D-1332-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 1, 2020
- Initiation Date
- June 2, 2020
- Termination Date
- April 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 15,329 bottles and b) 137 bottles
Product 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
Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Distribution Pattern
Product was distributed throughout the United States, including Puerto Rico.
Code Information
a) 1333338M, exp. date 08/2020, 1333339A, exp. date 08/2020; b) 1354471A, exp. date 02/2021