PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 16, 2022 Initiated: February 22, 2022 #D-0652-2022

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.

Details

Recalling Firm
American Health Packaging
Units Affected
89,880 unit-dose cups
Distribution
Nationwide in the USA
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
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. Recalled by American Health Packaging. Units affected: 89,880 unit-dose cups.
Why was this product recalled?
Impurity failure at 0-time of the repackaged lot.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 16, 2022. Severity: Moderate. Recall number: D-0652-2022.