FDAFDA · Food and drugs·Recall number D-1332-2020
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
Published July 1, 2020 · Recall initiated: June 2, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Product was distributed throughout the United States, including Puerto Rico.
- Lot
- a) 1333338M, exp. date 08/2020, 1333339A, exp. date 08/2020; b) 1354471A, exp. date 02/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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