Drug product
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
D-0652-2022
Product summary
- Event
- Event 89670
- Status
- Terminated
- Classification
- Class II
- Quantity
- 89,880 unit-dose cups
- Official record key
drug-enforcement:D-0652-2022
Official wording
Reason: Impurity failure at 0-time of the repackaged lot.
Code information: Lot# 1004276, Exp 11/30/2022
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Impurity failure at 0-time of the repackaged lot.