Drug product
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
D-0880-2022
Product summary
- Event
- Event 90191
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1603 cartons
- Official record key
drug-enforcement:D-0880-2022
Official wording
Reason: 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.
Code information: Lot # 1003829, Exp date 1/31/23
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications