PRODUCT RECALL

There are three type and class of recalls 

Class I : defined as a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences of death; 

Class II : defined as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote; 

class III : defined as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 

Communication:  Communication must effectively remove violative product by giving proper notice to recipients of such products. 

Recall effectiveness monitoring:  The FDA monitors recall effectiveness by follow-up inspection or audit checks or makes recommendations if it finds the recall is ineffective

Strategy:  Each recall is different and requires a different strategy to resolve the problem. 

Public Notification:  The firm has the responsibility to notify the public of the recall, and the FDA does so via the weekly  Enforcement Report. Once a recall has been placed in a weekly  Enforcement Report, the FDA decides when it will be removed.

Status Reports:  Recall Status Reports must be provided periodically to update the FDA on the progress of the recall. 

Termination:  Termination of a recall is determined by the FDARegulated product withdrawal:  Regulated product withdrawals result in complete removal of the product from the market and it will not be available in the future. J. 

Recall facts:  Recalls occur because products are adulterated or misbranded.  The problems with products can occur due to manufacturing/testing method deficiencies, contamination, inconsistent potency, labeling or packaging mix-ups, other product specification problems, dissolution, noncompliance with  National Institute on Drug  Abuse (NIDA) monographs, or bioequivalence/abbreviated new drug application (ANDA) discrepancies.

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