drug recall
- Guideline or reference source
- FDADST An FDA Guide to Drug Safety Terms
- Definition
- A drug recall is an action taken by a firm to remove a product from the market that FDA considers to be in violation of the law. Recalls are classified as Class I, Class II, or Class III. Class I recalls are the most serious and involve situations where there is a reasonable probability that the use of or exposure to a violative product, will cause serious adverse health consequences or death. A drug may be recalled due to factors such as problems with packaging, manufacturing, or contamination.
- Related Term
- contamination
- product recall
- return
- safety concern
- safety signal
- urgent safety restriction
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