FDAHealthJuly 31, 2026
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 Solution, Manufactured by: Lieb
⚠️ Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 31, 2026
Distributed Nationwide in the US and Mexico.
What's affected?
- 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.
- Brand
- OPTIRAY
- UPC
- 0300191332653
- Lot code
- 25ZF3670
Additional details
Lot # 25ZF3670, Exp Date: May 31, 2027.
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 3,486 500mL-vials.
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