Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Product description
Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
Lot numbers, UPCs & expiration codes
a) 1329548A, exp. date 06/2020 1338302M, exp. date 10/2020 1348968M, exp. date 10/2020 1348969M, exp. date 10/2020 1348970M, exp. date 11/2020 1376339M,, exp. date 09/2021 b) 1323460M, exp. date 06/2020 1330919M, exp. date 6/2020 1338300A, exp. date 10/2020 1341135M, exp. date 12/2020 1391828M, exp. date 11/2021
Where it was sold
Product was distributed throughout the United States, including Puerto Rico.
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-1331-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 2, 2020
- FDA report date
- Jul 1, 2020
- Quantity
- a) 92,793 bottles and b) 4,824 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1331-2020, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85797
- Address
- 400 Interpace Pkwy
- Code information
- a) 1329548A, exp. date 06/2020 1338302M, exp. date 10/2020 1348968M, exp. date 10/2020 1348969M, exp. date 10/2020 1348970M, exp. date 11/2020 1376339M,, exp. date 09/2021 b) 1323460M, exp. date 06/2020 1330919M, exp. date 6/2020 1338300A, exp. date 10/2020 1341135M, exp. date 12/2020 1391828M, exp. date 11/2021
- Postal code
- 07054-1120
- Report date
- Jul 1, 2020
- Product type
- Drugs
- Recall number
- D-1331-2020
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- a) 92,793 bottles and b) 4,824 bottles
- Termination date
- Apr 12, 2024
- Reason for recall
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
- Distribution pattern
- Product was distributed throughout the United States, including Puerto Rico.
- Recall initiation date
- Jun 2, 2020
- Initial firm notification
- Press Release
- Center classification date
- Jun 19, 2020