← FDA ENFORCEMENT
D-0080-2025Class II

American Regent, Inc.

Recalling firm
American Regent, Inc.
Product type
Drug
Status
Ongoing
Report date
2024-12-11
Distribution
Nationwide in the USA
Firm state
NY
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

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, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).

Code / lot info

Lot#s: 4196, Exp 05/31/2026

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.