FDA is reporting that Cubist Pharmaceuticals has announced it 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. The company states it has decided to issue a voluntary recall of these lots as a result of an issue with a manufacturing line of one of their suppliers that could result in glass particulate matter in vials.
An internal investigation has identified the root cause as a manufacturing issue with a single manufacturing line of one of the company’s suppliers, and Cubist has suspended all manufacturing on this line. According to the company, however, 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. Information on the affected lots can be found on the company’s website.
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.
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. CUBICIN was distributed nationwide to multiple consignees.
The company is notifying customers by letter and phone. Anyone with an existing inventory of the product lots listed in the recall should determine whether they have product from the recalled lots, quarantine, and discontinue distribution of this recalled lots 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 lots.