Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The Medicines Company is voluntarily expanding the recall of Cleviprex (clevidipine butyrate) injectable emulsion due to the potential presence of visible particulate matter which has been observed in some vials.
Subscribe to our email newsletter
The visible particulate matter is primarily made up of sub visible inert stainless steel particles of around 2.5 microns in diameter. Experimental animal and human data indicate that these particles are scavenged by macrophages and other cells of the reticuloendothelial system.
Particles can theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.
The Medicines Company has reported that four additional lots of Cleviprex 68-407-DJ, Exp 08/2010; 68-408-DJ, Exp 08/2011; 71-101-DJ and 71-106-DJ, Exp 11/2011 are being recalled.
The previously recalled lots were 61-978-DW, 61-979-DW, and 61-980-DW, Exp 01/2010; 68-404-DJ, 68-405-DJ, and 68-406-DJ, Exp 08/2010; 69-830-DJ, 63-385-DJ, 63-386-DJ, and 63-266-DJ, Exp 03/2011; and 64-453-DJ, Exp 04/2011. The company is cooperating with the FDA on this recall.