Drug product
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)
D-0675-2025
Product summary
- Event
- Event 97634
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 360 cartons
- Official record key
drug-enforcement:D-0675-2025
Official wording
Reason: Failed Dissolution Specifications.
Code information: Lot #: 1024078, Exp. Date 08/31/2026
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications