Drug product
Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920.
D-0365-2022
Product summary
- Event
- Event 89146
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,336 Bottles
- Official record key
drug-enforcement:D-0365-2022
Official wording
Reason: Failed Dissolution Specifications
Code information: Batch: 4J11G002 Exp. 08/2024
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications