The Food and Drug Administration (FDA) is expanding a recall on Ceviprex (clevidipine butyrate) injectable emulsion originally announced in December 2009 to include four additional lots. All 15 lots of Ceviprex may be contaminated with particulate matter identified inert stainless steel particles. According to the FDA, if these particles aggregate or if larger particles are present, then they 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 or lungs.
Ceviprex is an injectable medication known as a calcium channel blocker that widens blood vessels and improves blood flow. It is used in hospitals or medical offices to rapidly reduce blood pressure and maintain blood pressure control. The particulate matter was initially found during a routine inspection at the Medicines Co. plant in Parsippany, N.J.
Health care professionals should check their inventory for affected lots of Ceviprex and arrange for the return of any recalled lots through their pharmaceutical wholesaler or distributor. Medical inquiries, adverse events reporting or quality issues with this drug can be directed to The Medicines Company at email@example.com. Any adverse events with this or any other medication should be reported to the FDA MedWatch Adverse Events Reporting program at www.FDA.gov/MedWatch.