March 18, 2010
The Medicines Company expands Cleviprex recallThe FDA and The Medicines Company have notified healthcare professionals of an additional recall of 4 lots of Cleviprex (clevidipine butyrate injectable emulsion). This expands the December 2009 recall to include a total of 15 lots of Cleviprex. These lots are being recalled due to the presence of visible particulate matter observed in some vials. The particulate matter comprises sub-visible inert stainless steal particles of approximately 2.5microns. When present in low numbers as observed, particles of this size are not known to constitute a health hazard.
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. Reduced blood supply to tissues may lead to ischemia or organ insufficiency in the brain, kidney, liver, heart or lungs.
The four additional recalled 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
Cleviprex, an IV calcium channel blocker, is indicated for the reduction of blood pressure when oral therapy is not feasible or desirable.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm194585.htm.