Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose...
FDA Recall #D-0080-2025 — Class II — November 11, 2024
Product Description
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).
Reason for Recall
Presence of Particulate Matter: Potential for glass delamination from the vials.
Recalling Firm
American Regent, Inc. — Shirley, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Distribution
Nationwide in the USA
Code Information
Lot#s: 4196, Exp 05/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated