American Health Packaging: Drug Recall

Recall #D-0232-2021 · 01/07/2021

Class II: Risk

Recall Details

Recall Number: D-0232-2021
Classification: Class II
Product Type: Drug
Recalling Firm: American Health Packaging
Status: Terminated
Date Initiated: 01/07/2021
Location: Columbus, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1948 cartons

Reason for Recall

Failed Dissolution Specifications

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

Distribution Pattern

Nationwide USA

Other Recalls by American Health Packaging

Class III: Low Risk 05/03/2022

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.
Class III: Low Risk 04/12/2022

Subpotent Drug: Out of specification for assay.
Class II: Risk 02/22/2022

Impurity failure at 0-time of the repackaged lot.
Class II: Risk 12/20/2021

Failed Dissolution Specifications
Class II: Risk 09/17/2021

Failed Dissolution Specifications: results were above specification.

View all recalls by American Health Packaging →

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.