Covidien announced that its Mallinckrodt Inc. subsidiary is voluntarily recalling one lot of Mallinckrodt Sodium Chromate Cr-51 Injection, lot #370-9004 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 diagnostic agent used in the determination of red blood cell volume or mass, the study of red blood cell survival time and evaluation of blood loss. 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. Using subpotent product could lead to an incorrect result in red blood cell volume or mass. 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 decided to recall lot #370-9004, consisting of 96 distributed vials, on June 23, 2009, and has been in the process of recovering those vials from customers in the U.S., Canada and Mexico. To date, the Company has accounted for 81 of the 96 vials (84%). No adverse events or complaints have been reported with this product and this is a very small product line for Covidien.
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 questions about credit for the product, please call Customer Service at 888-744-1414, menu option 1, then menu option 2.
Patients residing in the United States who experience adverse reactions associated with the use of this product from this lot should report them to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
* Online: www.fda.gov/medwatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to: MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: 1-800-332-0178