FDA-Drug2024-12-11Class II
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).
American Regent, Inc.
Hazard
Presence of Particulate Matter: Potential for glass delamination from the vials.
Sold states
Nationwide in the USA
Manufactured in
5 Ramsey Rd, Shirley, NY, United States
Products
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0080-2025Don't want to check this manually?
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