Drug product
Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130, India; Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-268-05
D-1317-2020
Product summary
- Event
- Event 85644
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6228 Bottles
- Official record key
drug-enforcement:D-1317-2020
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: 4FF4F001, Exp 1/2023
Distribution pattern: USA Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications