FDARecalled Dec 11, 2024 · #D-0082-2025
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, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-0...
Hazard
Class II — temporary health risk
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Presence of Particulate Matter: Potential for glass delamination from the vials. Classification: Class II Distribution: Nationwide in the USA
Product details
- 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, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (vial), NDC: 0517-2340-10 (10 x 5 mL/vial cartons), NDC: 0517-2340-25 (25 x 5 mL/vial cartons).
- Type
- Drugs
- Manufacturer
- American Regent, Inc.
- Model numbers
- —
- UPCs
- —