Cleviprex recall expanded due to presence of foreign matter
March 18th, 2010 joshua
The Medicines Company has expanded a previous recall on Cleviprex injectable emulsion because it contains visible particulate matter which could compromise a patient’s health.
Four more lots of Cleviprex are now included in the recall: 68-407-DJ, Exp. 08/2010; 68-408-DJ, Exp. 08/2011; 71-101-DJ and 71-106-DJ, Exp. 11/2011.
The following lots were previously recalled by The Medicines Company, according to a company release: 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.
According to the company, the visible matter is made of sub-visible inert stainless steel particles at 2.5 microns in diameter. These particles could lead to decreased blood flow in the capillaries, damage tissue and eventually cause more serious health side effects, including brain, kidney, liver, heart or lung damage.
