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What Is a Drug Recall?

drug recall is when patients and consumers are asked to stop using, destroy, or return a drug. Sometimes, the drug in question is the entire supply of a particular drug. This type of drug recall is issued when a drug is determined to be unreasonably dangerous, and the drug is being removed from the market, temporarily or permanently. Other times, only particular lots of a drug are recalled, typically because the drug is contaminated or otherwise violates quality control standards of the Food and Drug Administration (FDA) or the manufacturer. Drug recalls can be either voluntary (sometimes in response to FDA request) or initiated by the FDA.

If you have suffered an injury as a result of a dangerous drug recalled by the FDA or the manufacturer, the pharmaceutical injury litigation lawyers at Schlichter, Bogard & Denton can help you understand your legal options.  Please call or email us today for a free consultation.

Drug Recall Basics

Drug recalls are intended to remove drugs that in one way or another violate the laws administered by the FDA, or new information undermines a drug’s FDA approval. Drug recalls are intended to remove a defective drug from the market, and should not be confused with other FDA actions like market withdrawals, safety alerts, and label alterations like adding a black box warning.  Drug recalls are divided into three classes:

  • Class I Recall means that use of or exposure to the recalled drug will likely cause “serious adverse health consequences or death.”
  • Class II Recall means that the recalled drug may result in a temporary or reversible condition, or has only a small chance of causing serious adverse health consequences
  • Class III Recall means that the recalled drug is not likely to cause any adverse health consequences

In addition to these classes of recall, the FDA also uses what is known as a market withdrawal to remove products that have minor violations, often not the fault of the company. Market withdrawals are commonly used when a drug has been tampered with by someone other than the company.

Voluntary or FDA-Initiated Recalls

Recalls may be initiated by the drug manufacturer on its own initiative, at the FDA’s request, or under an explicit order by the FDA.

If a recall is initiated by the drug manufacturer, the FDA still plays an important role in the design and execution of that recall. The FDA will review and suggest changes to the manufacturer’s recall strategy, including the phrasing in its communications and press releases. The FDA will also classify the recall as Class I, II, or III. The FDA also monitors the recall. The FDA may also respond to the recall with additional action, including legal penalties, inspections, and expansion of the recall to related products.

In urgent situations, the FDA may request a recall. Typically, the FDA will only request a recall when it believes a drug poses a Class I threat, and will normally only request a recall when it has sufficient evidence to suggest additional action, including seizure of applicable lots.

The FDA can also require that a firm recall its products under certain circumstances. Mandatory recalls are not applicable to most drugs, being limited to medical devices, biologics, tissue for human transplantation, infant formula, and milk.

For more information about recalled drugs, please visit our Current Recalls page.

recalled drug may be responsible for serious, permanent injury or death. If you have suffered an injury from a defective or recalled drug, the drug litigation attorneys at Schlichter, Bogard & Denton can help you understand the legal remedies available to you.  Please contact us today for a free initial consultation.

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