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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.
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