D-1331-2020 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) 92,793 bottles and b) 4,824 bottles
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
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) 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