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What are the Three Classifications of FDA Recalls for Pharmaceuticals?

March 31, 2017 |

Malamut & Associates - FDA RecallsWe are all familiar with product recalls. They are what happens when a manufacturer or distributor discovers that their product has a safety issue or defect that could potentially cause illness or injury. Though there is no doubt that recalls are issued to protect consumers, they are also designed to protect a company’s reputation and avoid being found legally liable for any injuries.

Recalls can be issued for all types of products, ranging from automobiles to food products, and the details of a recall may include an offer to refund the purchase price, replace the product with a safer version, or provide repairs to the defect that was discovered. When it comes to medications, drug recalls generally pull the product off the market entirely. When this happens, those who have been injured by the medication are advised to contact drug recall lawyers to learn about their eligibility to pursue litigation seeking compensation for the damages that they have suffered. Pharmaceutical companies are subject to U.S. Food and Drug Administration supervision, which imposes three classifications of Food and Drug Administration (FDA) recalls on their industry.

The three classifications of FDA recalls for pharmaceuticals are labelled Class I, Class II and Class III. The details of each are as follows:

  • Class I – These recalls are the most serious category. They occur when there is a reasonable chance that using or being exposed to the drug will cause serious adverse health consequences or death.
  • Class II – These recalls occur when using or being exposed to the drug might cause an adverse health consequence that is either temporary or medically reversible. This class of recall also applies when the chance of a serious health consequence is remote.
  • Class III – These recalls are the least serious category. They occur when a recall is imposed even though using or being exposed to the drug has little or no likelihood of causing an adverse health consequence.

Drug companies have a few other options beyond a product recall when they are facing issues with their products. For example, a drug manufacturer that learns that their product has been tampered with can issue a market withdrawal to correct the problem or prevent injury, even though the problem is not subject to legal action on the part of the FDA. A pharmaceutical company can also issue a medical device safety alert when there is evidence of unreasonable risk from its use.

Not every recall is issued under orders of the FDA. In many cases a company can initiate a recall on its own. The FDA can also request a recall without taking statutory action imposing it.

Over the years there have been several drugs that have been recalled for a variety of reasons. These include the acne medication Accutane, which was recalled due to increased risk of birth defects and the opioid pain reliever Darvon, which caused serious cardiac toxicity. If you or someone you love has been injured because of a recalled drug, the drug recall lawyers at Malamut & Associates can help.