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FDARecalled Dec 11, 2024 · #D-0080-2025

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 02...

Hazard

Class II — temporary health risk

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Description

Presence of Particulate Matter: Potential for glass delamination from the vials. Classification: Class II Distribution: Nationwide in the USA

Product details

Product
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).
Type
Drugs
Manufacturer
American Regent, Inc.
Model numbers
UPCs