WhichRecall
Class IIReported 2024-12-11

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).

Recalled by American Regent, Inc.

Reason for Recall

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

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Recall Number
D-0080-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2024-11-11
Reported
2024-12-11
Distribution
Nationwide in the USA
Code Info
Lot#s: 4196, Exp 05/31/2026
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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