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Mallinckrodt recalls One Lot of Sodium Chromate Injection

Covidien, a St. Louis based company, announced last week that its subsidiary Mallinckrodt Inc. is voluntary recalling one of its products, Sodium Chromate Injection # 370-9004 as a result of testing that has shown that the injection is not potent. The injection is used to determine a patient’s red blood cell volume and the life span of the patient’s red blood cells. Increased red blood cell volume is associated with a disease known as Polycythemia rubra vera, which is diagnosed by relying on various blood and other test results. A misdiagnosis or delayed diagnosis of Polycythemia can result in an increased risk of embolus or stroke.

Mallinckrodt has issued the recall to inform healthcare providers that the low potency of the Injection can lead to the potential of a false low reading of red blood cell volume which can lead to a misdiagnosis of Polycythemia. Customers who have product from the recalled lot in their possession should discontinue use immediately. Customers with questions about the recalled product, including returns, should contact Product Monitoring at 800-778-7898 (7:00 am to 5:00 pm CT).

For more information, see the FDA recall notice at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171396.htm

See the FDA Press Release:
http://www.fda.gov/Safety/Recalls/ucm171302.htm

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