NDC 61919-437
Oxycodone And Acetaminophen 10 mg / 325 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Aurolife Pharma LLC's NDC 13107-046.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Aurolife Pharma LLC | Dayton, NJ, United States | Makes it | Serious problems, FDA actionDec 7, 2021 · 10 inspections, 1 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Mar 18, 2020 · Class II · Aurobindo Pharma USA Inc.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Lots: Lot #: 046180056A, Exp. Date 05/2020
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
- 10 mg / 325 mg
- Approval
- ANDA ANDA201972
- On the market since
- Mar 12, 2018
- Package NDCs
61919-437-3061919-437-60- Official label
- DailyMed (National Library of Medicine), updated Oct 14, 2019
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