FDA recall D-0082-2025

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).

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2024-11-11

Report date

2024-12-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Shirley, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0082-2025