Drug product
Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60
D-0441-2023
Product summary
- Event
- Event 91744
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,044 Bottles
- Official record key
drug-enforcement:D-0441-2023
Official wording
Reason: CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Code information: Lot #: 1410946A; Exp. 06/2023
Distribution pattern: CA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations