Recall D-0082-2025

US Class II Ongoing · initiated 2024-11-11

Recalling firm

American Regent, Inc., NY

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, 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.

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