Additional lots of clevidipine butyrate injectable emulsion recalled
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Four additional lots of hypertension drug clevidipine butyrate injectable emulsion (Cleviprex) are being recalled because particulate matter has been seen in some vials, the FDA said in a safety notice.
The additional lots being recalled are 68-407-DJ (expires August 2010); 68-408-DJ (expires August 2010); and 71-101-DJ and 71-106-DJ (expire November 2011). Eleven other lots were recalled in December 2009 due to particulate matter that was found to be inert stainless steel particles. If the particles aggregate, or if larger particles are present, they could reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate inflammatory reactions. Ischemia or organ insufficiency could then occur, the notice said.
Affected lots should be returned through the pharmaceutical wholesaler/distributor, the FDA said.