Drug & medication recalls Moderate risk

American Health Packaging recalls Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister cards x 10 unit doses), Rx Only, Distribute…

Recall date
August 9, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1821-2019
FDA classification
Class II
Brand / firm
American Health Packaging
Sold / distributed
Nationwide USA

Why it was recalled

Failed Dissolution Specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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

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