FDAAugust 9, 2019drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Failed Dissolution Specifications

What to do

FDA enforcement status: Terminated

Brands named

american health packagingamericanamerican health

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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