Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) 1333338M, exp. date 08/2020, 1333339A, exp. date 08/2020; b) 1354471A, exp. date 02/2021
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Teva Pharmaceuticals USA
- Reason for Recall:
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ
Product Codes/Lot Numbers:
a) 1333338M, exp. date 08/2020, 1333339A, exp. date 08/2020; b) 1354471A, exp. date 02/2021
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1332-2020
Related Recalls
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Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
CGMP Deviations: use of an unapproved raw material