Drug recall

A drug recall is an action taken to remove a prescription or over-the-counter drug from the market.

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Many countries have a government agency responsible for overseeing the safety and efficacy of pharmaceutical drugs. In the United States, the Food and Drug Administration (FDA) is responsible for a variety of products, including drugs, medical devices and foods. The FDA provides clinical information about safety issues involving prescription and over-the-counter drugs, biologics, medical devices, and special nutritional products, including dietary supplements. The FDA issues and announces recalls, safety alerts, withdrawals, and important labeling changes that may impact the health of consumers.

Drug recalls are often categorized by class.

• A Class I recall occurs where a reasonable probability that the use of or exposure to a product will cause serious injury or death.
• A Class II recall occurs where use or exposure to a product may cause temporary or medically reversible injury.
• A Class III recall are for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations.
• A safety alert is a notice or warning issued in situations where a product may present an unreasonable risk of substantial harm.

The FDA expects drug makers to take responsibility for product recalls, including follow-up checks. When a product is discovered to pose a safety risk or defect, drug makers or distributors will often carry out recalls voluntarily. In other instances, the FDA may inform a company of findings that one of its products is defective and suggest or request a recall. If the firm refuses to recall the product, the FDA may seek legal action under the Federal Food, Drug, and Cosmetic Act. Such legal action may include seizure of available product, and/or injunction of the company, including a court request for recall of the product.

The recall of a defective or harmful drug is sometimes publicized in the media. Often the drug maker will issue its own press release. The FDA publicizes a recall only when it believes the public needs to be alerted about a serious hazard.

After a recall is completed, the FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective.

Tens of millions of consumers have taken at least one of several drugs withdrawn from the market. Highly publicized examples of drug recalls are the withdrawal of the diet drug combination popularly known as fen-phen, the cholesterol drug Baycol, the diabetes drug Rezulin, and the pain drug Vioxx.

External links

• U.S. Food & Drug administration (FDA)
• Center For Drug Evaluation & Research (CDER)
• National Patient Safety Agency (UK)
• Therapeutic Goods Administration (AUS)