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.
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
| Recalling firm | Liebel-Flarsheim Company LLC |
|---|---|
| Reason | Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. |
| Risk class | Class I (Class I · high risk) |
| Status | Ongoing |
| Report date | Aug 19, 2026 |
| Initiated | Jul 31, 2026 |
| Region | NC, United States |
| Distribution | Distributed Nationwide in the US and Mexico. |
| Quantity | 3,486 500mL-vials |
| Code/Lot | Lot # 25ZF3670, Exp Date: May 31, 2027. |
| Type | Voluntary: Firm initiated |
| Recall number | D-0773-2026 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: D-0773-2026)
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