NDC 53002-1655
Oseltamivir Phosphate 6 mg per 1 mL powder, for suspension
On the label: RPK Pharmaceuticals, Inc.. It's repackaged: RPK Pharmaceuticals, Inc. rebottles it from Lupin Pharmaceuticals, Inc.'s NDC 68180-678.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Lupin Limited | Chhatrapati Sambhajinagar, India | Makes it and packages it | Problems found, fixed voluntarilyMar 15, 2024 · 5 inspections |
Repackaging site
- RPK Pharmaceuticals, Inc., Union City, California, United States · relabels it
Recalls
- Jan 21, 2021 · Class III · Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Lots: Lot # A906423, exp. date Nov 2021.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Oseltamivir Acid: every company that makes it
- Form
- powder, for suspension
- Strength
- 6 mg per 1 mL
- Approval
- ANDA ANDA208347
- On the market since
- Feb 21, 2018
- Package NDCs
53002-1655-1- Official label
- DailyMed (National Library of Medicine), updated Jun 6, 2023
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