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Cubicin (daptomycin for injection): Recall - Glass Particulate Matter Present in Four Lots
AUDIENCE: Health Professional, Pharmacy
ISSUE: Cubist has notified customers by letter and phone of the voluntary recall of four lots of Cubicin (daptomycin for injection) due to the presence of particulate matter found in a number of vials from four lots shipped from May 2011 to March 2013.
BACKGROUND: 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. 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.
RECOMMENDATION: Anyone with an existing inventory of the product lots listed in the firm's press release 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.
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.
Read the complete MedWatch Safety Alert, including a link to the Firm Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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