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)
Reported: October 8, 2025 Initiated: September 15, 2025 #D-0675-2025
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.
Details
- Recalling Firm
- Amerisource Health Services LLC
- Units Affected
- 360 cartons
- Distribution
- Nationwide in the USA.
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Amerisource Health Services LLC. Units affected: 360 cartons.
Why was this product recalled? ▼
Failed Dissolution Specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 8, 2025. Severity: Moderate. Recall number: D-0675-2025.
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