Bracco Diagnostics Inc. Issues Voluntary Nationwide Recall of Isovue® (iopamidol injection) Pre-Filled Power Injector Syringes due to Presence of Particulates

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Wed, 28 Nov 2012 18:34:10 -0600

Title: 
    Bracco Diagnostics Inc. Issues Voluntary Nationwide Recall of Isovue® (iopamidol injection) Pre-Filled Power Injector Syringes due to Presence of Particulates

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Bracco Diagnostics Inc. Issues Voluntary Nationwide Recall of Isovue® (iopamidol injection) Pre-Filled Power Injector Syringes due to Presence of Particulates
11/28/2012 10:27 AM EST

Bracco Diagnostics Inc. (BDI) is voluntarily initiating a Class I recall of nine (9) 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.

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