Medicines Issues Nationwide Recall For Certain Lots Of Cleviprex

The Medicines has reported that it is voluntarily recalling eleven lots of Cleviprex (clevidipine butyrate) injectable emulsion 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 that are recalled by the company 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.

The company said that it has not received any product complaints or reports of adverse events related to this issue and is cooperating with the FDA on this recall.

The company claims that particulate matter comprises of sub-visible inert stainless steel particles of around 2.5 microns. When present in low numbers as observed, 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.

The company said that anyone with inventory from the affected lots of Cleviprex should arrange for its return through their pharmaceutical wholesaler/distributor. Unaffected product from lots 68-407-DJ, 68-408-DJ, 71-101-DJ and 71-106-DJ is being shipped to wholesalers and can be ordered by hospitals.