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Cubist Pharmaceuticals Recalls One Lot of CUBICIN 500 mg in 10 mL Single Use Vials

Fri, 04/18/2014 - 2:45pm

Cubist Pharmaceuticals is voluntarily recalling one lot of CUBICIN® (daptomycin for injection) to the user level due to the presence of particulate matter, reported via customer complaint and identified as glass particles, found in a single vial from this lot, produced by a contract manufacturer.

The administration of glass particulate, if present in an intravenous drug, poses a potential safety risk to patients. Case reports suggest that sequelae of thromboembolism, some life-threatening (such as pulmonary emboli), may occur. There have also been reports in the literature of particulate possibly causing phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Patients with 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.

No adverse events have been reported to date in association with a product complaint of vials containing glass particulate.

Cubicin is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. Cubicin is supplied in a single-use vial packaged in a carton (refer to www.cubicin.com). The affected Cubicin lot information is contained in the table below. Cubicin was distributed Nationwide to multiple consignees.
                                                                 
Product Description                 Lot #                 Expiration Date                 Ship Dates (MM/DD/YYYY)

CUBICIN® (daptomycin for injection)

500 mg

 

NDC 67919-011-01; UPC 3 67919-011-01 6
                280453F                 APR 2016                 3/17/2014 through 3/25/2014
                                                 

Cubist is notifying customers by letter and phone. Anyone with an existing inventory of the product lot listed should determine whether they have product from the recalled lot, quarantine and discontinue distribution of this recalled lot 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 lot.

As noted in the package insert for CUBICIN, parenteral drug products should be carefully inspected visually for particulate matter prior to administration. Healthcare providers should not use any CUBICIN vials containing particulate matter.

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