Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10...
FDA Recall #D-0652-2022 — Class II — February 22, 2022
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
Reason for Recall
Impurity failure at 0-time of the repackaged lot.
Recalling Firm
American Health Packaging — Columbus, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
89,880 unit-dose cups
Distribution
Nationwide in the USA
Code Information
Lot# 1004276, Exp 11/30/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated