PRODUCT RECALL

Republic of the PhilippinesDepartment of Health

Food and Drug Administration

Republic of the PhilippinesDepartment of Health

Food and Drug Administration

What is PRODUCT RECALL?

A recall is when a product is removed from the market…

because it is either defective or

potentially harmful.  – US FDAPermanent removal of therapeutic

goods from supply or use for reasons relating to deficiencies in the quality, safety or efficacy of goods. – Therapeutic Goods Administration, Australia

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There should be a system to recall from the market, promptly and effectively, products known or suspected to be defective. – WHOIn order to protect public health… necessary to implement urgent measures

such as the recall of one or more defective batch(es) of a medicinal

product from the market. – European Medicines Agency (EMA)

Republic of the PhilippinesDepartment of Health

Food and Drug Administration

BUREAU CIRCULAR

NO. 8, S. 2001

Guidelines to be Observed on the Implementation of Product Recall System

B.C. No. 8, s. 2001

Actions taken to remove a product from the market

Initiated by FDA or voluntarily done by company

B.C. No. 8, s. 2001

Encompasses also labeling and/or promotional literature Misbranded products still in violation of the law

are included

Health risks evaluated by a Product Recall Committee

HEALTH HAZARD EVALUATION

Factors to be considered:• Assessment of the likelihood of

occurrence of the hazard

• Assessment of the consequences of occurrence of hazard

HEALTH HAZARD EVALUATION

Factors to be considered:• Assessment of the degree of seriousness of the health hazard

• Whether any disease or injury has already occurred

HEALTH HAZARD EVALUATION

Factors to be considered:• Whether any existing condition(s) could contribute to a clinical situation that could expose human or animal health hazard

• Presents risk of gross deception to the public

RECALL CLASSIFICATION

Class 1 Recall

Situation in which there is a reasonable probability that the use or exposure to the product will cause serious adverse health consequences or death

RECALL CLASSIFICATION

Class 2 Recall

Situation in which use or exposure to the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

RECALL CLASSIFICATION

Class 3 Recall

Situation in which use or exposure to the product is not likely to cause adverse health consequences

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WHO WILL INITIATE

THE RECALL?

A. FIRM INITIATED RECALL

Informs FDA of the voluntary recall

The Marketing Authorization Holder (MAH) is required to communicate with its consignees and inform them of the intended product/s for recall

A. FIRM INITIATED RECALL

You must know the ff.:1. Identity of the product

Generic Name, Brand Name Dosage Form and Strength Registration No. Batch or Lot No. Date of Manufacture and Expiration

2. Reason for the removal

B. FDA ORDERED RECALL

The Director General of the FDA may order a firm to initiate a recall upon the recommendation of Product Recall Committee when the following determinations has been made:

Distributed product presents a safety risk of illness or injury or gross consumer deception

B. FDA ORDERED RECALL

A firm has not initiated a recall of the product

An agency action is necessary or advisable to protect the public health and welfare

FDA ORDERED RECALL Firm shall be notified to order a recall, and of the need to begin immediately a recall of the product

Notification will specify the ff.: Violation Health Hazard classification (Class I, II, or

III) Recall strategy Any other instructions appropriate

GENERAL PROCEDURE FOR PRODUCT RECALL

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MAH •Notify FDA of a product recall•State the full detail of the reason for conducting the recall (e.g. reason, batch/es impacted, circumstances, etc.)

PRC •Receipt of case report/communication from Marketing Authorization Holder (MAH)•Assess the health hazard•Submit a written recommendation to the Director General for the issuance of recall order•Public Health Alert will be issued within 24 hours for cases that have been determined as Class I or Class II Recall

GENERAL PROCEDURE FOR PRODUCT RECALL

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RFO •In-depth inspection of responsible establishment/production facilities where the violation occurred•Refer action done back to Product Recall Committee (PRC)

RFO or Legal or PRC

•In case the firm refuses to conduct the recall, regulatory action will be pursued•Upon determination that the recall process has been completed, a written notification of acknowledged completion will be given to the recalling firm

RECALL STRATEGY

The following elements shall be included in a recall strategy:

1. Depth of Recall (distributor level, retailer level)

2. Effectiveness Checks

In developing a recall strategy, the duration to complete the recall operation should be considered.

RECALL STRATEGY

Duration of recall operation: Class I Recall – Seven (7) days

Class II Recall – Fifteen (15) days

Class III Recall – Thirty (30) days

RECALL STRATEGY

Duration of recall operation: Class I Recall – Seven (7) days

Class II Recall – Fifteen (15) days

Class III Recall – Thirty (30) days

PROPOSAL

Class I Fourteen (14) daysClass II Twenty (20) daysClass III Thirty (30) days

PUBLIC HEALTH ALERT

Issued within twenty-four (24) hours after the duly signed PRO is received by the representative of the MAH

Purpose of alerting concerned populations to serious health hazards

PUBLIC HEALTH ALERTHOW TO VIEW ADVISORIES?

UPDATED LIST OF ADVISORIES FOR DRUG PRODUCTS AS OF 24

JUNE 2015

UPDATED LIST OF ADVISORIES FOR DRUG PRODUCTS AS OF 24

JUNE 2015

• Product Information– Generic name and/or Brand name– Dosage form– Dosage strength– Registration No.

• Batch No. or Lot No. specified• Importer or Distributor• Manufacturer

SALIENT POINTS TO LOOK FOR IN ADVISORIES

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WHAT TO CHECK IN

ADVISORIES?

Product Information?Generic name Brand nameDosage formDosage strengthRegistration No.Batch No. or Lot No.?Importer or Distributor?Manufacturer?

Product Information?Generic name Brand nameDosage formDosage strengthRegistration No.Batch No. or Lot No.?Importer or Distributor?Manufacturer?

Product Information?Generic name Brand nameDosage formDosage strengthRegistration No.Batch No. or Lot No.?Importer or Distributor?Manufacturer?

Product Information?Generic name Brand nameDosage formDosage strengthRegistration No.Batch No. or Lot No.?Importer or Distributor?Manufacturer?

Principal Product ?e.g. DRP-282

Identical Product?e.g. DRP-282-02

For more information: Refer toAdministrative

Order No. 2005-0031FDA Circular No.

2015-001

TERMINATION OF PRODUCT

RECALL ORDER

Seizure, multiple seizures or other court action shall be undertaken by FDA

REFUSAL OR FAILURE OF FIRM

TO CONDUCT PRODUCT RECALL

DISPOSITION OF RECALLED PRODUCTS

MAH will coordinate with FDA

If the products are to be destroyed, the destruction should be witnessed by a FDA representative

• Proactive cooperation with the distributor or MAH… Follow-up at all times

• Routine checking of advisories from the FDA website

• Upon seeing the advisory, the stocks of the drug product meant for recall must be removed from the selling area within 24 hours and stored in a secured area

WHAT IS REQUIRED FROM YOUR END?

• Must observe the recall duration:► Return immediately the stocks of recalled

product/s to the distributor► Proper documents must show the actual

quantity returned

• Product recalls must be treated ALWAYS AS URGENT!

WHAT IS REQUIRED FROM YOUR END?

“Drug safety is everybody’s

concern”

THANK YOU