Zyla Life Sciences US Inc.: Drug Recall

Recall #D-0094-2024 · 10/20/2023

Class III: Low Risk

Recall Details

Recall Number
D-0094-2024
Classification
Class III
Product Type
Drug
Recalling Firm
Zyla Life Sciences US Inc.
Status
Ongoing
Date Initiated
10/20/2023
Location
Lake Forest, IL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,792 bottles

Reason for Recall

Sub-potent Drug: Lower potency than labeled.

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

Distribution Pattern

Nationwide

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.