Product Recall. How And Why A Product Is Recalled

It is well known that U.S. Food and Drug Administration (FDA) is the oldest consumer protection agency in the U.S. Federal Government and it is responsible for protecting public health in the areas of:

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  • Human and Veterinary Drugs
  • Biological Products
  • Medical Devices
  • Nation’s Food Supply
  • Cosmetics
  • Products that emit radiation

recallProduct recall is defined as removal from the market when the company discovers a problem on their own and decides to recall the product or a product is removed by FDA. A correction can be made to the product due to its defects or potential harm. There can be three Classes of recalls. Class I recalls include products that would cause serious adverse health consequences or death. Class II recalls are applied for those products, which use may cause temporary reversible adverse health consequences. Class III recall is a situation in which a product is not likely to cause adverse health consequences.

fda alert

When a firm removes the product from the market because of minor violation, that would not be subject to FDA legal action  and corrects it, it is called market withdrawal. Sometimes a medical safety alert is considered a recall when it is issued due to unreasonable risk of substantial harm a medical service may present.

If you or a family member has been affected by a harmful product or drug, you should seek a qualified lawyer who specializes in this area. On Legal Bistro you can find the right one!


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