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News Breaks
August 6, 2014
08:17 EDTCBSTCubist issues voluntary recall of certain lots of CUBICIN in the U.S.
Cubist Pharmaceuticals announced it is voluntarily recalling certain lots of CUBICIN to the user level due to the potential presence of glass particulate matter in vials produced by a contract manufacturer. The administration of a glass particulate, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary emboli. 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 glass particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material. Cubist has decided to issue a voluntary recall of these lots as a result of an issue with a manufacturing line of one of our suppliers that could result in glass particulate matter in vials. No complaints of glass in vial or adverse events in association with a product complaint of glass in vial have been reported to date for these recalled lots.
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September 18, 2014
05:33 EDTCBSTCubist opens international headquarters in Zurich, will invest $400M in R&D
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