Particulate Matter Found in Cubicin Vial

Cubist Pharmaceuticals announced a voluntary recall of one lot of Cubicin (daptomycin for injection) 500mg in 10mL vials, following a consumer complaint of particulate matter. Cubist identified the matter as glass particles found in a single vial from the lot, produced by a contract manufacturer.

Cubicin is an intravenous antibiotic indicated for susceptible complicated skin and skin structure infections (cSSSI), S. aureus bacteremia including MRSA, and MSSA right-sided endocarditis.

The affected lot number is 280453F, which has an expiration date of April 2016; this product was shipped to consumers between 3/17/2014 and 3/25/2014. Cubist is notifying customers via letter and phone. Anyone with existing inventory of the product should discontinue distribution of this lot and notify Cubist.

The intravenous administration of glass particulate matter may result in possibly fatal thromboembolism (eg, pulmonary emboli), phlebitis, mechanical block of capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli.

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