American Health Packaging: Drug Recall

Recall #D-0854-2021 · 09/15/2021

Class II: Risk

Recall Details

Recall Number: D-0854-2021
Classification: Class II
Product Type: Drug
Recalling Firm: American Health Packaging
Status: Terminated
Date Initiated: 09/15/2021
Location: Columbus, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 548 ccases

Reason for Recall

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

Product Description

Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42

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.