Drug & medication recalls Moderate risk

American Health Packaging recalls Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx on…

Recall date
January 7, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0232-2021
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

Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11

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