Class II
Terminated
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
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- June 2, 2020
- Posted
- July 1, 2020
- Recall Number
- D-1332-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 15,329 bottles and b) 137 bottles
- Firm Location
- Parsippany, NJ, United States
Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Distribution
Product was distributed throughout the United States, including Puerto Rico.
Lot / Code Info
a) 1333338M, exp. date 08/2020, 1333339A, exp. date 08/2020; b) 1354471A, exp. date 02/2021
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