FDAClass IIMarch 16, 2022

Oxycodone Hydrochloride Oral Solution recall: Impurity Out of Spec

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…

Why was Oxycodone Hydrochloride Oral Solution recalled?

Impurity failure at 0-time of the repackaged lot.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# 1004276, Exp 11/30/2022

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…
Recalling firm
American Health Packaging
Quantity
89,880 unit-dose cups
Distribution
Nationwide in the USA
Recall date
March 16, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls