CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure
MedSun: Newsletter #69, February 2012

FDA MedWatch Safety Alert

FDA is updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82 by the manufacturer. FDA continues to work with the manufacturer and other federal agencies to better characterize the problems that led to excessive radiation exposure to patients at certain clinical sites, and is working with the manufacturer to revise the CardioGen-82 labeling to better describe how to use the generator.

Additional Information:

FDA Drug Safety Communication. CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure. January 12, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm263157.htm


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