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Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter

August 7, 2014

Audience: Pharmacy, Nursing

ISSUE: Cubist Pharmaceuticals, Inc. announced a recall of certain lots of Cubicin (daptomycin for injection) to the user level due to the potential presence of glass particulate matter in vials produced by a contract manufacturer. See the Press Release for a listing of affected lot numbers.

The administration of a glass particulate, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary emboli. Other events such as phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, or subsequent generation of microthrombi are also possible. 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 glass particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material.

BACKGROUND: Cubicin is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. Cubicin was distributed nationwide to multiple consignees.

RECOMMENDATION: Cubist is notifying customers by letter and phone. Anyone with an existing inventory of the product should determine whether they have product from the recalled lots, quarantine and discontinue distribution of the recalled lots of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EDT, Monday through Friday, to arrange for return and replacement of the affected lots.

[08/06/2014 -Press Release - Cubist Pharmaceuticals, Inc.]
[08/07/2014 - Product Labels - FDA]

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