D-0675-2025 Class II Ongoing
FDA drug recall D-0675-2025 was initiated by Amerisource Health Services LLC on September 15, 2025 and is designated Class II. Reason for recall: Failed Dissolution Specifications. The recall status is ongoing. Affected quantity: 360 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- October 8, 2025
- Initiation Date
- September 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 360 cartons
Product Description
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)
Reason for Recall
Failed Dissolution Specifications.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: 1024078, Exp. Date 08/31/2026