Drug product
Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11
D-0232-2021
Product summary
- Event
- Event 87154
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1948 cartons
- Official record key
drug-enforcement:D-0232-2021
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot # 193757, Exp 1/31/2022
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications