Guerbet subsidiary Liebel-Flarsheim is recalling a lot of its Optiray (Ioversol) CT iodinated contrast agent due to the presence of particulate matter comprising polyethylene, other plastic materials, stainless steel, and glass.
"The administration of an injectable product containing particulate matter may result in local irritation or swelling," the company said in a July 31 announcement. "More serious risks in compromised patients include serious life-threatening events such as blockage of blood vessels and blood clots."
The affected Optiray lot -- NDC 0019-1333-65, lot 25ZF3670, expiring May 31, 2027 -- was distributed in the U.S. and Mexico to distributors, hospitals, imaging centers, healthcare facilities, and clinics. To date, the company has received no reports of adverse events related to the issue. Providers with the recalled product should immediately stop use, quarantine affected inventory, and follow return instructions in the customer recall notification, Liebel-Flarsheim said.
Questions can be directed to Inmar (Liebel-Flarsheim's recall processor) at [email protected] or +1-855-670-3976.
