December 17, 2009
Cleviprex injection recalled due to presence of particulate matter
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.