Drug product
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01
D-0640-2021
Product summary
- Event
- Event 88033
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21240 bottles
- Official record key
drug-enforcement:D-0640-2021
Official wording
Reason: CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Code information: Lot M915601 & M915602, Oct 2021
Distribution pattern: Nationwide in the US
Derived failure modes
-
Manufacturing or process control
CGMP Deviations