Venofer Injection, Solution
FDA Recall NDC 49230-534
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Venofer (NDC 49230-534). A significant event, classified as Class II, was initiated on Nov 11, 2024 by Fresenius Medical Care Holdings, Inc.. The reported reason for this action was: "Presence of Particulate Matter: Potential for glass delamination from the vials."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of Particulate Matter: Potential for glass delamination from the vials.
Nov 11, 2024
Dec 11, 2024
N/A
Recall Profile & Regulatory Data
Event ID
95711
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
American Regent, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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).
Batch or Lot Expiration Information
Lot# s: 4196, Exp 05/31/2026
Affected Packages Involved in this Recall
49230-530-01Product
49230-530-10Product
49230-530-25Product
49230-534-01Product
49230-534-10Product
49230-534-25Product
Class II Ongoing
Presence of Particulate Matter: Potential for glass delamination from the vials.
Nov 11, 2024
Dec 11, 2024
N/A
Recall Profile & Regulatory Data
Event ID
95711
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
American Regent, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons).
Batch or Lot Expiration Information
Lot# s: 4206, 4210, Exp 05/31/2026; 4223, Exp 06/30/2026; 24231, 24237, Exp 07/31/2026.
Affected Packages Involved in this Recall
49230-530-01Product
49230-530-10Product
49230-530-25Product
49230-534-01Product
49230-534-10Product
49230-534-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
