Cubist announced a voluntary recall of certain lots of Cubicin (daptomycin for injection) 500mg/10mL single-use vials to the user level due to potential presence of glass particulate matter in vials. This recall is a result of an issue with a manufacturing line of one of Cubist’s suppliers.
If the glass particulate is administered intravenously, patients may be at risk of a thromboembolism or a life-threatening pulmonary emboli. Other adverse events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, or subsequent generation of microthrombi are also possible. The risk is increased in patients with preexisting trauma or other conditions that affect the microvascular blood supply.
Cubist is notifying customers by letter and phone. Anyone with an existing inventory of the product lots listed should determine whether they have the affected products and arrange for return and replacement. The full list of recalled lots can be found here.
Cubicin is a cyclic lipopeptide antibiotic indicated for susceptible complicated skin and skin structure infections, and S. aureus bacteremia including MRSA and MSSA right-sided endocarditis.
For more information call (855) 534-8309 or visit Cubicin.com.