Alerts
Sodium Chromate Cr-51 Injection Recall
July 13, 2009
Mallinckrodt, a subsidiary of Covidien, is recalling lot #370-9004 Sodium Chromate Cr-51. This lot was subpotent during routine post-manufacture testing. Sodium Chromate Cr-51 is a radiopharmaceutical agent for diagnosing polycythemia rubra vera. Subpotent product could lead to misdiagnosis and delayed treatment, putting the patient at increased risk for stroke or embolus.
Discontinue use of the affected lot immediately and consider rechecking the validity of recent tests if the affected product may have been used. For further questions or information on returning product, contact Covidien at 800-778-7898 (7:00 am to 5:00 pm CT), or refer to one of the links below.
- MedWatch Alert
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171396.htm - Press Release July 9, 2009
http://www.fda.gov/Safety/Recalls/ucm171302.htm
Updated
July 13, 2009; University of Utah, Drug Information Service.
Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
