What is a Drug Recall?

What is a Drug Recall?

A drug recall describes the situation in which a drug is removed from the market due to the discovery of evidence of the high likelihood that the drug has or will cause extremely serious injury or death.

In most cases, the recall is voluntarily conducted by the drug’s manufacturer, due to their awareness that the products are defective or dangerous and due to pressure applied by the F.D.A. (U.S. Food and Drug Administration). If necessary, the FDA can go to court to force the company to issue the recall.

There are 3 different categories of drug recalls issued by the F.D.A.

Category I: The use of, or exposure to, the recalled drug is most likely capable of causing a serious health issue or even death to the consumer.

Category II: The use of, or exposure to, the recalled drug is not likely to cause a serious health issue. At most, it may cause temporary or medically reversible adverse health consequences.

Category III: The use of, or exposure to, the recalled drug is not likely to cause an adverse reaction.

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