NDC 72189-611
Oxycodone HCL 5 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from KVK-TECH, Inc.'s NDC 10702-018.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Kvk-Tech, Inc. | Newtown, PA, United States | Makes it | Serious problems, FDA actionMar 14, 2025 · 13 inspections, 3 with FDA action |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · repackages it
Recalls
- Jan 14, 2026 · Class II · Amerisource Health Services LLC
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Lots: Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Oxycodone: every company that makes it
- Form
- tablet, oral
- Strength
- 5 mg
- Approval
- ANDA ANDA091393
- On the market since
- Mar 24, 2025
- Package NDCs
72189-611-30- Official label
- DailyMed (National Library of Medicine), updated Mar 24, 2025
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