Drug product
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493
D-0255-2026
Product summary
- Firm
- SpecGx, LLC
- Event
- Event 98136
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 74,544 bottles
- Official record key
drug-enforcement:D-0255-2026
Official wording
Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Code information: Lot: 0522J23493, expires: 03/2027.
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.