Drug Recall: 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 (
American Regent, Inc. · November 11, 2024
Reason for Recall
Presence of Particulate Matter: Potential for glass delamination from the vials.
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).
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0082-2025
Status: ongoing
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