FDA recall D-0652-2022

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

Reason for recall

Impurity failure at 0-time of the repackaged lot.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-02-22

Report date

2022-03-16

Termination date

2023-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

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