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
Reported: May 25, 2022 Initiated: May 3, 2022 #D-0880-2022
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- American Health Packaging
- Units Affected
- 1603 cartons
- Distribution
- Nationwide USA
- Location
- Columbus, OH
Frequently Asked Questions
What product 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. Recalled by American Health Packaging. Units affected: 1603 cartons.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 25, 2022. Severity: Low. Recall number: D-0880-2022.
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