Recalls / Class II
Class IID-1303-2020
Product
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1
- Affected lot / code info
- All lots remaining within expiry
Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Recalling firm
- Firm
- Apotex Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 150 Signet Drive, North York, N/A, Canada
Distribution
- Quantity
- 305,963 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2020-05-27
- FDA classified
- 2020-06-12
- Posted by FDA
- 2020-06-24
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-1303-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.