American Health Packaging recalls Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 1…

Recall date

May 3, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0880-2022

FDA classification

Class III

Brand / firm

American Health Packaging

Sold / distributed

Nationwide USA

Why it was recalled

Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01