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April 18, 2014
13:32 EDTCBSTCubist announces voluntarily recalling one Cubicin lot
Cubist Pharmaceuticals announced it is voluntarily recalling one lot of Cubicin to the user level due to the presence of particulate matter, reported via customer complaint and identified as glass particles, found in a single vial from this lot, produced by a contract manufacturer. The administration of glass particulate, if present in an intravenous drug, poses a potential safety risk to patients. Case reports suggest that sequelae of thromboembolism, some life-threatening, may occur, the company said. There have also been reports in the literature of particulate possibly causing phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. No adverse events have been reported to date in association with a product complaint of vials containing glass particulate.
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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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