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Understanding FDA Procedures in a Pharmaceutical Recall


News reports are filled with frequent recalls of harmful and dangerous drugs. Many times, companies voluntarily issue a recall after receiving consumer complaints. However, in other situations the Federal Drug Administration (FDA) may be the one to issue a recall.

The FDA follows a lengthy list of procedures when a recall is warranted. If a product is defective or dangerous, a recall can take it out of the supply chain and can provide methods for consumers to return products and receive refunds.

Summary of FDA procedures in a recall

The FDA has broad powers with respect to recalls. While many recalls are voluntary, the FDA can request a formal recall or it can confiscate a product. The FDA can also seek an injunction against the manufacturer of a harmful product.

Generally, stages of the recall process are:

  • Initiation of the recall. Recalls can be voluntary, requested by the FDA or mandated by the FDA. Most recalls are voluntary.
  • Classification and strategy. In general there are three types of recalls. In this phase of the process, the FDA reviews information including the strategy provided by the company to deal with the recall.
  • Notification and public warning. The FDA informs the company of the classification as well as any changes needed in the recall. FDA recalls are posted on the FDA Internet site
  • Monitoring and auditing. The FDA keeps track to ensure the recall is effective.
  • Termination of the recall. The FDA terminates the recall at the appropriate time.

If you are injured by any type of drug or product, you may be able to file a product liability lawsuit. Contact us today.