FDA Drugs recall ·
Optiray Imaging Bulk Package-350, Ioversol Injection 74%… recall
This is an FDA Class I recall — the most serious type.
Read the official FDA notice ↗
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.
Why was it recalled?
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 25ZF3670, Exp Date: May 31, 2027.
Distribution
Distributed Nationwide in the US and Mexico.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0773-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.