Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyl...
FDA Recall #D-0094-2024 — Class III — October 20, 2023
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
Reason for Recall
Sub-potent Drug: Lower potency than labeled.
Recalling Firm
Zyla Life Sciences US Inc. — Lake Forest, IL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
3,792 bottles
Distribution
Nationwide
Code Information
Lot 22W02, Exp 01/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated