Cubist Pharmaceuticals, Inc. (CBST) Issues Voluntary Nationwide Recall Of Nine Lots Of CUBICIN (Daptomycin For Injection) 500 Mg In 10 Ml Single Use Vials Following Complaints Of Foreign Particulate Matter In Reconstituted Vials
8/11/2014 8:45:54 AM
LEXINGTON, Mass.--(BUSINESS WIRE)--Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it is voluntarily recalling nine lots of CUBICIN® (daptomycin for injection) to the user level following complaints of foreign particulate matter in reconstituted vials.
The administration of particulate matter, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism. Other events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets or subsequent generation of microthrombi are also possible. Patients with a preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material. To date, no reports of adverse events have been associated with product complaints of particulate matter from these lots.
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