Drug recall D-0080-2025
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, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).
Reason for recall
Presence of Particulate Matter: Potential for glass delamination from the vials.
Lots and codes
Lot#s: 4196, Exp 05/31/2026
Recall details
- Recalling firm
- American Regent, Inc., Shirley, NY
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 11, 2024
Related products
- Venofer – drug information
- NDC 49230-530 Venofer · Iron Sucrose 20 mg/mL · Fresenius Medical Care Holdings, Inc.
- NDC 49230-534 Venofer · Iron Sucrose 20 mg/mL · Fresenius Medical Care Holdings, Inc.