D-0652-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 16, 2022
- Initiation Date
- February 22, 2022
- Termination Date
- July 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89,880 unit-dose cups
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot# 1004276, Exp 11/30/2022