product recall overview
TRANSCRIPT
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
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
• 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
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
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?