Drug recall
Drug recall
Drug recall (/drʌɡ rɪˈkɔːl/) is a process initiated by a pharmaceutical company or a regulatory authority, such as the Food and Drug Administration (FDA) or the European Medicines Agency (EMA), to return a product due to safety issues or defects that might endanger consumers or put the manufacturer at risk of legal action.
Etymology
The term "drug recall" is derived from the English words "drug", which refers to a substance used to treat, cure, or prevent diseases, and "recall", which means to order the return of (a product).
Types of Drug Recalls
There are generally three types of drug recalls:
- Voluntary recall: This is initiated by the pharmaceutical company itself when it discovers a problem with one of its products.
- FDA-requested recall: This occurs when the FDA finds a problem and requests that the pharmaceutical company recall the product.
- FDA-mandated recall: This is rare and only occurs when a pharmaceutical company refuses to recall a product that the FDA has determined is posing an imminent danger to public health.
Related Terms
- Adverse Drug Reaction (ADR): A harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product.
- Pharmacovigilance: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
- Good Manufacturing Practice (GMP): A system for ensuring that products are consistently produced and controlled according to quality standards.
See Also
External links
- Medical encyclopedia article on Drug recall
- Wikipedia's article - Drug recall
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