Class I recall: Liebel-Flarsheim Company LLC: Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically

The FDA has classified a Class I recall for Liebel-Flarsheim Company LLC's Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, in 500 mL multiple-dose vials (NDC 0019-1333-65). The recall was initiated due to the presence of particulate matter identified as polyethylene and other plastic materials, stainless steel, and glass. Class I recalls are used by the FDA for situations in which use of the affected product could cause serious injury or death.”

Most relevant for: patients undergoing cardiac imaging procedures requiring intravenous contrast injection

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