The Mallinckrodt subsidiary of Dublin, Ireland-based Covidien has begun a voluntary recall of one lot of its sodium chromate Cr-51 injection product.
Lot #370-9004 from the St. Louis, MO-based company is being taken off the shelf after routine postmarket testing showed the product was subpotent. The injection is a radiopharmaceutical diagnostic agent used to determine red blood cell volume or mass, the study of red blood cell survival time, and evaluation of blood loss.
According to the safety notice from U.S. Food and Drug Administration (FDA), 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.
The lot consists of 96 vials, which were distributed on June 23. Mallinckrodt has been in the process of recovering those vials from customers in the U.S., Canada, and Mexico. So far, the company said it has accounted for 81 of the 96 vials.
Covidien noted that no adverse events or complaints have been reported from the product.
The FDA recommends that customers who have product from the recalled lot should discontinue use immediately. Customers with questions about the recalled product, including returns, can contact FDA Product Monitoring at 800-778-7898 from 7 a.m. to 5 p.m. central time.
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