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
Read the official notice at FDA (press release) →
The text below is copied from the official FDA (press release) 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
- Product type
- Drugs,
- Brand name
- OPTIRAY
- 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
- Enforcement url
- https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99510
- Enforcement id
- fda-drug-D-0773-2026
- Announced product
- OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml)
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