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Products Liability Blog Post

How Does an FDA Drug Recall Work?

The U.S. Food and Drug Administration (FDA) approved your medication, so it is safe, right? Many people believe this to be true. Unfortunately, FDA approval does not always mean a drug is safe.

The FDA approval process allows pharmaceuticals to enter the market based upon studies conducted by the drug manufacturers. Research and development on any given drug can cost many millions of dollars and take years to complete. If the FDA rejects the medication, the money and time does not translate into profits for the company. For this reason, pharmaceutical manufacturers have an incentive to conduct the bare minimum testing and to push the medicine through the FDA approval process.

Often safety concerns are not discovered until the drug is already on the market. Typically, the problems do not come to light until patients are injured, or in the worst cases, die. Even after multiple patient injuries, the U.S. government does not normally issue a recall. Instead, the company recalls the product voluntarily.

The recall is classified according to the severity of the potential injuries:

  • Class I — Reasonable likelihood that the drug may cause a serious adverse health consequence or fatality.
  • Class II — The medication may cause an adverse health consequence that is temporary or medically reversible, or the likelihood that a serious adverse health consequence might occur is possible, but remote.
  • Class III — The defective pharmaceutical is not likely to result in adverse health consequences.

Patients can view the FDA’s website for up-to-date drug recall data, including:

  • Date of recall
  • Brand name of the drug or supplement
  • Description of the product
  • Problem detected in the product
  • Manufacturer
  • Press release and label photos

If a drug you are taking is recalled, contact your doctor immediately to learn what you need to do to protect your health. Regardless of whether the drug is subject to recall, consult with a San California pharmaceuticals liability lawyer if you suffered harm from a defective or contaminated medication.

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Thorsnes Bartolotta McGuire
2550 Fifth Avenue, 11th Floor
San Diego, California, 92103-6612 USA