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Cubist Pharmaceuticals recalls lots of Cubicin
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Cubist Pharmaceuticals voluntarily recalled nine lots of daptomycin for injection because of foreign particulate matter found in reconstituted vials, according to a press release from the manufacturer.
The nine lots of Cubicin 500 mg in 10 mL single-use vials were shipped nationwide between September and December 2013 and have expiration dates that vary from December 2015 through July 2016.
The administration of particulate matter, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism. Other events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets or subsequent generation of microthrombi are also possible, according to the manufacturer.
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 particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material.
To date, no reports of adverse events have been associated with product complaints of particulate matter from these lots, according to Cubist.
Daptomycin for injection is indicated for the treatment of complicated skin and skin structure infections and Staphylococcus aureus bloodstream infections, including those with right-sided infective endocarditis, caused by susceptible strains of microorganisms.
Go to www.fda.gov/Safety/Recalls for more information and affected lot numbers.