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FDA · Drugs ·

Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine recall

Liebel-Flarsheim Company LLC recalled Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine on August 19, 2026 because of presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. It was sold nationwide.

Why it was recalled

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

What's recalled

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.

Quantity: 3,486 500mL-vials

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice