---

---

Your facility has been identified as potentially purchasing Venofer® (Iron Sucrose) Injection between the dates of 01 August 2024 and 08 October 2024. Your facility may have received product affected by a recall.

This is to inform you that the following lots of Venofer^® (Iron Sucrose) Injection, USP: 4205, 24229, 24233, and 24239 are manufactured and distributed by American Regent, Inc. and are the subject of a voluntary Recall by the manufacturer. Recall of this product to USER LEVEL was initiated due to a potential for glass de-lamination of the vials.

Venofer ® (Iron Sucrose) Injection is indicated for the treatment of iron deficiency anemia (IDA) relative to chronic kidney disease (CKD) in the following patients:

• Adult Patients with Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD);
• Adult Patients with Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD);
• Adult Patients with Peritoneal Dialysis Dependent-Chronic Kidney Disease (PDD-CKD);
• Pediatric Patients (2 Years of Age and Older) with HDD-CKD for Iron Maintenance Treatment;
• Pediatric Patients (2 Years of Age and Older) with NDD-CKD or PDD-CKD who are on Erythropoietin Therapy for Iron Maintenance Treatment.

Risk Assessment:

The aforementioned lots may contain microscopic glass particles that could potentially cause adverse health effects if injected, including vascular injury, embolism, thrombosis, or local reactions at the injection site due to the delamination of glass flakes from the vial's inner surface. Any particulate matter/residue, even if totally dissolved, are not expected to cause adverse effects systemically due to the relatively low volume of Venofer injected. In this particular instance, there was no obvious solubility of the flakes/particulates expected. Sub-particles that may have dissolved from the flakes/particles are not likely to exist, and even if present, are not expected to cause clinical concern.

Based on the Toxicological and Safety analysis, when Venofer is used according to the approved prescribing procedures, at this time there is low potential risk of any particulate matter entering the systemic circulation with consequent adverse reactions or causing an immunologic or immunogenic response at the injection site.

ACTION(S):
Further use or distribution of the above-mentioned lots for Venofer® (Iron Sucrose) Injection, USP should cease immediately.

NOTE: This recall is specific to the Lots listed above, No other lots are impacted by this action.

You are hereby instructed to isolate your inventory of the above lot number. This recall requires a response letting American Regent know whether you have the product in question, or not.

The product should be returned directly to American Regent, Inc., by all accounts. American Regent, Inc. will be responsible for all shipping costs incurred.

Please use the form provided in this mailing for instructions on how to respond to this request.

Credit will be issued through your wholesaler.

Your cooperation is appreciated.

Sincerely,

American Regent, Inc.
Felix Martinson
Executive Director Quality Affairs