← FDA ENFORCEMENT
D-0094-2024Class III

Zyla Life Sciences US Inc.

Recalling firm
Zyla Life Sciences US Inc.
Product type
Drug
Status
Ongoing
Report date
2023-11-15
Distribution
Nationwide
Firm state
IL
Product quantity
3,792 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
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

Code / lot info

Lot 22W02, Exp 01/31/2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.