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.

Recall Number: D-0773-2026

Firm: Liebel-Flarsheim Company LLC

Classification: Class I

Status: Ongoing

Report Date: 20260819

Initiation Date: 20260731

Termination Date:

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

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.