NDC 51662-1568
Venofer (Iron Sucrose) 20 mg per 1 mL injection, solution
On the label: HF Acquisition Co. LLC. DBA HealthFirst. It's repackaged: HF Acquisition Co. LLC. DBA HealthFirst rebottles it from American Regent, Inc.'s NDC 0517-2340.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| American Regent, Inc. | Hilliard, OH, United States | Makes it | Problems found, fixed voluntarilyJun 18, 2026 · 8 inspections |
| American Regent, Inc. | Shirley, NY, United States | Makes it and tests it | Problems found, fixed voluntarilyApr 24, 2024 · 12 inspections, 1 with FDA action |
| Vifor (International) Inc. | St. Gallen, Switzerland | Makes it and makes the active ingredient | Problems found, fixed voluntarilySep 6, 2024 · 4 inspections |
| American Regent, Inc. | Columbus, OH, United States | Tests it | Problems found, fixed voluntarilyMar 5, 2026 · 8 inspections |
Repackaging site
- HF Acquisition Co LLC, Mukilteo, WA, United States · relabels it
Recalls
- Nov 11, 2024 · Class II · American Regent, Inc.
Presence of Particulate Matter: Potential for glass delamination from the vials.
Lots: Lot #s: 4205, Exp 05/31/2026; 24229, 24233, 24239, Exp 07/31/2026.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ferric Cation: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 20 mg per 1 mL
- Approval
- NDA NDA021135
- On the market since
- Jun 25, 2021
- Package NDCs
51662-1568-151662-1568-251662-1568-3- Official label
- DailyMed (National Library of Medicine), updated Apr 19, 2024
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