Recall - OPTIRAY (OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml)) produced by Liebel-Flarsheim Company, LLC - Presene of[...]

Summary

Company Announcement

FOR IMMEDIATE RELEASE - July 31, 2026 - Raleigh, North Carolina, Liebel-Flarsheim Company, LLC, is recalling one lot of OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial, (Ioversol Injection 74% 350 mg iodine/ml) for intra-arterial or intra-venous use to the user level (hospitals, imaging centers, healthcare facilities and clinics, and other potential users of the product) due to the presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass.

Risk Statement: The administration of an injectable product containing particulate matter may result in local irritation or swelling. More serious risks in compromised patients include serious life-threatening events such as blockage of blood vessels and blood clots. To date, Liebel-Flarsheim Company, LLC, has not received any reports of adverse events related to this issue.

The product is used as a radiographic contrast agent.

The recalled product can be identified as follows:

The affected OPTIRAY 350 IBP 500mL was distributed in the United States and Mexico to distributors and end users (such as hospitals, imaging centers, healthcare facilities and clinics).

Liebel-Flarsheim Company, LLC, is notifying its distributors and customers by email and is arranging for return and replacement of all recalled products. Distributors, hospitals, healthcare facilities and clinics, and other healthcare providers that have the recalled product should immediately stop use and/or further distribution, quarantine all affected product inventory, and follow the instructions in the customer recall notification for arranging return of the affected lot to Liebel-Flarsheim Company, LLC.

Consumers with questions regarding this recall can contact Liebel-Flarsheim Company, LLC:

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.