Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Ins
Summary
The FDA issued a Class II for Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per by American Health Packaging. Reason: Impurity failure at 0-time of the repackaged lot..
Details
Source
Drug Recall
External ID
D-0652-2022
Action Date
2022-03-16
Status
Terminated
Category
drug
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
Lot/Code Info: Lot# 1004276, Exp 11/30/2022
Quantity Affected: 89,880 unit-dose cups
Reason for Recall
Impurity failure at 0-time of the repackaged lot.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-22
Company
Columbus, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 20 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
American Health Packaging has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (American Health Packaging) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Health Packaging have FDA actions?
American Health Packaging has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0652-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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