If the FDA or a manufacturer finds that a marketed product presents a threat or a potential threat to consumer safety, that product may be recalled or sought for return to the manufacturer from its depth of distribution. The pharmaceutical manufacturer is legally bound to report serious unlabeled adverse reactions to the FDA through the FDA MedWatch Program (800-FDA-1088 or www.FDA.gov).
A practitioner also has a responsibility to report a problem with any drug product or medical device using the MedWatch program. Reported problems may include product defects, product adulteration, container leakage, improper labeling, unexpected adverse reactions, and others.
A drug product recall may be initiated by the FDA or by the manufacturer, the latter being termed a voluntary recall. A numerical classification, as follows, indicates the degree of hazard associated with the product being recalled:
- Class I: There is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
- Class II: The use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or the probability of serious adverse health consequences is remote.
- Class III: The use of or exposure to a violative product is not likely to cause adverse health consequences.
The depth of recall, or the level of market removal or correction (e.g., wholesaler, retailer, consumer), depends on the nature of the product, the urgency of the situation, and depth to which the product has been distributed. The lot numbers of packaging control numbers on the containers or labels of the products help in identifying the product to be recalled.
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