Reported Dec 11, 2024 · Ongoing
Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only,…
American Regent, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Regent, Inc. · 5 Ramsey Rd · Shirley, NY · 11967-4701
Is this the product you have?
- Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only
- Distributed byFresenius Medical Care NA, Waltham, MA 02451
- NDC49230-530-01 (vial)
- NDC49230-530-10 (10 x 2.5mL/vial cartons)
- NDC49230-530-25 (25 x 2.5mL/vial cartons)
- Lot codes and dates
Lot #s: 42064210Exp 05/31/20264223Exp 06/30/20262423124237Exp 07/31/2026
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Presence of Particulate Matter: Potential for glass delamination from the vials.
This product could cause temporary or reversible health problems — stop using it.
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