Nationwide Recall for Certain Lots of Cleviprex Expanded

Parsippany, NJ: The Medicines Company is 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.

Four (4) additional lots of Cleviprex are being recalled. The four additional Cleviprex lots are 68-407-DJ, Exp. 08/2010; 68-408-DJ, Exp. 08/2011; 71-101-DJ and 71-106-DJ, Exp. 11/2011. 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 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 could 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.

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Published on Mar-22-10