FDAFDA · Food and drugs·Recall number D-0880-2022
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
Published May 25, 2022 · Recall initiated: May 3, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- American Health Packaging
- Distributor
- Nationwide USA
- Lot
- Lot # 1003829, Exp date 1/31/23
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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