Bracco Diagnostics is voluntarily initiating a Class I recall of nine lots of iopamidol injection (Isovue) prefilled power injector syringes (PFS), which are used in combination with Stellant CT injection systems, due to the presence of visible particles in syringes observed at the end of standard stability studies on retained samples.
These products were distributed to wholesalers and distributors across the U.S. Bracco said it has received no reports of adverse events or customer complaints associated with these lots. However, it should be noted that the visible particles in the lots subject to this recall have the potential to cause adverse health consequences.
The dates for distribution of the nine affected lots were from Jan. 21, 2010 through May 9, 2012.
Isovue is indicated for angiography throughout the cardiovascular system. Arterial injection of Isovue (for cerebral angiography) with particulate matter formation could cause stroke. Isovue PFS is a single use item, administered for diagnostic imaging under medical supervision. The product is packaged in single dose prefilled syringe presentations of Isovue-300 FLS2 and Isovue-370 FLS2.
According to the FDA MedWatch announcement, hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use these lots of Isovue PFS. They should immediately quarantine the product and contact Stericycle, Bracco’s contractor for handling the recall, to arrange for return of the product. The affected lots are listed on the FDA's website.