Status
Ongoing
Drug Enforcement D-0081-2025
Presence of Particulate Matter: Potential for glass delamination from the vials.
Classification
Class II
Report Date
December 11, 2024
Termination Date
—
Product Information
- Product description
- Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons).
- Product quantity
- —
- Reason for recall
- Presence of Particulate Matter: Potential for glass delamination from the vials.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- American Regent, Inc.
- Address
-
5 Ramsey Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0081-2025
- Event ID
- 95711
- Recall initiation date
- November 11, 2024
- Center classification date
- November 29, 2024
- Code info
- Lot #s: 4206, 4210, Exp 05/31/2026; 4223, Exp 06/30/2026; 24231, 24237, Exp 07/31/2026.
- More code info
- —