Recalls / Class II
Class IID-1360-2020
Product
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904-5794-61
- Affected lot / code info
- Lot T-02134, exp 09/2020
Why it was recalled
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Recalling firm
- Firm
- The Harvard Drug Group
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17177 N Laurel Park Dr Ste 233, N/A, Livonia, Michigan 48152-3951
Distribution
- Quantity
- 1,906 Cartons
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2020-06-12
- FDA classified
- 2020-06-26
- Posted by FDA
- 2020-07-08
- Terminated
- 2022-09-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1360-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.