage due to manufacturing delays.[1-2]

Teva has vecuronium on allocation due to increased demand.[3]

Pfizer sold vecuronium injection to Mylan Institutional in December 2013.[4-5]

Ben Venue has stopped production in its plant in Bedford, Ohio and closed in 2014.[6]

Sun Pharma has vecuronium available.[7]

Sagent is not marketing vecuronium 10 mg and 20 mg vials.[8]

Fresenius Kabi has vecuronium available.[9] Estimated Resupply Dates

Mylan Institutional has vecuronium 20 mg vials on back order with an estimated release date of late-January to early-February 2019.[5]

Pfizer has vecuronium 10 mg and 20 mg vials on back order and the company estimates a release date of 3rd quarter 2019.[2]

Teva has vecuronium 10 mg vials on allocation.[3] https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=167



Asparaginase Erwinia chrysanthemi October 11, 2018 Reason for the Shortage

Jazz Pharmaceuticals did not provide a reason for the shortage. Estimated Resupply Dates

Jazz Pharmaceuticals has Erwinaze 10,000 unit vials in 1 count and 5 count on back order and the company estimates a release date of mid-November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=482 Enoxaparin Sodium Injection October 11, 2018 Reason for the Shortage

Actavis has enoxaparin available.

Amphastar has enoxaparin on intermittent back order due to increased demand.


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. Estimated Resupply Dates

Amphastar has enoxaparin 40 mg/0.4 mL and 60 mg/0.6 mL prefilled syringes on intermittent back order and is shipping the product when available.

Fresenius Kabi has enoxaparin 40 mg/0.4 mL and 80 mg/0.8 mL prefilled syringes on back order and the company estimates release dates of mid-October 2018. Check wholesalers for inventory. Enoxaparin 100 mg/mL 1 mL and 150 mg/mL 1 mL prefilled syringes are available with short expiration dating (< 5 months for the 150 mg/mL 1 mL syringes and < 8 months for the 100 mg/mL 1 mL syringes).

Sandoz has discontinued enoxaparin prefilled syringes. They continue to supply product to customers according to forecast until their supply is depleted.

Sanofi-Aventis has Lovenox 120 mg/0.8 mL prefilled syringes on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=466 Ketorolac Injection October 11, 2018 Reason for the Shortage

Alvogen did not provide a reason for the shortage.[1]

Amphastar did not provide a reason for the shortage.[2]

Athenex did not provide a reason for the shortage.[3]

BD RX is now part of Fresenius Kabi.[4]

Fresenius Kabi has most ketorolac presentations available.[5]

Pfizer has ketorolac injection on back order due to manufacturing delays.[6]

Sagent states the reason for the shortage is manufacturing delay.[7]



Hikma did not provide a reason for the shortage.[8]

Ben Venue closed its plant in Bedford, Ohio in July 2014.[9]

Virtus has ketorolac injection available.[10]

FDA imposed an import ban in mid-2013 on several Wockhardt products including ketorolac.[11]

Sprix Nasal Spray is not affected by this shortage.[12] Estimated Resupply Dates

Alvogen has 15 mg/mL 1 mL vials and 30 mg/mL 1 mL vials on on allocation. The 30 mg/mL 2 mL vials are on back order with an estimated release date of late-November 2018.1

Amphastar has ketorolac 30 mg/mL 1 mL vials on back order and the company cannot estimate a release date.[2]

Athenex has ketorolac 15 mg/mL 1 mL vials on back order and the company estimates a release date of October 2018.[3]

Fresenius Kabi has ketorolac 15 mg/mL 1 mL and 30 mg/mL 1 mL prefilled syringes on back order with an estimated release date of the first quarter of 2019. There are limited quantities of ketorolac 15 mg/mL 1 mL prefilled syringes available with short expiration dating (< 9 months). The 30 mg/mL 1 mL prefilled syringes are also available in limited quantities with short expiration dating (< 7 months).[5]

Pfizer has ketorolac 30 mg/mL 1 mL Carpuject syringes, 30 mg/mL 2 mL Carpuject syringes for intramuscular injection, and 30 mg/mL 1 mL iSecure syringes on back order and the company estimates a release date of 2019.[6]

Sagent has ketorolac 15 mg/mL 1 mL vials, 30 mg/mL 1 mL vials, and 30 mg/mL 2 mL vials for intramuscular injection on back order and the company cannot estimate a release date.[7]

Hikma has ketorolac 15 mg/mL 1 mL vials on intermittent back order and the company is releasing supplies as they become available.[8]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=113 Vancomycin Hydrochloride Injection October 11, 2018 Reason for the Shortage

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]

Sagent has vancomycin injection on shortage due to manufacturing delays and increased demand.[9]

Baxter has vancomycin injection available.[7]

Samson Medical Technologies has vancomycin injection available.[8] Estimated Resupply Dates

Fresenius Kabi has vancomycin 5 gram and 10 gram vials on intermittent back order with regular releases. The 750 mg vials are on back order and the company estimates a release date of mid-October 2018.3



Pfizer has vancomycin 500 mg vials, 500 mg ADD-Vantage vials, 750 mg ADD-Vantage vials and 1 gram vials available in limited supply. The 750 mg ADD-Vantage vials have an expiration date of March 2019. The 750 mg vials are on back order and the company estimates a release date of November 2018. The 5 gram vials are on back order and the company estimates a release date of October 2018. The 1 gram ADD-Vantage vials are on back order and the company estimates a release date of November 2018. The 10 gram vials are on back order and the company cannot estimate a release date.[4]

Sagent has vancomycin 5 gram and 10 gram vials on back order and the company estimates a release date of October 2018.[9]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=25 Cisplatin Injection October 10, 2018 Reason for the Shortage

Athenex has cisplatin available.[1]

Fresenius Kabi has cisplatin available.[2]

Mylan Institutional discontinued cisplatin in January 2018.[3]

Teva had cisplatin on allocation due to increased demand.[4]

WG Critical Care has cisplatin available.[5] Estimated Resupply Dates

Fresenius Kabi has cisplatin 1 mg/mL 200 mL vials available with short-expiration dating of <9 months.[2]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=96 5% Dextrose Injection (PVC-free and DEHP-free) October 9, 2018 Reason for the Shortage

ICU Medical states the shortage is due to increased demand and manufacturing delays. ICU Medical discontinued the 500 mL VisIV bags in 2011 due to leaking around the administration and medications ports.

ICU Medical is now the IV fluid business of Pfizer after the acquisition of Hospira.

Baxter is not currently marketing 5% dextrose PVC/DEHP-free bags.

BBraun has 5% dextrose PVC/DEHP-free bags on shortage due to manufacturing delays. Estimated Resupply Dates

BBraun has 5% dextrose 250 mL PVC/DEHP-free bags on allocation to current customers. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=314 Alpha-1 Proteinase Inhibitor October 9, 2018 Reason for the Shortage

CSL Behring has Zemaira available.



The other alpha-1 proteinase inhibitors such as Aralast and Prolastin-C are not affected by this shortage.


N/A https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=452 Calcitriol Injection October 9, 2018 Reason for the Shortage


American Regent has not had product for several years. Estimated Resupply Dates

Akorn has calcitriol 1 mcg/mL 1 mL ampules on back order and the company estimates a release date in early- to mid-November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=464 Dorzolamide Ophthalmic Solution October 9, 2018 Reason for the Shortage

Akorn has dorzolamide ophthalmic solution on shortage due to manufacturing delays.

Merck did not provide a reason for the shortage.

Sandoz did not provide a reason for the shortage.

Teva discontinued dorzolamide ophthalmic solution in April 2018.

Bausch Health has dorzolamide ophthalmic solution on shortage due to manufacturing delays. Estimated Resupply Dates

Akorn has dorzolamide 2% ophthalmic solution on allocation.

Bausch Health has dorzolamide 2% ophthalmic solution on back order and the company estimates a release date in late-November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=359 Gentamicin Sulfate Ophthalmic Ointment October 9, 2018 Reason for the Shortage

Akorn has Gentak ophthalmic ointment on shortage due to manufacturing delays.

Gentamicin ophthalmic solutions are not affected by this shortage. Estimated Resupply Dates

Akorn has Gentak 3.5 gram tubes on back order and the company cannot estimate a release date.




Hydroxyethyl Starch in Sodium Chloride Injection October 9, 2018 Reason for the Shortage

BBraun has Hespan available now.

Pfizer did not provide a reason for the shortage of 6% hetastarch in 0.9% sodium chloride injection.

Pfizer has Voluven available. Estimated Resupply Dates

Pfizer has 6% hetastarch in 0.9% sodium chloride injection in 500 mL bags on back order and the company estimates a release date of November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=454 Midodrine Tablets October 9, 2018 Reason for the Shortage

Impax discontinued midodrine tablets in July 2018.

Mylan has midodrine tablets available.

Sandoz discontinued midodrine tablets in mid-2018.

Upsher-Smith has midodrine tablets available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=439 Multiple Vitamins for Infusion October 9, 2018 Reason for the Shortage

Pfizer states the shortage is due to manufacturing delays.

Baxter has all presentations fully available at this time. Estimated Resupply Dates

Pfizer has M.V.I. Adult 2 X 5 mL Dual vials on back order with an estimated release date of October 2018. There is limited short-dated product available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=69 Sterile Talc October 9, 2018 Reason for the Shortage

Lymol has Sclerosol and talc powder on shortage due to manufacturing delays.[1]

Novatech SA has Steritalc powder available.[2] Estimated Resupply Dates

Lymol has Sclerosol and talc powder on long-term back order and the company cannot estimate a release date.[1]




Sterile Water for Injection Large Volume Bags October 9, 2018 Reason for the Shortage

Baxter had sterile water for injection on shortage due to manufacturing delays.

BBraun did not provide a reason for the shortage.

ICU Medical had sterile water for injection on shortage due to increased demand. Estimated Resupply Dates

BBraun has sterile water for injection 250 mL and 500 mL bags on allocation to current customers.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=368 Sufentanil Injection October 9, 2018 Reason for the Shortage

Akorn has Sufenta injection on shortage due to increased demand for the product.


Pfizer has sufentanil injection on shortage due to manufacturing delays. Estimated Resupply Dates

Akorn has Sufenta 50 mcg/mL 2 mL, and 5 mL ampules on allocation.

Hikma has sufentanil 50 mcg/mL 5 mL ampules on back order and the company cannot estimate a release date.

Pfizer has sufentanil 50 mcg/mL 5 mL vials on back order and the company estimates a release date of November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=376 Acetylcysteine Oral and Inhalation Solution October 8, 2018 Reason for the Shortage

American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.

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. Estimated Resupply Dates

American Regent has acetylcysteine solution 100 mg/mL 10 mL and 200 mg/mL 10 mL and 30 mL vials on back order and the company cannot estimate a release date.

Fresenius Kabi has acetylcysteine solution 200 mg/mL 4 mL and 10 mL vials on back order and the company estimates a release date of late-October 2018. The 100 mg/mL 4 mL and 10 mL vials are on back order and the company estimates a release date of late-October 2018.




Amino Acid Products October 8, 2018 Reason for the Shortage

Baxter has most amino acid products available.[1]

Baxter had amino acid products on allocation due to delays because of Hurricane Maria in Puerto Rico.

BBraun has discontinued FreAmine HBC, Nephramine, and Trophamine 6%.[2]

ICU Medical discontinued several Aminosyn products in September 2018.[3] Estimated Resupply Dates

Baxter has 10% Premasol sulfite-free 1000 mL injection on back order and the company cannot estimate a release date.[1]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=297 Calcium Chloride Injection October 8, 2018 Reason for the Shortage

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 and 100 mg/mL 10 mL LifeShield syringes on back order and the company estimates a release date of November 2018 for the Ansyr syringes and October 2018 for the LifeShield syringes.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=48 Calcium Gluconate Injection October 8, 2018 Reason for the Shortage

American Regent has calcium gluconate on shortage due to manufacturing delays.

Fresenius Kabi has calcium gluconate available. Estimated Resupply Dates

American Regent has calcium gluconate 100 mg/mL 50 mL and 100 mL vials on back order and the company cannot estimate a release date.

Fresenius Kabi has calcium gluconate 100 mg/mL 100 mL vials on back order and the company estimates a release date of mid-October 2018. Check wholesalers for inventory.




Dexamethasone Sodium Phosphate Injection October 8, 2018 Reason for the Shortage

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 intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has dexamethasone sodium phosphate 4 mg/mL 1 mL prefilled syringes on back order and the company estimates a release date of 1st quarter 2019. The 10 mg/mL 1 mL preservative-free vials are on back order and the company estimates a release date of late-October 2018. The 4 mg/mL 1 mL vials are on back order and the company estimates a release date of mid-October 2018.

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.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=140 Diphenhydramine Injection October 8, 2018 Reason for the Shortage

Pfizer has dipehnhydramine injection on shortage due to manufacturing delays.


Fresenius Kabi has diphenhydramine injection on shortage due to a short-term manufacturing delay.


Fresenius Kabi has diphenhydramine 50 mg/mL 1 mL vials on back order and the company estimates a release date of mid-October 2018. The 50 mg/mL 1 mL syringes are on back order and the company estimates a release date of mid-December 2018.

Hikma has diphenhydramine 50 mg/mL 1 mL vials on back order and the company estimates a release date of mid-October to early-November 2018.

Mylan Institutional has diphenhydramine 50 mg/mL 10 mL vials on back order and the company estimates a release date of early-October 2018.

Pfizer has diphenhydramine 50 mg/mL 1 mL vials on back order and the company estimates a release date of 2019.




Famotidine Injection October 8, 2018 Reason for the Shortage

Ben Venue stopped production in its plant in Bedford, Ohio and closed in July 2014.[1]

Hikma did not provide a reason for the shortage.[2]

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 has famotidine premixed bags available.[6] Estimated Resupply Dates

Fresenius Kabi has famotidine 20 mL vials on back order and the company estimates a release date of mid-October 2018. Check wholesalers for inventory.[5]

Mylan Institutional has famotidine 2 mL, 4 mL, and 20 mL vials on back order and the company estimates a release date of late-October 2018 for the 2 mL and 20 mL vials and late-December 2018 for the 4 mL vials.[4]

Hikma has famotidine 4 mL vials on back order and the company estimates a release date of mid- to late-October 2018. The 20 mL vials are on allocation.[2]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=166 Lidocaine Injection October 8, 2018 Reason for the Shortage

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. Estimated Resupply Dates

AuroMedics has 1% lidocaine 2 mL and 5 mL ampules and 2 mL, 5 mL, and 30 mL vials on intermittent back order and the company is releasing product as it becomes available. AuroMedics has 2% lidocaine 2 mL ampules and 2 mL and 5 mL vials on intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has 0.5% Xylocaine 50 mL vials on back order and the company cannot estimate a release date. The 0.5% Xylocaine 50 mL MPF vials are on back order and the company estimates a release date of early- to mid-October 2018. The 1% lidocaine 2 mL and 10 mL vials are on back order and the company estimates a release date of late-October 2018 for the 2 mL vials and mid-October 2018 for the 10 mL vials. The 1% Xylocaine 20 mL and 50 mL vials are on back order and the company estimates a release date of early- to mid-October 2018. The 1% Xylocaine-MPF 2 mL, 5 mL, and 30 mL vials are on back order and the company estimates a release date of early- to mid-October 2018 for the 2 mL vials, mid-October 2018 for the 5 mL vials, and late-November 2018 for the 30 mL vials. The 1% Xylocaine-MPF 10 mL ampule sterile packs are on back order and the company estimates a release date of late-December 2018. 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 20 mL ampules are on back order and the company estimates a release date of late-December 2018. The 2% Xylocaine 10 mL, 20 mL, and 50 mL vials are on back order and the company estimates a release date of late-October 2018 for the 10 mL vials, early- to mid-October 2018 for the 20 mL vials, and mid-October 2018 for the 50 mL vials. The 2% Xylocaine-MPF 2 mL vials are on back order and the company estimates a release date of early- to mid-October 2018. The 2% Xylocaine-MPF 10 mL ampules are on back order and the company estimates a release date of late-December 2018. The 2% lidocaine 2 mL and 5 mL vials are on back order and the company estimates a release date of early-November 2018. Check wholesalers for inventory.

Pfizer has 0.5% lidocaine 50 mL tear top vials on back order and the company estimates a release date of December 2018. The 0.5% lidocaine flip top vials are on back order and the company estimates a release date of February 2019. The 1% lidocaine 2 mL preservative-free ampules on back order and the company estimates a release date of October 2018. The 1% lidocaine 5 mL preservative-free ampules are on back order and the company estimates a release date of 2020. The 1% lidocaine 20 mL vials and 30 mL preservative-free vials are on back order and the company estimates a release date of October 2018. The 1% lidocaine 50 mL vials are on back order and the company estimates a release date of October 2018. The 1% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of December 2018. The 1% lidocaine 5 mL Ansyr syringes are on back order and the company estimates a release date of November 2018. The 2% lidocaine 10 mL ampules are on back order and the company estimates a release date of October 2018. The 2% lidocaine 5 mL vials are on back order and the company estimates a release date of 2019. The 2% lidocaine 20 mL and 50 mL vials are on back order and the company estimates a release date of October 2018. The 2% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of December 2018. The 2% lidocaine 5 mL Ansyr syringes are on back order and the company estimates a release date of October 2018. The 4% lidocaine 5 mL ampules are on back order and the company estimates a release date of December 2018.

Hikma has 1% lidocaine 5 mL preservative-free vials on back order and the company estimates a release date of early-October 2018. The 1% lidocaine 50 mL vials are on allocation. The 2% lidocaine 5 mL preservative-free vials are on back order and the company estimates a release date of early-October 2018. The 2% lidocaine 50 mL vials are on back order and the company estimates a release date of mid-October to early-November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=88 Metoclopramide Injection October 8, 2018 Reason for the Shortage

Pfizer had metoclopramide injection on shortage due to increased demand.

Teva had metoclopramide injection on shortage due to increased demand.

Fresenius Kabi has metoclopramide injection on shortage due to increased demand. Estimated Resupply Dates

Fresenius Kabi has metoclopramide 5 mg/mL 2 mL syringes on back order and the company estimates a release date of mid-December 2018.




Morphine Injection October 8, 2018 Reason for the Shortage

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 states the shortage is due to manufacturing delays. Pfizer discontinued morphine ADD-Vantage vials in January 2017.[3]

Pfizer anticipates 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. Pfizer expects the shortage of prefilled syringe products to recover by late-first quarter 2018.[3]

Hikma did not provide a reason for the shortage. West-Ward is not actively marketing the 15 mg/mL 1 mL vials or the 8 mg/mL 1 mL vials (NDC 00641-6075-25). They are still marketing the 8 mg/mL 1 mL vials with NDC 00641-6126-25.[4]


Fresenius Kabi has morphine 2 mg/mL 1 mL syringes and 4 mg/mL 1 mL vials on back order and the company estimates a release date of early- to mid-October 2018. The morphine 4 mg/mL 1 mL syringes are on back order and the company estimates a release date of 1st quarter 2019. The morphine 5 mg/mL 1 mL syringes are on back order and the company cannot estimate a release date. The 2 mg/mL 1 mL vials are on back order and the company estimates a release date of late-November 2018. The 5 mg/mL 1 mL vials and 8 mg/mL 1 mL vials are on back order and the company cannot estimate a release date. The 10 mg/mL 1 mL vials are on back order and the company estimates a release date of mid-November 2018. Check wholesalers for inventory.[2]

Pfizer has morphine 2 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date of early-December 2018. The 4 mg/mL 1 mL Carpuject syringes 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 Carpuject syringes, 8 mg/mL 1 mL iSecure syringes, 10 mg/mL 1 mL iSecure syringes, and 10 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of June 2019. The 50 mg/mL 50 mL vials are on back order and the company estimates a release date of October 2018.[3]

Hikma has morphine 4 mg/mL, 8 mg/mL, and 10 mg/mL 1 mL vials on allocation. Infumorph 10 mg/mL 20 mL ampules and 25 mg/mL 20 mL ampules are on back order and the company estimates a release date of November to December 2018. Duramorph 1 mg/mL 10 mL ampules are on allocation. Duramorph 0.5 mg/mL 10 mL ampules are on allocation.[4]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=41 Norepinephrine Bitartrate Injection October 8, 2018 Reason for the Shortage

Baxter did not provide a reason for the shortage.

Pfizer has Levophed on shortage due to manufacturing delays.



Teva has norepinephrine injection on allocation due to increased demand. Estimated Resupply Dates

Pfizer has Levophed 1 mg/mL 4 mL ampules on back order and the company estimates a release date of 2020.

Teva has norepinephrine 1 mg/mL 4 mL vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=292 Ondansetron Hydrochloride October 8, 2018 Reason for the Shortage

Apotex did not provide a reason for the shortage.

Athenex had ondansetron injection on shortage due to increased demand.


Fresenius Kabi has ondansetron injection available.

Heritage has ondansetron on shortage due to increased demand.



Pfizer has ondansetron injection on shortage due to manufacturing delays.

Sagent has ondansetron injection on shortage due to increased demand.

Novartis discontinued Zofran 20 mL vials in May 2018. Estimated Resupply Dates

Apotex has ondansetron 2 mg/mL 2 mL vials on back order and the company cannot estimate a release date.

AuroMedics has ondansetron 2 mg/mL 2 mL and 20 mL vials on intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has ondansetron 2 mg/mL 20 mL vials with a short-expiration date (<8 months). The 2 mg/mL 2 mg/mL 2 mL prefilled syringes are on back order and the company estimates a release date of late-October 2018.

Heritage has 2 mg/mL 2 mL vials on back order and the company estimates a release date in October 2018. The 20 mL vials are on allocation.

Hikma has ondansetron 2 mg/mL 20 mL vials in single count (NDC 00143-9890-01) and 10 count on back order and the company estimates a release date in mid- to late-October 2018. The 2 mg/mL 20 mL vials (NDC 00641-6079-01) are on back order and the company estimates a release date of October 2018. The 2 mg/mL 2 mL vials are on allocation.

Mylan Institutional has ondansetron 2 mg/mL 2 mL and 20 mL vials on back order and the company estimates a release date of late-October to early-November 2018 for the 2 mL vials and late-October 2018 for the 20 mL vials.

Pfizer has ondansetron 2 mg/mL 2 mL vials on back order and the company estimates a release date of October 2018. The 2 mg/mL 20 mL vials are on back order and the company estimates a release date of November 2018. The 2 mg/mL 2 mL iSecure syringes are on back order and the company estimates a release date of 2019.

Sagent has ondansetron 2 mg/mL 2 mL vials on back order and the company estimates a release date of October 2018. The 2 mg/mL 20 mL vials are on back order and the company cannot estimate a release date.



https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=405 Sodium Fluoride Chewable Tablets October 8, 2018 Reason for the Shortage

Kirkman has sodium fluoride chewable tablets unavailable because their supplier, Medical Product Laboratory, has stopped manufacturing sodium fluoride tablets. Kirkman is looking for a new supplier.

PureTek states sodium fluoride chewable tablets are available. Estimated Resupply Dates

Kirkman has sodium fluoride tablets unavailable and the company cannot estimate a resupply date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=481 2% Lidocaine Hydrochloride Topical Jelly October 5, 2018 Reason for the Shortage

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. Estimated Resupply Dates

Akorn has 2% lidocaine jelly 5 mL and 30 mL tubes on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=400 Belladonna and Opium Suppositories October 5, 2018 Reason for the Shortage

Perrigo had belladonna and opium suppositories on shortage because they were waiting to get more raw ingredient.


Perrigo has belladona and opium 16.3 mg/30 mg and 16.3 mg/60 mg suppositories available https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=425 Carbidopa and Levodopa Extended-Release Tablets October 5, 2018 Reason for the Shortage

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 50 mg/200 mg extended-release tablets in 100 count unit-dose packs on back order and the company estimates a release date of early-November 2018. The 25 mg/100 mg extended release tablets in 100 count unit-dose packs are on back order and the company estimates a release date of early-October 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 late-October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=349 Cefazolin Injection October 5, 2018 Reason for the Shortage

Apotex has discontinued all presentations except cefazolin 1 gram vials.


BBraun has cefazolin on shortage due to manufacturing delays.

Fresenius Kabi has most cefazolin products available.

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. Estimated Resupply Dates

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,1 gram, 10 gram, and 20 gram vials on back order and the company estimates a release date of mid- to late-November 2018 for the 500 mg vials, mid-December 2018 for the 1 gram and 20 gram vials, and mid-January 2019 for the 10 gram vials.

Pfizer has 1 gram and 10 gram vials on back order and the company estimates a release date of 2019. The 1 gram ADD-Vantage vials are available in limited supply.

Sagent has cefazolin 500 mg, 1 gram, and 10 gram vials on back order and the company estimates a release date of December 2018 for the 500 mg vials, October 2018 for the 1 gram vials, and November 2018 for the 10 gram vials.

Sandoz has cefazolin 500 mg and 1 gram vials on back order and the company estimates a release date of late-October 2018 for the 500 mg vials and early- to mid-October 2018 for the 1 gram vials.

Hikma has cefazolin 500 mg vials on back order and the company cannot estimate a release date. The 1 gram vials are on allocation. The 10 gram vials are on back order and the company estimates a release date of mid-October to early-November 2018.



WG Critical Care has cefazolin 1 gram vials on intermittent back order and the company is releasing product as it becomes available. The 10 gram vials are on back order and the company estimates a release date of late-November 2018. The 500 mg vials are on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=432 Cefepime Injection October 5, 2018 Reason for the Shortage


Baxter had cefepime on shortage due to increased demand.

BBraun has cefepime on shortage due to manufacturing delays.

Fresenius Kabi had cefepime injection on shortage due to manufacturing delays.

Pfizes has Maxipime on shortage due to manufacturing delays.

Sagent had cefepime injection on shortage due to manufacturing delays.

Sandoz discontinued cefepime injection in early-2016.

WG Critical Care had cefepime injection on shortage due to increased demand. Estimated Resupply Dates

BBraun has cefepime 1 gram and 2 gram premixed bags on allocation.

Pfizer has Maxipime 1 gram vials, 2 gram vials, 1 gram ADD-Vantage vials, and 2 gram ADD-Vantage vials on back order and the company estimates a release date of 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=59 Cefoxitin Sodium Injection October 5, 2018 Reason for the Shortage


BBraun has cefoxitin on allocation due to increased demand.

Fresenius Kabi not provide a reason for the shortage.


Sagent has cefoxitin on shortage due to increased demand.

WG Critical Care did not provide a reason for the shortage. Estimated Resupply Dates

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 vials on allocation.

Fresenius Kabi has cefoxitin 2 gram vials on back order and the company estimates a release date of early- to mid-January 2019.

Hikma has cefoxitin 1 gram vials on back order and the company estimates a release date of mid-October to early-November 2018.

Sagent has cefoxitin 2 gram vials on back order and the company estimates a release date of January 2019.



WG Critical Care has cefoxitin 2 gram and 10 gram vials on back order and the company estimates a release date of early-October 2018 for the 2 gram vials and late-October 2018 for the 10 gram vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=271 Methadone Injection October 5, 2018 Reason for the Shortage


Mylan Institutional has methadone injection available. Estimated Resupply Dates

Akorn has methadone injection on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=358 0.9% Sodium Chloride Large Volume Bags October 4, 2018 Reason for the Shortage

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]

ICU Medical cited increased demand as the reason for the shortage.[3]

Fresenius Kabi is no longer importing product.[8]

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.


BBraun has 0.9% sodium chloride 250 mL, 500 mL, and 1,000 mL PVC/DEHP-free bags on allocation to current customers.[2]

ICU Medical has 0.9% sodium chloride 250 mL PVC/DEHP-free bags on back order and the company cannot estimate a release date. [3]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=76 0.9% Sodium Chloride Small Volume Bags (< 150 mL) October 4, 2018 Reason for the Shortage

Baxter has 0.9% sodium chloride small volume bags available.

BBraun has 0.9% sodium chloride small volume bags on shortage due to increased demand.

ICU Medical has 0.9% sodium chloride small volume bags on shortage due to increased demand.

Pfizer did not provide a reason for the shortage. Estimated Resupply Dates

BBraun has all 0.9% sodium chloride small volume bags on allocation to current customers only.



ICU Medical has 0.9% sodium chloride 25 mL and 100 mL bags on back order and the company cannot estimate a release date.

Pfizer has 0.9% sodium chloride 50 mL Add-Vantage bags and 100 mL Add-Vantage bags available in limited quantities. The 50 mL preservative-free vials are on back order and the company estimates a release date of October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=352 5% Dextrose Injection October 4, 2018 Reason for the Shortage

Baxter has 5% dextrose injection available.

ICU Medical states the shortage is due to increased demand.

Pfizer states that the shortage was due to increased demand.

ICU Medical is now the IV fluid business of Pfizer after the acquisition of Hospira. Pfizer continues to market the ADD-vantage product.


ICU Medical has 5% dextrose 250 mL 2 port bags on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=303 Amiodarone Injection October 4, 2018 Reason for the Shortage

Baxter has Nexterone premixed bags on shortage due to manufacturing delays.



Mylan Institutional has amiodarone 50 mg/mL 3 mL, 9 mL, and 18 mL vials on back order and the company estimates release dates of mid-October 2018 for the 3 mL and 9 mL vials and late-October 2018 for the 18 mL vials.

Sagent has 50 mg/mL 3 mL vials available with an expiry of February 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=374 Azithromycin Injection October 4, 2018 Reason for the Shortage


Pfizer has azithromycin injection on shortage due to manufacturing delays.

Sun Pharma did not provide a reason for the shortage. Estimated Resupply Dates



Pfizer has azithromycin 500 mg ADD-Vantage vials on back order and the company estimates a release date of 2019. Zithromax 500 mg vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=380 Ceftriaxone Sodium Injection October 4, 2018 Reason for the Shortage

Apotex has ceftriaxone available.

Fresenius Kabi states the reason for the shortage was increased demand.

Pfizer has 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 relaunched their ceftriaxone presentations in October 2017. Estimated Resupply Dates

Lupin has all ceftriaxone presentations on allocation.

Hikma has ceftriaxone 500 mg and 2 gram vials on back order and the company cannot estimate a release date. The 250 mg and 1 gram vials are on back order and the company estimates a release date of mid- to late-October 2018 for the 250 mg vials and November to December 2018 for the 1 gram vials.

Sagent has ceftriaxone 2 gram vials on back order and the company estimates a release date of January 2019. The 500 mg vials are available with short expiration dating (April 2019).

Sandoz has ceftriaxone 2 gram vials on back order and the company estimates a release date in mid-October 2018.

Wockhardt has all ceftriaxone presentations on back order and the company cannot estimate a release date. Check with your wholesaler for availability.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=86 Cefuroxime Sodium Injection October 4, 2018 Reason for the Shortage

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. Estimated Resupply Dates

Sagent has cefuroxime 750 mg vials on back order and the company cannot estimate a release date.

Hikma has cefuroxime 750 mg vials and 7.5 gram vials on back order and the company estimates a release date of mid- to late-October 2018.




Ciprofloxacin Injection October 4, 2018 Reason for the Shortage

Pfizer has ciprofloxacin injection on shortage due to manufacturing delays.

Baxter (formerly Claris) has ciprofloxacin injection available. Estimated Resupply Dates

Pfizer has ciprofloxaxin 2 mg/mL 200 mL premixed bags available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=396 Clindamycin Phosphate Injection October 4, 2018 Reason for the Shortage

Alvogen refuses to provide availability information.


Baxter has clindamycin injection available.


Pfizer has Cleocin available. Sagent had clindamycin on shortage due to manufacturing delays. Sandoz has clindamycin injection available. Estimated Resupply Dates

Akorn has clindamycin 900 mg/50 mL in 5% dextrose premixes on back order and the company cannot estimate a release date. The 300 mg/50 mL and 600 mg/50 mL in 5% dextrose are available in limited supply.

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 2019. Cleocin 900 mg/50 mL in 5% dextrose premixed bags and 600 mg/50 mL in 5% dextrose premixed bags are on back order and the company cannot estimate a release date. The 150 mg/mL 4 mL vials are available in limited supply.

Fresenius Kabi has clindamycin 150 mg/mL 60 mL vials available with an expiration date of <5 months.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=97 Lactated Ringer’s Injection October 4, 2018 Reason for the Shortage


BBraun states the reason for the shortage is increased demand.

ICU Medical states the reason for the shortage is increased demand. Estimated Resupply Dates

Baxter has lactated ringer's 1000 mL bags on allocation.

BBraun has lactated ringer's injection solution and lactated ringer's with 5% dextrose injection solution products on allocation to current customers.



ICU Medical has lactated ringer's with 5% dextrose 1000 mL bags on intermittent back order and the company is releasing supplies as they become available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=361 Lorazepam Tablets October 4, 2018 Reason for the Shortage

Aurobindo did not provide a reason for the shortage.

Leading has lorazepam tablets on shortage due to increased demand.

Major did not provide a reason for the shortage.

Mylan has discontinued all bottled presentations.

Mylan Institutional did not provide a reason for the shortage for the unit-dose blister packs.

Sandoz discontinued all lorazepam presentations.

Teva did not provide a reason for the shortage. Estimated Resupply Dates

Aurobindo has lorazepam 0.5 mg tablets in 500 count, 1 mg tablets in 500 count, and 2 mg tablets in 100 count on back order and the company cannot estimate a release date.

Leading has all lorazepam tablets on allocation.

Major has lorazepam 0.5 mg tablets in 100 count bottles on back order and the company cannot estimate a release date. The 1 mg tablets in 100 count bottles are on back order and the company estimates a release date of late-November 2018.

Mylan Institutional has lorazepam 0.5 mg, 1 mg, and 2 mg tablets in 100 count unit-dose packs on back order and the company estimates a release date of early-December 2018.

Teva has all lorazepam tablets except for the 2 mg 100 count bottles on back order and the company estimates a release date of mid-October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=480 Methocarbamol Tablets October 4, 2018 Reason for the Shortage

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. Estimated Resupply Dates

Camber has methocarbamol 750 mg tablets in 100 count and 500 count on intermittent back order and the company is releasing product as it becomes available. The 500 mg tablets in 100 count and 500 count are on back order and the company estimates a release date of mid-October 2018.

Hikma has methocarbamol 500 mg tablets in 100 count available with short expiration dating of

Solco has methocarbamol 500 mg tablets in 100 count and 500 count and 750 mg tablets in 100 count and 500 count on allocation.

Virtus has all methocarbamol tablets on back order and the company cannot estimate a release date.



Endo has Robaxin 500 mg amd 750 mg tablets in 100 count on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=423 Methylene Blue October 4, 2018 Reason for the Shortage

Akorn has methylene blue on shortage due to manufacturing delays.[1]

American Regent has recently launched an FDA approved presentation, ProvayBlue and product is available.[2]


Akorn has methylene blue 10 mg/mL 1 mL vials on back order and the company cannot estimate a release date. There are short-dated 10 mL vials with an expiration date of August 2019.[1]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=47 Metronidazole Hydrochloride Injection October 4, 2018 Reason for the Shortage

Pfizer has metronidazole injection on shortage due to manufacturing delay.

BBraun did not provide a reason for the metronidazole injection shortage. Estimated Resupply Dates

Baxter has metronidazole 100 mL bags (NDC 36000-0001-24) on back order and the company cannot estimate a release date.

BBraun has metronidazole 100 mL bags on allocation to current customers.

Pfizer has metronidazole 100 mL bags in 24 count available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=316 Mineral Oil and Petrolatum Ophthalmic Ointment October 4, 2018 Reason for the Shortage

Allergan states the shortage is due to production delays.

Bausch Health did not provide a reason for the shortage.

Major did not provide a reason for the shortage.

Alcon states the shortage is due to manufacturing issues.

Perrigo did not provide a reason for the shortage.

Rugby did not provide a reason for the shortage Estimated Resupply Dates

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 the company cannot estimate a release date.



Bausch Health has Soothe Night Time ointment on back order and the company estimates a release date in mid-October 2018.

Major has Lubrifresh PM ointment 3.5 gram tubes on back order and the company cannot estimate a release date.

Rugby has Artificial Tears 3.5 gram tubes on back order and the company cannot estimate a release date.

Alcon has Genteal Tears Night-Time ointment in 3.5 gram tubes on back order and the company cannot estimate a release date. Systane Lubricating Night ointment is on intermittent back order and the company is releasing supplies as they become available.

Perrigo has Puralube ointment in 3.5 gram and 1 gram tubes on back order and the company estimates release dates in January 2019 for the 3.5 gram tubes and October 2018 for the 1 gram tubes.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=435 Pentostatin Injection October 4, 2018 Reason for the Shortage

Pfizer has Nipent on shortage due to manufacturing delays. Estimated Resupply Dates

Pfizer has Nipent 10 mg vials on back order and the company estimates a release date of March 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=474 Potassium Chloride Injection October 4, 2018 Reason for the Shortage

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.


Baxter has potassium chloride 20 mEq/1000 mL in lactated ringer's and 5% dextrose on back order and the company cannot estimate a release date.

Fresenius Kabi has potassium chloride 10 mEq/5 mL, 20 mEq/10 mL, and 40 mEq/20 mL vials on back order and the company estimates a release date of early-November 2018 for the 5 mL vials and 10 mL vials, and mid-October 2018 for the 20 mL vials. Check wholesalers for inventory.

ICU Medical has potassium chloride 20 mEq/100 mL in sterile water on back order and the company cannot estimate a release date.



Pfizer has potassium chloride 10 mEq/5 mL vials and 40 mEq/20 mL vials on back order and the company estimates a release date in November 2018. The 20 mEq/10 mL vials are on back order and the company estimates a release date in October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=12 Rosuvastatin Calcium Tablets October 4, 2018 Reason for the Shortage

Biocon, Glenmark, Mylan, Sandoz, and Rising did not provide a reason for the shortage.


Biocon has rosuvastatin tablets in limited supply.

Glenmark has rosuvastatin 5 mg tablets on back order and the company cannot estimate a

release date. The 10 mg and 20 mg tablets are on back order and the company estimates a

release date in early- to mid-October 2018. The 40 mg tablets are on back order and the

company estimates a release date in mid-October 2018.

Mylan has rosuvastatin tablets on back order and the company cannot estimate a release date.

Rising has rosuvastatin 5 mg tablets in 90 count bottles on back order and the company cannot

estimate a release date. The 10 mg and 20 mg tablets in 90 count bottles are on allocation.

Sandoz has rosuvastatin tablets on back order and the company estimates a release date in mid-

October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=473 Sincalide Injection October 4, 2018 Reason for the Shortage

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.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=277 Spironolactone Tablets October 4, 2018 Reason for the Shortage

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 presentations on intermittent back order and the company is

releasing supplies as they become available.

Amneal has all spironolactone presentations on back order and the company cannot estimate a

release date.

Cadista has temporarily discontinued spironolactone tablets.

Mylan has spironolactone 25 mg, 50 mg, and 100 mg tablets in 100 count unit dose blister packs

on back order and the company estimates a release date in mid-October 2018 for the 25 mg and

100 mg tablets and early-November 2018 for the 50 mg tablets. The 25 mg tablets in 500 count

are on intermittent back order and the company is releasing supplies as they become available.

The 25 mg and 50 mg tablets in 100 count, 50 mg tablets in 500 count, and 100 mg tablets in

100 count are on back order and the company estimates a release date of late-October 2018 for

the 50 mg tablets (100 count) and mid-December 2018 for the 25 mg, 50 mg (500 count), and

100 mg tablets

Par has most presentations on back order and the company cannot estimate a release date.

Pfizer has Aldactone 100 mg tablets in 100 count on back order and the company estimates a

release date in October 2018. The 50 mg tablets in 100 count are on back order and the

company cannot estimate a release date.

Sun Pharma had most spironolactone presentations on back order, however we were unable to

reach representatives for an update.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=447 Ampicillin Sodium and Sulbactam Sodium Injection October 3, 2018 Reason for the Shortage

Pfizer has discontinued generic ampicillin sulbactam except for the 1.5 gram and 3 gram ADD-

Vantage vials. These are on shortage due to manufacturing delays.

Sagent had ampicillin sulbactam vials on back order due to manufacturing delays.

Sandoz cannot provide a reason for the shortage.

WG Critical Care states the shortage was due to increased demand.


AuroMedics has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back

order and the company cannot estimate a release date.

Fresenius Kabi has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back

order and the company cannot estimate a release date.

Hikma has ampicilin sulbactam 1.5 gram, 3 gram, and 15 gram vials on back order and the

company estimates a release date of mid- to late-October 2018.

Mylan Institutional has ampicillin sulbactam 1.5 gram vials on back order and the company

cannot estimate a release date. The 15 gram vials are on back order and the company estimates

a release date of late-January 2019.



Pfizer has ampicillin sulbactam 3 gram ADD-Vantage vials available in limited supply. Unasyn 3

gram and 15 gram bulk vials are on back order and the company estimates a release date of

October 2018 for the 15 gram vials and November 2018 for the 3 gram vials.

Sandoz has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order

and the company cannot estimate a release date.

Sagent has ampicillin sulbactam 1.5 gram and 3 gram vials on back order and the company

estimates a release date of November 2018 for the 1.5 gram vials and January 2019 for the 3

gram vials.

WG Critical Care has ampicillin sulbactam 3 gram vials on back order and the company estimates

a release date of mid-October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=159 Dorzolamide 2% and Timolol 0.5% Ophthalmic Solution October 3, 2018 Reason for the Shortage

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 dorzolamide 2% and timolol 0.5% ophthalmic solution in 10 mL bottles 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 early-October 2018.

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 early- to mid-October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=360 Fluphenazine Tablets October 3, 2018 Reason for the Shortage

Lannett did not provide a reason for the shortage.



Lannett has fluphenazine 1 mg tablets on back order and the company estimates a release date

of late-October 2018.

Mylan has fluphenazine 1 mg tablets in 100 count and 500 count, 2.5 mg tablets in 100 count

and 500 count, and 5 mg tablets in 100 count and 500 count bottles on back order and the

company estimates a release date of mid-February 2019.



https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=478 Furosemide Tablets October 3, 2018 Reason for the Shortage

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 40 mg tablets in 100 count bottles on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=339 Lorazepam Injection October 3, 2018 Reason for the Shortage

Bedford discontinued lorazepam injection in May, 2011.

Hikma has product on shortage due to manufacturing delays.

Pfizer has product on shortage due to increased demand and manufacturing delays. Pfizer

discontinued 4 mg/mL 10 mL vials in December 2017.

Akorn has not provided a reason for the shortage.

Amphastar has product available.


Hikma has lorazepam 4 mg/mL 10 mL vials on back order and the company estimates a release

date of October to November 2018.

Hikma has Ativan 2 mg/mL 10 mL vials on back order and the company estimates a release date

of October to November 2018. Ativan 4 mg/mL 10 mL vials are on back order and the company

estimates a release date of October 2018.

Pfizer has lorazepam 2 mg/mL 1 mL Carpuject syringes on back order and the company

estimates a release date of November 2018. The 2 mg/mL 10 mL vials are on back order and the

company estimates a release date of December 2018. The 4 mg/mL 1 mL Carpuject syringes are

on back order and the company estimates a release date of 2019.




Mafenide Acetate Powder for Solution October 3, 2018 Reason for the Shortage


Par did not provide a reason for the shortage.

Mafenide acetate cream is not affected by this shortage.


Mylan has Sulfamylon 50 gram packets on back order and the company estimates a release date

of late-October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=461 Methotrexate Injection October 3, 2018 Reason for the Shortage

Accord did not provide a reason for the shortage.[1]

Fresenius Kabi has methotrexate injection available.[2]

Mylan Institutional did not provide a reason for the shortage. Mylan Institutional discontinued

the 40 mg/mL 2 mL, 4 mL, and 8 mL vials in late-2017.[3]

Pfizer has methotrexate injection available.[4]

Teva has methotrexate injection on shortage due to increased demand.[5]

Hikma has methotrexate injection available.[6]


Teva has methotrexate 25 mg/mL 40 mL preservative-free vials on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=282 Cefpodoxime Oral Suspension October 2, 2018 Reason for the Shortage

Aurobindo has discontinued cefpodoxime oral suspension.

Sandoz has discontinued cefpodoxime oral suspension.

Sun Pharma has discontinued cefpodoxime oral suspension.

Northstar only provides product to McKesson customers.

Rising has product available.


All marketed presentations are available.




Diclofenac 0.1% Ophthalmic Solution October 2, 2018 Reason for the Shortage


Rising pharmaceuticals discontinued diclofenac ophthalmic solution.



Akorn has diclofenac 0.1% ophthalmic solution on long-term back order and the company

cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=395 Meropenem Injection October 2, 2018 Reason for the Shortage

Amneal did not provide a reason for the shortage.


Pfizer has meropenem injection on shortage due to manufacturing delays.

Sagent has suspended manufacturing meropenem at this time.


Amneal has meropenem 500 mg vials on back order and the company cannot estimate a release

date. The 1 gram vials are available in limited supply.

AuroMedics has meropenem 500 mg and 1 gram vials on intermittent back order and the

company is releasing product as it becomes available.

BBraun has meropenem 500 mg/50 mL and 1 gram/50 mL premixes on allocation.

Pfizer has Merrem 500 mg vials (NDC 00310-0325-20) on back order and the company cannot

estimate a release date. Merrem 1 gram vials (NDC 00310-0321-30) are on back order and the

company estimates a release date of October 2018. Pfizer has generic meropenem 500 mg and

1 gram vials on back order and the company estimates a release date of 2019.

Sagent has meropenem 500 mg vials and 1 gram vials on back order and the company cannot

estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=475 Nelarabine Injection October 2, 2018 Reason for the Shortage

Novartis did not provide a reason for the shortage




Novartis has Arranon 5 mg/mL 50 mL vials in 1 count and 6 count on back order with an

expected release date of mid-October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=458 Penicillin G Procaine Injection October 2, 2018 Reason for the Shortage

Pfizer has penicilliin G procaine on shortage due to manufacturing delays.

Pfizer is the sole supplier of penicillin G procaine.


Pfizer has penicillin G procaine 600,000 unit/mL 1 mL and 2 mL syringes on back order and the

company estimates a release date of November 2018 for the 1 mL syringes and October 2018

for the 2 mL syringes.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=240 Ranitidine Injection October 2, 2018 Reason for the Shortage

Teligent has Zantac IV on shortage due to production delays.

Zydus has ranitidine injection available.


Teligent has Zantac 25 mg/mL 2 mL and 40 mL (NDC 52565-0096-01) vials on back order and the

company estimates a release date of 1st quarter 2019. Zantac 25 mg/mL 6 mL and 40 mL vials

(NDC 24987-0364-01) are available but short-dated with an expiration date of November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=426 Thrombin Topical Solution (Bovine) October 2, 2018 Reason for the Shortage

Pfizer has Thrombin-JMI on shortage due to manufacturing delays.

Recombinant thrombin is not affected by this shortage.


Pfizer has Thrombin-JMI 5000 unit vials and 20,000 unit vials on back order and the company

estimates a release date of October 2018. The 5000 unit epistaxis kit, 5000 unit spray kit, 20,000

unit pump spray kit, and 20,000 unit syringe spray kit are available in limited supply.



0.9% Sodium Chloride 10 mL, 20 mL, and 50 mL Preservative Free Vials and Syringes October 1, 2018 Reason for the Shortage


Pfizer has 0.9% sodium chloride preservative-free vials on shortage due to manufacturing

delays.


Fresenius Kabi has 0.9% sodium chloride preservative free 20 mL vials on back order and the

company estimates a release date of mid- to late-November 2018.

Pfizer has 0.9% sodium chloride preservative free 20 mL vials available in limited supply. The 50

mL vials are on back order and the company estimates a release date of October 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=332 Fluorouracil Injection October 1, 2018 Reason for the Shortage

Accord did not provide a reason for the shortage.


Sagent had fluorouracil injection on shortage due to manufacturing delays.

Teva had fluorouracil injection on allocation due to increased demand.


Accord has fluorouracil 50 mg/mL 100 mL vials on intermittent back order and the company is

releasing product as it becomes available.

Fresenius Kabi has fluorouracil 50 mg/mL 100 mL vials on back order and the company estimates

a release date of late-October to early-November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=401 Granisetron Hydrochloride Injection October 1, 2018 Reason for the Shortage





Akorn has granisetron 1 mg/mL 1 mL and 4 mL vials on back order and the company cannot

estimate a release date.




Metoprolol Injection October 1, 2018 Reason for the Shortage

Alvogen has metoprolol injection available.

American Regent has had metoprolol injection on long-term back order for several years.

Athenex has metoprolol injection available.


Fresenius Kabi has metoprolol injection on shortage due to increased demand.

Mylan Institutional acquired metoprolol injection from Sagent. They discontinued metoprolol

injection in March 2018.

Pfizer has metoprolol injection on shortage due to manufacturing delays.



Baxter (formerly Claris) has metoprolol 1 mg/mL 5 mL vials on back order and the company

cannot estimate a release date.

Pfizer has metoprolol 1 mg/mL 5 mL ampules and 1 mg/mL 5 mL Carpuject syringes on back

order and the company estimates a release date of 2019. The 1 mg/mL 5 mL vials are available

in limited supply.

Hikma has metoprolol 1 mg/mL 5 mL vials on allocation. The 1 mg/mL 10 mL vials are on back

order and the company estimates a release date of October 2018.

Nitrofurantoin Oral Suspension October 1, 2018 Reason for the Shortage

Amneal has nitrofurantoin oral suspension available.

Casper Pharma did not provide a reason for the Furadantin shortage.

Lupin is no longer manufacturing this product.

Nostrum relaunched nitrofurantoin oral suspension.

Teva did not provide a reason for the shortage.


Amneal has nitrofurantoin oral suspension on back order and the company cannot estimate a

release date.

Teva has nitrofurantoin oral suspension on back order and the company cannot estimate a

release date.




50% Dextrose Injection September 28, 2018 Reason for the Shortage

Amphastar has 50% dextrose injection available.

Pfizer has 50% dextrose injection on shortage due to manufacturing delays


Pfizer has 50% dextrose 50 mL LifeShield syringes and 50 mL Ansyr syringes on back order and

the company estimates a release date of October 2018. The 50% dextrose 50 mL vials are

available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=306 Aminocaproic Acid Injection September 28, 2018 Reason for the Shortage

Pfizer had aminocaproic acid on shortage due to manufacturing delays.


Pfizer has aminocaproic acid 250 mg/mL 20 mL vials available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=346 Aminophylline Injection September 28, 2018 Reason for the Shortage

Pfizer has aminophylline injection on shortage due to manufacturing delays


Pfizer has aminophylline 25 mg/mL 10 mL vials available in limited supply. The 20 mL vials are on

back order and the company estimates a release date of December 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=407 Dalbavancin Injection September 28, 2018 Reason for the Shortage

Allergan did not provide a reason for the shortage. Allergan is the sole supplier of dalbavancin.


Allergan has Dalvance on back order and the company estimates a release date of mid-October

2018.




Deferoxamine Injection September 28, 2018 Reason for the Shortage

Fresenius Kabi has deferoxamine on shortage due to increased demand.

Pfizer has deferoxamine on shortage due to manufacturing delays.

Novartis has Desferal on shortage due to increased demand.

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 2019. The 2 gram vials are available in limited supply.

Novartis has Desferal 500 mg vials on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=393 Dexmedetomidine Hydrochloride Injection September 28, 2018 Reason for the Shortage


Athenex has dexmedetomidine vials available.

Fresenius Kabi has dexmedetomidine vials available.

Mylan has dexmedetomidine vials available.

Par has dexmedetomidine vials available.

Pfizer did not provide a reason for the shortage.

Sandoz has dexmedetomidine vials available.

Teva has dexmedetomidine vials available.



Hikma has 100 mcg/mL 2 mL vials on allocation.

Pfizer has Precedex 4 mcg/mL 50 mL and 100 mL premixed bottles on back order and the

company estimates a release date of November 2018 for the 50 mL bottles and October 2018

for the 100 mL bottles. The 4 mcg/mL 20 mL vials are also on back order and the company

estimates a release date of October 2018.




Dopamine Hydrochloride Injection September 28, 2018 Reason for the Shortage

American Regent is not marketing dopamine injection.

Baxter had dopamine on shortage due to manufacturing delays.

Pfizer states the shortage is due to manufacturing delays. The dopamine 200 mg/250 mL and

400 mg/500 mL premixed bags were discontinued in August 2017.


Pfizer has dopamine 40 mg/mL 10 mL vials on back order and the company estimates a release

date of 2019. The 400 mg/250 mL bags are on back order and the company estimates a release

date of October 2018. The 800 mg/500 mL bags are available in limited supply. The 40 mg/mL 5

mL vials are on back order and the company estimates a release date of November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=246 Epinephrine Injection September 28, 2018 Reason for the Shortage

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 October 2018.[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.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=313 Labetalol Injection September 28, 2018 Reason for the Shortage

Akorn has labetalol injection available.[1]

Alvogen has labetalol injection available.[2]

Pfizer has labetalol injection on shortage due to manufacturing delays.[3]

Hikma has labetalol injection available.[4]




Hikma has labetalol 5 mg/mL 40 mL vials available with an expiration date of May 2019. The 20

mL vials are on back order and the company estimates a release date of early- to mid-October

2018.

Pfizer has labetalol 5 mg/mL 4 mL syringes available in limited supply. The 20 mL and 40 mL vials

are on back order and the company estimates a release date of August 2019 for the 20 mL vials

and November 2018 for the 40 mL vials.[3]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=286 Methylphenidate Extended-Release Oral Suspension and Chewable Tablets September 28, 2018 Reason for the Shortage

Pfizer has Quillivant XR on shortage due to manufacturing delays.

Pfizer has QuillChew ER chewable tablets available.


Pfizer has Quillivant XR 5 mg/mL extended-release oral suspension in 60 mL bottles,120 mL

bottles, 150 mL bottles, and 180 mL bottles on back order and the company cannot estimate a

release date. There is limited supply of short-dated 180 mL bottles with an expiration date of

March 2019.

Pfizer has QuilliChews 30 mg chewable tablets on back order and the company cannot estimate

a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=373 Potassium Acetate Injection September 28, 2018 Reason for the Shortage

American Regent has not had product available for several years. It is unclear if they will market

potassium acetate again in the future.

Pfizer has potassium acetate on shortage due to manufacturing delays.


Pfizer has potassium acetate 2 mEq/mL 20 mL and 50 mL vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=344 Valsartan Tablets September 28, 2018 Reason for the Shortage

Several drug products containing valsartan were recalled due to an unexpected impurity found

in the active pharmaceutical ingredient manufactured by a third party. The impurity is N-

nitrosodimethylamine (NDMA) and is classified as a probably human carcinogen. Additional



information is available at

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm.

Camber, Major, Solco, and Teva valsartan tablets were affected by the recall. Detailed

information on the products is available at

https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf.

Major, Solco, and Teva discontinued valsartan tablets in July 2018.

Alembic, Aurobindo, Cadista, Lupin, Mylan, Macleods, and Novartis are not affected by this

recall.

Repackagers may have some presentations affected depending on the source supplier.


Aurobindo has valsartan 80 mg tablets on back order and the company cannot estimate a

release date. The 40 mg, 160 mg, and 320 mg tablets are on allocation.

Camber has valsartan tablets on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=444 Cyclosporine Capsules September 27, 2018 Reason for the Shortage


Sandoz has discontinued cyclosporine (modified) capsules.


Apotex has cyclosporine 25 mg and 100 mg capsules on back order and the company estimates

a release date of late-November 2018.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=476 Penicillamine September 27, 2018 Reason for the Shortage


Bausch Health did not provide a reason for the shortage


Mylan has Depen tablets on back order and the company estimates a release date in mid-March

2019.

Bausch Health has Cuprimine capsules on allocation.




14.6% Sodium Chloride Concentrated Solution for Injection September 26, 2018 Reason for the Shortage

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 cannot estimate a release date.

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.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=416 Mitoxantrone Hydrochloride Injection September 26, 2018 Reason for the Shortage

Fresenius Kabi has mitoxantrone available.[1]

Pfizer has 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 mitoxantrone 2 mg/mL 12.5 mL vials available with an expiration date of < 6

months.[1]

Pfizer has mitoxantrone 2 mg/mL 10 mL vials on back order and the company estimates a

release date of March 2019.[2]

Teva has temporarily discontinued mitoxantrone 10 mL vials and the company cannot estimate

a release date.[3]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=189 Isocarboxazid Tablets September 25, 2018 Reason for the Shortage

Validus has Marplan tablets on shortage due to manufacturing delays.


Validus has Marplan on back order and the company cannot estimate a release date.




Bacteriostatic 0.9% Sodium Chloride Vials September 24, 2018 Reason for the Shortage


Pfizer has bacteriostatic sodium chloride vials on shortage due to manufacturing delays.


Pfizer has bacteriostatic 0.9% sodium chloride 10 mL, 20 mL, and 30 mL vials on back order and

the company estimates a release date of December 2018 for the 10 mL vials and October 2018

for the 20 mL and 30 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=441 Dobutamine Injection September 24, 2018 Reason for the Shortage

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 2019. The 12.5 mg/mL 20 mL regular vials in 1 count are on back order

and the company estimates a release date of October 2018. The 12.5 mg/mL 20 mL regular vials

in 10 count are available in limited supply.

Pfizer has dobutamine 1 mg/mL in 250 mL bags on back order and the company estimates a

release date of November 2018. The dobutamine 2 mg/mL 250 mL bags are on back order and

the company estimates a release date of November 2018. The dobutamine 4 mg/mL 250 mL

bags are on back order and the company estimates a release date of November 2018.


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