Presence of glass particles has been reported through customer complaint. Administration of glass particulate, if present in an intravenous drug, poses a potential safety risk to patients.
Case reports suggest that administration of glass particulate may lead to sequelae of thromboembolism, some life-threatening (such as pulmonary emboli). 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.
Glass particulate injection can also result in the formation of granulomas that represent a protective local inflammatory response to the foreign material. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk.
As of now, no adverse events have been reported in association with a product complaint of vials containing glass particulate.
According to Cubist, an internal investigation has identified the root cause as a manufacturing issue with a single manufacturing line of one of the company’s suppliers. The company has stopped all manufacturing on this line and is arranging for return of recalled product.
Cubicin, an intravenously administered prescription product, is indicated for the treatment of skin infections and certain blood stream infections.