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Mallinckrodt Sodium Chromate Cr-51 Injection

Audience: Hematology and Nuclear Medical healthcare professionals, hospital risk managers

Covidien and FDA announced the recall of one lot [#370-9004] of Mallinckrodt Sodium Chromate Cr-51 Injection as a result of routine post-market testing in which the product was found to be subpotent. Sodium Chromate Cr-51 Injection is a radiopharmaceutical agent used in a diagnostic test to determine the presence of a disease known as Polycythemia rubra vera. 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. 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).

[07/10/2009 - Press Release - FDA]

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