Class II
Completed
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
- Company
- Apotex Inc.
- Recall Initiated
- May 27, 2020
- Posted
- June 24, 2020
- Recall Number
- D-1303-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 305,963 bottles
- Firm Location
- North York, Canada
Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Distribution
Nationwide.
Lot / Code Info
All lots remaining within expiry
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