OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml)
Product details
- OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial (Ioversol Injection 74% 350 mg iodine/ml)
Company announcement
Liebel-Flarsheim Company, LLC is recalling one lot of OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial due to the presence of particulate matter.
The affected product was distributed nationwide in the United States and to Mexico.
No adverse events have been reported to date in connection with this issue.
Risk:
The administration of an injectable product containing particulate matter may result in local irritation or swelling. More serious risks in compromised patients include serious life-threatening events such as blockage of blood vessels and blood clots.
Impacted states: Nationwide
Products:
- OPTIRAY Imaging Bulk Package (IBP) 350, 500mL in vial, (Ioversol Injection 74% 350 mg iodine/ml) Multiple-Dose Container. Packaged in cases of 6 vials (UPC code(s): 0019133365)
Contact
For more information, call 1-855-670-3976 or email rxrecalls@inmar.com.
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