Why it was recalled
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Product description
Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60
Lot numbers, UPCs & expiration codes
Lot #: 1410946A; Exp. 06/2023
Where it was sold
CA
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-0441-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 22, 2023
- FDA report date
- Mar 15, 2023
- Quantity
- 12,044 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0441-2023, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 91744
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot #: 1410946A; Exp. 06/2023
- Postal code
- 07054-1120
- Report date
- Mar 15, 2023
- Product type
- Drugs
- Recall number
- D-0441-2023
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Product quantity
- 12,044 Bottles
- Termination date
- Dec 6, 2023
- Reason for recall
- CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60
- Distribution pattern
- CA
- Recall initiation date
- Feb 22, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 7, 2023