Drug product
Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking Ridge, NJ 07920; Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC 0904-6172-61
D-0807-2021
Product summary
- Event
- Event 88583
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 Cartons of 100 count each
- Official record key
drug-enforcement:D-0807-2021
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot R01562; Exp. 10/2022
Distribution pattern: NC
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications