Drug Enforcement D-0080-2025

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

Status

Ongoing

Classification

Class II

Report Date

December 11, 2024

Termination Date

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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, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons).
Product quantity
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Reason for recall
Presence of Particulate Matter: Potential for glass delamination from the vials.
Recall initiation reason
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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
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Codes & Dates

Recall number
D-0080-2025
Event ID
95711
Recall initiation date
November 11, 2024
Center classification date
November 29, 2024
Code info
Lot#s: 4196, Exp 05/31/2026
More code info
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