Recalls

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Question

Why are there drug recalls?

Answer

The Food and Drug Administration (FDA) recalls drugs as a way to protect the public. When an FDA-regulated product is defective or potentially harmful, it is recalled. FDA-regulated products may include human drugs, animal drugs, medical devices, radiation-emitting products, vaccines, blood blood products, transplantable human tissue, animal feed, cosmetics, and about 80% of the foods eaten in the United States.

Drug recall classes

Class I recalls are the most severe. It would be any dangerous or defective product that could cause serious health problems or death. Some examples include food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.

Class II recalls include products that might cause a temporary health problem or pose only a slight threat of a serious nature. Some examples include a drug that is under-strength but isn't used to treat a life-threatening situation.

Class III recalls include products that are unlikely to cause an adverse health reaction, but violate FDA labeling or manufacturing laws. Some examples include a minor container defect and lack of English labeling in a retail food. Often times the manufacturer does a voluntary recall of their product even if the FDA does not mandate it.

For the latest product and drug recall notices, please visit recalls.gov.

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