Class III
Terminated
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
- Company
- American Health Packaging
- Recall Initiated
- May 3, 2022
- Posted
- May 25, 2022
- Recall Number
- D-0880-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1603 cartons
- Firm Location
- Columbus, OH, United States
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.
Distribution
Nationwide USA
Lot / Code Info
Lot # 1003829, Exp date 1/31/23
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