D-0773-2026 Class I Ongoing
FDA drug recall D-0773-2026 was initiated by Liebel-Flarsheim Company LLC on July 31, 2026 and is designated Class I. Reason for recall: Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. The recall status is ongoing. Affected quantity: 3,486 500mL-vials.
Recall Details
- Product Type
- Drugs
- Report Date
- August 19, 2026
- Initiation Date
- July 31, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,486 500mL-vials
Product Description
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 Pattern
Distributed Nationwide in the US and Mexico.
Code Information
Lot # 25ZF3670, Exp Date: May 31, 2027.