NDC 54868-5338
Oxycodone And Acetaminophen 325 mg / 7.5 mg tablet
On the label: Physicians Total Care, Inc.. It's repackaged: Physicians Total Care, Inc. rebottles it from SpecGx LLC's NDC 0406-0522.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| SpecGx LLC | Hobart, NY, United States | Makes it and tests it | No problems foundMar 13, 2020 · 6 inspections |
| SpecGx LLC | St. Louis, MO, United States | Makes the active ingredient | Problems found, fixed voluntarilyOct 22, 2025 · 8 inspections |
| SpecGx LLC | Greenville, IL, United States | Makes the active ingredient | Problems found, fixed voluntarilyFeb 27, 2026 · 5 inspections |
Repackaging site
- Physicians Total Care, Inc., Tulsa, Oklahoma, United States · repackages it and relabels it
Recalls
- Dec 16, 2025 · Class II · SpecGx, LLC
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Lots: Lot: 0523J23904, expires: 05/2027; 0523J24426, 0523J24427, expires: 06/2027. - Dec 16, 2025 · Class II · SpecGx, LLC
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Lots: Lot: 0522J23493, expires: 03/2027.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Acetaminophen and Oxycodone: every company that makes it
- Form
- tablet
- Strength
- 325 mg / 7.5 mg
- Approval
- ANDA ANDA040545
- On the market since
- Oct 14, 2008
- Package NDCs
54868-5338-054868-5338-154868-5338-254868-5338-354868-5338-454868-5338-554868-5338-654868-5338-754868-5338-8- Official label
- DailyMed (National Library of Medicine), updated Jan 24, 2014
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