ARTICLE:-- Drug Recalls Details by FDA

Drug Recalls Details by FDA

Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. See Definitions of Market Withdrawals and Class I, II, and III recalls. All recalls (Class I, II, and III) can be found in the FDA Enforcement Report.

In July 2011, FDA began a pilot program to notify people of drug recalls before they are classified. These unclassified recalls will be published in the Enforcement Report every Wednesday, and will be listed under the heading, “Human Drug Product Recalls Pending Classification.” They will be reposted with their classification once that determination has been made.

Background and Definitions

Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.

• Class I recall: 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 or death.
• Class II recall: 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 recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
• Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
• Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.