Drug product
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
D-0094-2024
Product summary
- Event
- Event 93254
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 3,792 bottles
- Official record key
drug-enforcement:D-0094-2024
Official wording
Reason: Sub-potent Drug: Lower potency than labeled.
Code information: Lot 22W02, Exp 01/31/2025
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Sub-potent Drug: Lower potency than labeled.