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The Role of the FDA in Drug Recalls

Mobile, Alabama Injury Lawyers - Long & Waite, PC

While the U.S. Food and Drug Administration does play a significant role in food, drug, and cosmetic recalls, their actual legal power tends to get overestimated. In fact, the FDA does not have the "power" to recall anything unless it is a medical device, human tissue product, or infant formula. So, what exactly is the FDA’s role in product recalls?

Typically, when a product is found to be unsafe or defective, its manufacturer or distributor will recall the product without any government intervention. It is in their best interest to get faulty and potentially dangerous products off the market as soon as possible. If the FDA is the first to discover the faulty product, then they may request a recall by the manufacturer. In most cases, the manufacturer will recall the product voluntarily. If a manufacturer does not recall an unsafe or defective product, then the FDA can make a written request to the manufacturer. If this is not complied with, then the FDA can take legal action.

Manufacturer’s responsibilities during a recall

Manufacturers have to follow certain guidelines and procedures during the recall of a defective product. They are as follows: 1) they must assume full responsibility for the recall process, 2) they must notify the FDA when the recall has begun, 3) they must provide progress reports to the FDA, and 4) they must perform follow-up checks to see that all defective products are taken off the market. After all defective products are returned to the manufacturer, the FDA then makes sure the products are either suitably reconditioned or destroyed.

Recall classes

The extent of FDA involvement in a recall depends largely on the amount of risk the product poses to public health and safety. The classification of defective products is as follows:

  • Class I - Includes defective, or mislabeled products which are likely to cause serious health complications or death upon exposure.
  • Class II - Includes defective, or mislabeled products which are likely to cause temporary or reversible health complications upon exposure.
  • Class III - Health complications are not likely to result from exposure, but the product does not meet FDA manufacturing or labeling regulations.

If you live in the Mobile, Alabama area and have suffered injury or illness due to a defective or mislabeled drug or other defective product, please contact Long & Waite, Attorneys at Law today to arrange a consultation.

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