FDA-Drug2026-01-14Class II

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

SpecGx, LLC
Hazard

Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

Sold states
Nationwide
Affected count
74,544 bottles
Manufactured in
385 Marshall Ave, Webster Groves, MO, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0255-2026

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