Drug product
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
D-0254-2026
Product summary
- Firm
- SpecGx, LLC
- Event
- Event 98136
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 287,988 Bottles.
- Official record key
drug-enforcement:D-0254-2026
Official wording
Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Code information: Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.