The FDA role in drug recalls

Government agencies in Texas and at the federal level regulate and monitor the safety of drug products. When safety considerations become serious enough such products can be subject to voluntary or mandatory recalls, and in the latter case the Food and Drug Administration can order a prescription drug recall in its own volition. Whether the recall is voluntary or is done at the behest of the FDA, the agency oversees the recall and determines when or whether the defective product is safe to again be offered to the public.

One way that an unsafe product can come to the attention of the FDA is through the Centers for Disease Control and Prevention. When a national health issue comes to the attention of the CDC involving a food, drug or cosmetic product, that information is also brought to the attention of the FDA. The FDA also becomes aware of defective products through notifications from product manufacturers and from inspections conducted by government agency employees.

The FDA classifies food, drug and cosmetics product recalls into three classes. A dangerous product that could result in a consumer death or a consumer injury is a Class I recall. Class II recalls concern defective products that might cause temporary illness or serious injury, and defective Class III recalls issue with regard to products that violate FDA regulations but will probably not cause a consumer injury or illness.

Although a recall of defective products is supposed to protect consumers by removing them from stores and pharmacies, it remains possible that some people can still have them in their possession and still suffer harm as a result. If you have been injured by a dangerous product, you may have a cause of action for compensation in the form of a settlement or money damages. A Texas products liability law firm may be able to help you to determine if you have a products liability case and to take action if you do.