American Health Packaging: Drug Recall

Recall #D-0652-2022 · 02/22/2022

Class II: Risk

Recall Details

Recall Number: D-0652-2022
Classification: Class II
Product Type: Drug
Recalling Firm: American Health Packaging
Status: Terminated
Date Initiated: 02/22/2022
Location: Columbus, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 89,880 unit-dose cups

Reason for Recall

Impurity failure at 0-time of the repackaged lot.

Product Description

Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Case NDC#: 60687-406-77, Unit Dose NDC#: 60687-406-40

Distribution Pattern

Nationwide in the 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 12/20/2021

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

Failed Dissolution Specifications: results were above specification.
Class II: Risk 09/15/2021

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

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.