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Liebel-Flarsheim Company LLC recalls Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial,

Recalled August 19, 2026 · FDA recall D-0773-2026 · Liebel-Flarsheim

Hazard
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. · FDA Class I
Units
3,486 500mL-vials
Sold at
Distributed Nationwide in the US and Mexico.

Description

Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

Product
Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made in USA, NDC 0019-1333-65.
Manufacturer(s)
Liebel-Flarsheim Company LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov