FDA recall D-0773-2026

Liebel-Flarsheim Company LLC · Class I · drug

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 for recall

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

Distribution

Distributed Nationwide in the US and Mexico.

Key facts

Status
Ongoing
Initiation date
2026-07-31
Report date
2026-08-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Raleigh, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0773-2026