Official recall notice

FDA DrugClass INotable

OPTIRAY Imaging Bulk Package 350 Recall (Aug 2026)

Product: OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml); 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 date
2026-08-04
Brand
OPTIRAY
Category
Drug
FDA class
Class I

Why it was recalled

Hazard

Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass

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Product description

Presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass

Affected products

Lot # 25ZF3670, Exp Date: May 31, 2027.

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