Covidien's subsidiary Mallinckrodt has recalled one lot of Sodium Chromate Cr-51 injection as a result of routine post-market testing, which found the product to be subpotent.
The lot [#370-9004] of Sodium Chromate Cr-51 injection is a radiopharmaceutical agent used to determine the presence of Polycythemia rubra vera, according to the Dublin, Ohio-based Covidien and the FDA. Polycythemia rubra vera, or erythremia, occurs when excess red blood cells are produced as a result of an abnormality of the bone marrow.
The company said using subpotent product could lead to an incorrect test result. A misdiagnosis or delayed diagnosis followed by a delay in treatment puts patients at an increased risk of embolus or stroke. This recall is being conducted to inform healthcare providers of the potential for a false low reading of red blood cell volume and to prevent further use of the product.
Covidien said it decided to recall the lot consisting of 96 distributed vials on June 23, and has been in the process of recovering those vials from customers in the United States, Canada and Mexico. To date, the FDA said that the company has accounted for 81 of the 96 vials (84 percent). Also, no adverse events or complaints have been reported with this product.
The FDA and Coviden advised customers who have product from the recalled lot to "discontinue use immediately."