FDA-Drug2022-03-16Class II

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

American Health Packaging
Hazard

Impurity failure at 0-time of the repackaged lot.

Sold states
Nationwide in the USA
Affected count
89,880 unit-dose cups
Manufactured in
2550 John Glenn Ave Ste A, N/A, Columbus, OH, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0652-2022

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