Drug Recall

A drug recall may be conducted at a company’s own initiative or by FDA request. The FDA’s role in the recall process includes overseeing the company’s recall strategy, assessing the adequacy of the corrective actions, and classifying the recall. A recall involves removing a defective drug product from the market or warning patients and consumers about potential risks, aiming to protect the public from harm.

• Class 1 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 2 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 3 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.