United StatesOptiray Imaging Bulk Package-350 (Ioversol Injection 74%, 350 mg/mL, 500 mL multiple‑dose vial; NDC 0019-1333-65), lot 25ZF3670, exp. May 31, 2027, manufactured by Liebel‑Flarsheim Company LLC, distributed nationwide in the United States and Mexico (3,486 500 mL vials), is being recalled. The product was recalled for presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass.
What's being 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.
Recalling firm: Liebel-Flarsheim Company LLC, Raleigh, NC, United States.
How to identify it
Lot # 25ZF3670, Exp Date: May 31, 2027.
The hazard
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Distributed Nationwide in the US and Mexico.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)