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U.S. Department of Health and Human Services

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What does ‘recall’ mean?

Recall means a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure.  Recall does not include a market withdrawal or a stock recovery.  21 CFR 7 provides guidance so that responsible firms may conduct an effective recall.

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