NDC 84549-460
Dextrose 50 mg per 1 mL injection, solution
On the label: ProPharma Distribution. It's repackaged: ProPharma Distribution rebottles it from Fresenius Kabi USA, LLC's NDC 65219-460.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Wilson, NC, United States | Makes it and tests it | Problems found, fixed voluntarilyFeb 13, 2026 · 5 inspections |
Repackaging site
- ProPharma Distribution, Westminster, CO, United States · repackages it and relabels it
Recalls
- Mar 11, 2026 · Class II · Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
Lots: Batch# 6402296, Exp Date: 07/31/2026. - Mar 11, 2026 · Class II · Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
Lots: Batch# 6402399, 6402400, 6402401, Exp Date: 02/28/2027. - Mar 11, 2026 · Class II · Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
Lots: Batch# 6402165, Exp Date: 05/30/2028.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Anhydrous Dextrose: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 50 mg per 1 mL
- Approval
- ANDA ANDA207449
- On the market since
- Jul 9, 2024
- Package NDCs
84549-460-20- Official label
- DailyMed (National Library of Medicine), updated Sep 17, 2025
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