Drug product
Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-562-21; NDC Unit Dose: 68084-562-11
D-1821-2019
Product summary
- Event
- Event 83559
- Status
- Terminated
- Classification
- Class II
- Quantity
- 457 cartons
- Official record key
drug-enforcement:D-1821-2019
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot 181677, exp 11/30/2020
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications