VOLUNTARY NATIONWIDE RECALL OF ISOVUE (IOPAMIDOL INJECTION) PRE-FILLED POWER INJECTOR SYRINGES BY
BRACCO DIAGNOSTICS, INC.
The Delaware Division of Public Health (DPH) is issuing this health alert to inform the medical community of the voluntary recall of
Isovue (iopamidol injection) pre-filled power injector syringes by Bracco Diagnostics, Inc. due to the presence of visible particles in
Isovue is indicated for angiography throughout the cardiovascular system. Although no reports of adverse events have been received,
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 (PFS)
presentations of Isovue - 300 FLS2 and Isovue - 370 FLS2. Distribution dates of the nine affected lots were from January 21, 2010 through
May 9, 2012.
- Healthcare facilities and providers should not use these lots of Isovue PFS and quarantine the product.
- Refer to the FDA notification for details on recalled product lot numbers (http://www.fda.gov/Safety/Recalls/ucm329740.htm).
- Healthcare providers and patients are encouraged to report adverse events or side effects to the FDA MedWatch Safety Information and
Adverse Event Reporting Program (www.fda.gov/MedWatch/report.htm).
You are receiving this message because you are a registered member of the Delaware Health Alert Network. If you are not a member and
would like to subscribe, please register at https://healthalertde.org
Categories of Health Alert messages:
- Health Alert: Conveys the highest level of importance; warrants immediate action or attention.
- Health Advisory: Provides important information for a specific incident or situation; may not require immediate action.
- Health Update: Provides updated information regarding an incident or situation; unlikely to require immediate action.
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