Health

Alert

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

syringes.

Background

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.

Recommendations

1. Healthcare facilities and providers should not use these lots of Isovue PFS and quarantine the product.
2. Refer to the FDA notification for details on recalled product lot numbers (http://www.fda.gov/Safety/Recalls/ucm329740.htm).
3. Healthcare providers and patients are encouraged to report adverse events or side effects to the FDA MedWatch Safety Information andAdverse Event Reporting Program (www.fda.gov/MedWatch/report.htm).

Additional Information

• FDA MedWatch Alert: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm329948.htm?source=govdelivery.
• DPH Bureau of Epidemiology (24/7): 1-888-295-5156.

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