⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Liebel-Flarsheim Company LLC: Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile So

DrugsSource: FDA (drug) · Date: 2026-08-19

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Liebel-Flarsheim Company LLC
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 / hazard
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Classification
Class I
Status
Ongoing
Distribution / sold at
Distributed Nationwide in the US and Mexico.
Recall initiated
2026-07-31
Code info
Lot # 25ZF3670, Exp Date: May 31, 2027.
Product quantity
3,486 500mL-vials
Voluntary mandated
Voluntary: Firm initiated
City
Raleigh
State
NC
Country
United States
Event id
99510
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