D-0232-2021 Class II Terminated
FDA drug recall D-0232-2021 was initiated by American Health Packaging on January 7, 2021 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated August 3, 2022). Affected quantity: 1948 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- January 27, 2021
- Initiation Date
- January 7, 2021
- Termination Date
- August 3, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1948 cartons
Product Description
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
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide USA
Code Information
Lot # 193757, Exp 1/31/2022