Biopharmaceutical firm Cubist Pharmaceuticals is voluntarily recalling four lots of Cubicin (daptomycin for injection) 500mg in 50ml single use vials in the US primarily due to presence of glass particulates.
The company said that no adverse events have been reported so far due to contamination.
Cubist said that patients administered with a cubicin injection containing glass particulates will have risk of diseases like pulmonary emboli, phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, and subsequent generation of microthrombi.
Moreover, the risk will increase in patients with preexisting condition of trauma or other medical condition that affects the microvascular blood supply. Administration of a glass particulate can also lead to formation of granulomas.
The cubicin package insert comes with a warning that parenteral drug products should be carefully inspected visually for particulate matter prior to administration.
Meanwhile, the company has suspended all manufacturing with the supplier until preventative measures have been taken.
