American Health Packaging: Drug Recall
Recall #D-0880-2022 · 05/03/2022
Class III: Low Risk
Recall Details
- Recall Number
- D-0880-2022
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- American Health Packaging
- Status
- Terminated
- Date Initiated
- 05/03/2022
- Location
- Columbus, OH, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1603 cartons
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.
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
Distribution Pattern
Nationwide USA
Other Recalls by American Health Packaging
- Class III: Low Risk 04/12/2022
- Class II: Risk 02/22/2022
- Class II: Risk 12/20/2021
- Class II: Risk 09/17/2021
- Class II: Risk 09/15/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.