FDA-Drug2022-05-25Class III
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
American Health Packaging
Hazard
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.
Sold states
Nationwide USA
Affected count
1603 cartons
Manufactured in
2550 John Glenn Ave Ste A, N/A, Columbus, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0880-2022Don't want to check this manually?
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