SpecGx, LLC: Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- SpecGx, LLC
- Product
- Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
- Reason / hazard
- Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide
- Recall initiated
- 2025-12-16
- Code info
- Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027.
- Product quantity
- 287,988 Bottles.
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Webster Groves
- State
- MO
- Country
- United States
- Event id
- 98136
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