Drug Enforcement D-0082-2025

Presence of Particulate Matter: Potential for glass delamination from the vials.

Status

Ongoing

Classification

Class II

Report Date

December 11, 2024

Termination Date

—

Product Information

Product description
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).
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-0082-2025
Event ID
95711
Recall initiation date
November 11, 2024
Center classification date
November 29, 2024
Code info
Lot #s: 4205, Exp 05/31/2026; 24229, 24233, 24239, Exp 07/31/2026.
More code info
—