RecallDepth
Class II Ongoing

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).

This recall is currently active, issued December 11, 2024. It was issued by American Regent, Inc..

Company
American Regent, Inc.
Recall Initiated
November 11, 2024
Posted
December 11, 2024
Recall Number
D-0082-2025
Voluntary / Mandated
Voluntary: Firm initiated
Firm Location
Shirley, NY, United States
Official Source
View on FDA website ↗

Reason for Recall

Presence of Particulate Matter: Potential for glass delamination from the vials.

Distribution

Nationwide in the USA

Lot / Code Info

Lot #s: 4205, Exp 05/31/2026; 24229, 24233, 24239, Exp 07/31/2026.

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