Drug product
Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-00 for box; 70518-2489-01 per unit dose.
D-1387-2020
Product summary
- Event
- Event 86006
- Status
- Terminated
- Classification
- Class II
- Quantity
- 498 tablets
- Official record key
drug-enforcement:D-1387-2020
Official wording
Reason: FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
Code information: Lot #: B0796217-020920, Exp. Date: 02/28/2021
Distribution pattern: Product was distributed to MN.
Derived failure modes
-
Potency or specification failure
out-of-specification