Featured News 2019 What is a Drug Recall?

What is a Drug Recall?

A drug recall refers to when a product is taken off the market or when the product is corrected because it was found defective or potentially dangerous to the consumer. Sometimes a manufacturer discovers the problem on its own and recalls the product, while other times a drug is recalled by U.S. Food and Drug Administration (FDA).

If you have a medication that has been recalled by the manufacturer or the FDA, you want to contact your health care provider immediately and ask them about the best course of action.

In July 2011, the FDA initiated a pilot program which notifies the public about drug recalls before they are classified. These recalls are published every Wednesday in the Enforcement Report, and are listed under the heading, "Human Drug Product Recalls Pending Classification."

The drugs listed in the report will be reposted with their classification once the FDA has made its determination.

How are recalls classified?

According to the FDA, the recalls on the above list are usually Class I, which means that there is a reasonable probability that using or being exposed to the volatile product will either cause serious adverse health consequences, or it can lead to death.

Grouped by severity, the recalls include:

  • Class I – Very dangerous and could cause death.
  • Class II – Using the drug may cause temporary problems, or there is a slight risk that the drug could lead to serious health problems.
  • Class III – Using the drug is not likely to lead to adverse health consequences.

Once a manufacturer initiates a drug recall, it must notify the FDA and follow up to ensure the recall was successful. Conversely, whenever the FDA issues a recall, the drug manufacturer must comply.

If you were injured by a dangerous drug, whether or not it was recalled, you may be able to file a product liability claim against the manufacturer. To learn more about filing a claim for compensation, contact a personal injury attorney.

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