July 14, 2009
Mallinckrodt Sodium Chromate Cr-51 Injection recalledThe FDA and Covidien have announced a nationwide recall of one lot of Mallinckrodt Sodium Chromate Cr-51 Injection as a result of routine post-marketing testing which found the product to be subpotent. Sodium Chromate Cr-51 Injection is a radiopharmaceutical used in diagnostic testing to determine red blood cell (RBC) volume or mass, the study of RBC survival time, and evaluation of blood loss. Sodium Chromate Cr-51 Injection is used in the diagnosis of the disease polycythemia rubra vera, which is associated with increased RBC volume. A subpotent product could potentially lead to a false low reading of RBC volume and result in a misdiagnosis or delayed diagnosis, followed by a delay in treatment which puts patients at increased risk of embolus or stroke.
The lot being recalled is Lot #370-9004, consisting of 96 distributed vials. To date, 81 of the 96 vials have been accounted for by Covidien. Healthcare professionals who possess this product should discontinue its use immediately.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171396.htm.