Drug 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).
D-0080-2025
Product summary
- Event
- Event 95711
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0080-2025
Official wording
Reason: Presence of Particulate Matter: Potential for glass delamination from the vials.
Code information: Lot#s: 4196, Exp 05/31/2026
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter