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
Reported: August 21, 2019 Initiated: August 9, 2019 #D-1821-2019
Product Description
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
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- American Health Packaging
- Units Affected
- 457 cartons
- Distribution
- Nationwide USA
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by American Health Packaging. Units affected: 457 cartons.
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 21, 2019. Severity: Moderate. Recall number: D-1821-2019.
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