The 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.

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