Why it was recalled
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Product description
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
Lot numbers, UPCs & expiration codes
Lot T-02134, exp 09/2020
Where it was sold
Nationwide USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1360-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 12, 2020
- FDA report date
- Jul 8, 2020
- Quantity
- 1,906 Cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group
Original FDA data
Every field from FDA enforcement report D-1360-2020, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 85861
- Address
- 17177 N Laurel Park Dr Ste 233
- Code information
- Lot T-02134, exp 09/2020
- Postal code
- 48152-3951
- Report date
- Jul 8, 2020
- Product type
- Drugs
- Recall number
- D-1360-2020
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group
- Product quantity
- 1,906 Cartons
- Termination date
- Sep 24, 2022
- Reason for recall
- CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Jun 12, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 26, 2020