Cubist Pharmaceuticals Voluntarily Recalls One Lot of Cubicin
Cubist Pharmaceuticals, Inc. is voluntarily recalling one lot of Cubicin (daptomycin for injection) to the user level due to the presence of particulate matter, reported via a customer complaint and identified as glass particles, found in a single vial from this lot, produced by a contract manufacturer.
In a statement, the company said that 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 (such as pulmonary emboli), may occur. 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. 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.
No adverse events have been reported to date in association with a product complaint of vials containing glass particulate.
Cubicin is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. Cubicin is supplied in a single-use vial packaged in a carton.
Source: Cubist Pharmaceuticals