NDC 49230-534
Venofer 20 mg per 1 mL injection, solution
On the label: Fresenius Medical Care Holdings, Inc..
Where it's 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 |
Recalls
- Nov 11, 2024 · Class II · American Regent, Inc.
Presence of Particulate Matter: Potential for glass delamination from the vials.
Lots: Lot#s: 4196, Exp 05/31/2026 - Nov 11, 2024 · Class II · American Regent, Inc.
Presence of Particulate Matter: Potential for glass delamination from the vials.
Lots: Lot #s: 4206, 4210, Exp 05/31/2026; 4223, Exp 06/30/2026; 24231, 24237, 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
- Nov 4, 2008
- Package NDCs
49230-534-0149230-534-1049230-534-25- Official label
- DailyMed (National Library of Medicine), updated Jun 1, 2022
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