Liebel-flarsheim Company Llc: Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 Mg/ml Organically Bound Iodine
Recall Summary Liebel-Flarsheim Company LLC is recalling Optiray Imaging Bulk Package-350, a contrast injection used in medical imaging, because the 500 mL vials contain particles of plastic, stainless steel, and glass. The affected product was distributed nationwide across all U.S. states, Washington D.C., and Mexico. This is a Class I recall, meaning the contamination could cause serious health problems.
- Recalling firm
- 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
- Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-07-31
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Distributed Nationwide in the US and Mexico.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/7a871fdb-5af0-408b-81bf-94797e3c494f