American Regent, Inc.: Drug Recall

Recall #D-0080-2025 · 11/11/2024

Class II: Risk

Recall Details

Recall Number: D-0080-2025
Classification: Class II
Product Type: Drug
Recalling Firm: American Regent, Inc.
Status: Ongoing
Date Initiated: 11/11/2024
Location: Shirley, NY, United States
Voluntary/Mandated: Voluntary: Firm initiated

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, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).

Distribution Pattern

Nationwide in the USA

Other Recalls by American Regent, Inc.

Class II: Risk 04/18/2025

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II: Risk 04/18/2025

Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Class II: Risk 11/11/2024

Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II: Risk 11/11/2024

Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II: Risk 05/14/2024

Lack of Assurance of Sterility.

View all recalls by American Regent, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.