Voluntarily recall of daptomycin for injection due to presence of glass particles


FAD report “Cubist Pharmaceuticals, Inc. is voluntarily recalling one lot (Lot # 280453F) of CUBICIN (daptomycin for injection) 500 mg to the user level due to the presence of particulate matter, identified as glass particles.

The administration of glass particulate, if present in an intravenous drug, poses a potential safety risk to patients including: thromboembolism, pulmonary emboli, phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Patients with 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.”

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