Class II · Moderate risk Ongoing
Nitrofurantoin Capsules
Reason Failed Dissolution Specifications
Nitrofurantoin Capsules
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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.
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
- Recalling firm
- American Health Packaging
- NDC code
- 68084-446-11
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0880-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Nitrofurantoin recalls
See all
Class II · Moderate risk Terminated
Nitrofurantoin Capsules
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Nitrofurantoin Capsules USP
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Nitrofurantoin Monohydrate/Macrycrystals Capsules
Reason Failed dissolution specifications
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