FDAHealthNovember 11, 2024
American Regent, Inc. — 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 Ca
⚠️ Presence of Particulate Matter: Potential for glass delamination from the vials.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 11, 2024
Nationwide in the USA
What's affected?
- 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).
- Brand
- VENOFER
- UPC
- 0349230530254
- Lot code
- 4196
Additional details
Lot#s: 4196, Exp 05/31/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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