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Cubist Pharmaceuticals issues voluntary nationwide recall of one lot of Cubicin due to presence of particulate matter
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 customer complaint and identified as glass particles, found in a single vial from this lot, produced by a contract manufacturer.
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 (refer to www.cubicin.com). The affected Cubicin lot information is contained in the table below. Cubicin was distributed nationwide.
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.
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No adverse events have been reported to date in association with a product complaint of vials containing glass particulate.
Cubist is notifying customers by letter and phone. Anyone with an existing inventory of the product lot listed should determine whether they have product from the recalled lot, quarantine and discontinue distribution of this recalled lot of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EDT, Monday through Friday, to arrange for return and replacement of the affected lot.