Recall: D-0773-2026

Class I - Dangerous

Class IClassification

2026-07-31Initiated

OngoingStatus

Liebel-Flarsheim Company LLCFirm

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.

Reason

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

Distribution

Distributed Nationwide in the US and Mexico.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.