The FDA and The Medicines Company have notified healthcare professionals of a voluntary nationwide recall of 11 lots of Cleviprex (clevidipine butyrate) injection emulsion 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 following lots are being recalled:
- 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
- 64-453-DJ; Exp. 04/2011
Cleviprex 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.