The Medicines Company announced today that it is voluntarily recalling 11 lots of Cleviprex (clevidipine butyrate), an injectable emulsion used for the reduction of blood pressure, due to the potential presence of visible particulate matter, which has been observed in some vials during a routine annual inspection.
The affected Cleviprex lots are 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. No other lots are affected by this recall, according the Parsippany, N.J.-based company.
The particulate matter comprises sub-visible inert stainless steel particles of around 2.5 microns. When present in low numbers as observed, according to Medicines, particles of this size are not known to constitute a health hazard. Experimental animal and human data indicate that they are scavenged by macrophages and other cells of the reticuloendothelial system without adverse effects.
Although aggregates have not been observed, if the sub-visible particles were to aggregate, or if larger particles were present, then they could become visible and could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions, the company said. Also, reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.
Medicines said it has not received any product complaints or reports of adverse events related to this issue. The company also noted that it is cooperating with the FDA on this recall.