Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
Product description
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
Lot numbers, UPCs & expiration codes
All lots remaining within expiry
Where it was sold
Nationwide.
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-1303-2020
- Classification
- Class II
- Status
- Completed
- Recall initiated
- May 27, 2020
- FDA report date
- Jun 24, 2020
- Quantity
- 305,963 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-1303-2020, exactly as published.
Show all FDA fields
- City
- North York
- Status
- Completed
- Country
- Canada
- Event ID
- 85772
- Address
- 150 Signet Drive
- Code information
- All lots remaining within expiry
- Report date
- Jun 24, 2020
- Product type
- Drugs
- Recall number
- D-1303-2020
- Classification
- Class II
- Recalling firm
- Apotex Inc.
- Product quantity
- 305,963 bottles
- Reason for recall
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide.
- Recall initiation date
- May 27, 2020
- Initial firm notification
- Press Release
- Center classification date
- Jun 12, 2020