What Is the FDA's Process for Recalling a Dangerous Drug?

We believe the medications we select from store shelves or receive over the pharmacy counter are safe to use, as we should. While the U.S. Food and Drug Administration (FDA) reviews and approves many medications for consumers’ use, dangerous and defective drugs sometimes slip through the cracks and into consumers’ hands. Learn the process by which the FDA removes dangerous drugs once it has already reached store shelves.

How Does the FDA Recall Medication?

According to the FDA, a drug recall is the most effective way to protect the public from potentially harmful medications. Technically, a recall is a request made by the FDA to the drug’s manufacturer. The FDA’s role in the recall process is to oversee the manufacturer’s strategy, assess the adequacy of the recall, and classify the recall.

The three classifications of recalls include the following:

  • Class I: A dangerous or defective product that could cause serious health problems or death.
  • Class II: A product that might cause a temporary health problem, or pose a slight threat of a serious nature.
  • Class III: A product that is unlikely to cause any adverse health reaction, but that violates FDA labeling or manufacturing laws.

Many of us have heard about recalls involving products or medications. However, not all recalls are announced by the FDA or in the news. Typically, the public is only notified when the recalled product has been widely distributed or poses a serious health hazard.

Harmed by a Dangerous Drug? We’re Here to Help

There have been several drugs identified as dangerous in recent years, including Accutane, Valsartan, Zantac, and more. If you or someone you love has been harmed by a dangerous or defective drug, our Sacramento personal injury attorneys are here to help. Kershaw Talley Barlow has been behind major state and federal cases to help patients find justice and win compensation after being injured by a product they expected to treat them. Learn how we may help you, too.

Call Kershaw Talley Barlow at (916) 520-6639 to schedule a free consultation.

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