NDC 64950-353
Oxycodone Hydrochloride 100 mg per 5 mL solution
On the label: Genus Lifesciences Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Genus Lifesciences Inc. | Allentown, PA, United States | Makes it, tests it, packages it and labels it | No problems foundJul 31, 2024 · 11 inspections, 1 with FDA action |
Recalls
- Dec 23, 2020 · Class III · Genus Lifesciences Inc.
Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Lots: Lot # 35400119A, 35400219A, 35400319A, 35400419A , 35400519A , 35400619A, EXP 12/31/20; 35400719A, 35400819A, EXP 1/31/21; 35400919A, 35401019A, 35401119A, EXP 2/28/21; 35401219A, 35401319A, EXP 4/30/21; 35401419A, 35401519A, 35401619A, EXP 5/31/21; 35401719A, 35401819A, EXP 7/31/21; 35401919A, 3…
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Oxycodone: every company that makes it
- Form
- solution
- Strength
- 100 mg per 5 mL
- Approval
- NDA NDA200535
- On the market since
- Oct 20, 2010
- Package NDCs
64950-353-0164950-353-0264950-353-0364950-353-5164950-353-5264950-353-9164950-353-92- Official label
- DailyMed (National Library of Medicine), updated Apr 16, 2026
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