Friday, August 30, 2013

Cubist Pharmaceuticals Issues Voluntary Nationwide Recall

LEXINGTON, Mass.--(BUSINESS WIRE)--August 29, 2013-- 
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it is voluntarily recalling four lots of CUBICIN(R) (daptomycin for injection) to the user level due to the presence of particulate matter found in a number of vials from these lots.
Product Description  Lot #    Expiration Date  First Ship Date  Last Ship Date 
CUBICIN(R)           950453F  12/06/2013       05/31/2011       06/27/2011 
(daptomycin for 
injection) 500 mg 
NDC 67919-011-01 
                     090203F  09/07/2014       01/12/2012       01/23/2012 
                     201703F  08/31/2015       03/4/2013        03/7/2013 
                     201653F  09/01/2015       03/12/2013       03/18/2013 
No adverse events have been reported to date in association with a product complaint of vials containing glass particulates.

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

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.

Patient safety is Cubist's top priority and the Company wants to ensure that patients and the healthcare professionals using CUBICIN are aware of this recall and of what actions, if any, they should take. Cubist is arranging for return of recalled product. An internal investigation has preliminarily identified the root cause as a manufacturing issue with one of our suppliers. Cubist has suspended all manufacturing with the supplier until corrective and preventative measures have been taken.
For healthcare professionals and pharmacists with questions regarding this recall may contact Cubist Medical Information at (877) 282-4786 between the hours of 8 a.m. to 5:30 p.m. EST, Monday through Friday.

Adverse events or quality problems experienced with the use of this product may also be reported to the U.S. Food and Drug Administration's (FDA) MedWatch Adverse Events Program either online, by regular mail or by fax.

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