Guidances (Drugs) > Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Holding and Distribution

Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Holding and Distribution


Human Drug Recalls

1.What is a recall?
2.Can FDA mandate a recall of human drugs?
3.Are OTC drugs subject to the same recall provisions as prescription drugs?
4.Do manufacturers of OTC products have to report quality defects?
5.Does FDA expect firms to investigate both released and rejected lots for potential recalls?
6.What happens if a firm does not voluntarily recall a defective product?

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Guidances (Drugs) > Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Holding and Distribution