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FDA Procedures in a Pharmaceutical Recall

We have all seen the warnings that flash on the screen and are read aloud during television commercials that promote prescription drugs and other pharmaceutical products. In spite of these warnings, the fact remains that drugs are dangerous substances that may result in serious harm to those who ingest them. Sometimes, after years of being on the market, a drug is found to be unsafe. Other times, one or more batches may have been manufactured in a defective manner.

When enough consumers complain about a drug, the manufacturer often issues a voluntary recall. In other cases, the Federal Drug Administration (FDA) may step in and call for a drug to be recalled mandatorily. The recall procedures that the FDA follows are complex.

Summary of FDA procedures in a recall

Taking a drug out of the supply chain is not something that drug companies or the FDA take lightly. The FDA has broad powers to effectuate the removal or correction of defective products.

Generally, the process of a recall is as follows:

  • Initiation of the process — While most recalls are voluntary, they may be requested or mandated by the FDA.
  • Determination of a recall, including strategy and classification — The FDA reviews all information, including the strategy to be used, assesses the health hazard of the product and classifies the recall.
  • Notification and public warning — The FDA notifies the manufacturer of changes needed in the strategy, including the need for a press release and the classification of the recall. The FDA posts recalls on its website.
  • Monitoring and auditing — The FDA implements an audit to ensure effectiveness of the recall.
  • Termination of the recall — At the appropriate time, The FDA sends written notice of the termination of the recall.

If you have the misfortune of having an adverse reaction to a drug, you may be able to seek recourse against the manufacturer in a drug liability lawsuit.  An experienced attorney at Fazio, Disalvo & Abers can examine the facts of your case and advise you of your options for legal action.

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