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Clark Love & Hutson

The Nationally Recognized Plaintiffs Litigation
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The Nationally Recognized Plaintiffs Litigation Law Firm

How does an FDA recall work?

On Behalf of | Jul 13, 2023 | Dangerous Drug Litigation |

The United States Food and Drug Administration, or FDA, is in charge of ensuring that the drugs and medical devices sold in this country are safe.

The FDA has a process for approving the use of drugs and medical devices before they hit the open market. Even so, sometimes the FDA will have to work with drug or medical device companies to recall an unsafe product.

The recall process is involved, but there are a few important points the public should remember.

  • The FDA classifies its recalls. A Class I recall means that the product could cause a serious injury or health problem. By contrast, a Class III recall means that, in the FDA’s opinion, the product defect is not going to hurt anyone.
  • Calling a recall “voluntary” is a bit of a misnomer. Yes, often companies will on their own identify a safety problem, report it to the FDA, and go about it correcting it. But this is part of their legal obligation.
  • On the other hand, a “market withdrawal” does not necessarily mean there was anything wrong with the drug or medical device itself. If a person hears about a market withdrawal, they should not assume that the product was either safe or dangerous. Market withdrawals happen for any number of reasons.
  • Recalling a product could involve repairing the product or fixing the issue, replacing it or offering a refund. Usually, the FDA and manufacturer will work together to develop a plan.
  • The goal of a recall is to make sure that companies follow the FDA’s rules about product safety. Ultimately, the FDA does not want unsafe products available to the public.

Victims injured by a recalled drug or medical device have legal options

However, the recall itself is not a way for victims of dangerous products to receive compensation. In order to receive compensation, a victim will need to understand their legal options. One option is to file an appropriate medical products liability lawsuit against those responsible for their losses.