NDC 63187-823
Oxycodone and Acetaminophen 10 mg / 325 mg tablet
On the label: Proficient Rx LP. It's repackaged: Proficient Rx LP 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
- Proficient Rx LP, Thousand Oaks, CA, United States · repackages it and relabels 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, oral
- Strength
- 10 mg / 325 mg
- Approval
- ANDA ANDA201972
- On the market since
- Dec 1, 2016
- Package NDCs
63187-823-1563187-823-2063187-823-3063187-823-6063187-823-90- Official label
- DailyMed (National Library of Medicine), updated Oct 1, 2019
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?