Cubist Pharmaceuticals Voluntarily Recalls Lots of Cubicin Due to Supplier’s Glass Particulate Matter
Cubist Pharmaceuticals Inc. is voluntarily recalling certain lots of Cubicin (daptomycin for injection) to the user level due to the potential presence of glass particulate matter in vials produced by a contract manufacturer. Cubicin is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. It is supplied in a single-use vial packaged in a carton. It was distributed nationwide to multiple consignees
Cubist has decided to issue a voluntary recall of these lots as a result of an issue with a manufacturing line of one of its 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, according to the company.
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.
In April 2014, Cubist Pharmaceuticals, Inc. voluntarily recalled one lot of Cubicin 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 a lot, produced by a contract manufacturer.
Source: Cubist Pharmaceuticals