Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose...
FDA Recall #D-0082-2025 — 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, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (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: 4205, Exp 05/31/2026; 24229, 24233, 24239, Exp 07/31/2026.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated