Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc.
Summary
The FDA issued a Class III for Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Di by Zyla Life Sciences US Inc.. Reason: Sub-potent Drug: Lower potency than labeled..
Details
Source
Drug Recall
External ID
D-0094-2024
Action Date
2023-11-15
Status
Ongoing
Category
drug
Product Description
Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11
Lot/Code Info: Lot 22W02, Exp 01/31/2025
Quantity Affected: 3,792 bottles
Reason for Recall
Sub-potent Drug: Lower potency than labeled.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-20
Company
Lake Forest, IL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Zyla Life Sciences US Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zyla Life Sciences US Inc. have FDA actions?
This is the only FDA action we have on record for Zyla Life Sciences US Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0094-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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