Bracco Issues Voluntary Recall of Isovue Pre-filled Syringes

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Bracco Diagnostics Inc. (BDI) has voluntarily initiated a Class I recall of nine lots of Isovue® (iopamidol injection) Pre-Filled Power Injector Syringes (Isovue PFS, to be 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, according to the U.S. Food and Drug Administration (FDA).

The FDA has full knowledge of the voluntary recall and is helping spread the word about it to providers and patients.
There have been no complaints or reports of patient harm arising from use of these nine recalled lots of Isovue. However, the FDA warned that the injections with the visible particle matter do have the potential to cause “adverse health consequences,” and should definitely not be used.

Isovue is used for angiography throughout the cardiovascular system, and arterial injection of Isovue (for cerebral angiography) with particulate matter formation could cause a stroke.

Bracco sold the lots to wholesalers and distributors nationwide between January 21, 2010 and May 9, 2012. The company has sent letters about the recall to its wholesalers, distributors and customers, and arranged for them to return any unused isovue injections that were part of the recall.

Diagnostic imaging providers should check their stocks of Isovue PFS and “immediately quarantine” any injections that were part of the following lots:

Isovue® - 370 NDC Description Lot Number Expiry Date
Isovue® - 370 FLS2 0270-1316-66 10 X 75 mL Power Injector Syringes, Stellant 9L40746 12/31/2012
Isovue® - 370 FLS2 0270-1316-67 10 X 100 mL Power Injector Syringes, Stellant 0A43705 01/31/2013
Isovue® - 370 FLS2 0270-1316-67 10 X 100 mL Power Injector Syringes, Stellant 0C57509 03/31/2013
Isovue® - 370 FLS2 0270-1316-68 10 X 125 mL Power Injector Syringes, Stellant 9K37791 11/30/2012
Isovue® - 370 FLS2 0270-1316-68 10 X 125 mL Power Injector Syringes, Stellant 0C57521 03/31/2013
Isovue® - 370 FLS2 0270-1316-68 10 X 125 mL Power Injector Syringes, Stellant 0E62913 05/31/2013
Isovue® - 300 NDC Description Lot Number Expiry Date
Isovue® - 300 FLS2 0270-1315-67 10 X 100 mL Power Injector Syringes, Stellant 9K34572 11/30/2012
Isovue® - 300 FLS2 0270-1315-67 10 X 100 mL Power Injector Syringes, Stellant 0A43282 01/31/2013
Isovue® - 300 FLS2 0270-1315-67 10 X 100 mL Power Injector Syringes, Stellant 0C56283 03/31/2013

To view pictures of the product labels on the FDA’s website, please click here.

If you have an affected product in stock, Bracco asks that you contact Stericycle, its contractor for handling the recall, at 1-866-201-9133 to arrange for return of the product. Call center hours are Monday through Friday 8 a.m. to 5 p.m. Eastern Standard Time.

Consumers with questions can also contact Stericyclen at that same number.