FDA MedWatch - CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Foreign Particulate Matter
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CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Foreign Particulate Matter
*AUDIENCE:* Risk Manager, Health Professional, Pharmacy, Nursing
*ISSUE:* Cubist Pharmaceuticals, Inc.is voluntarily recalling nine lots of CUBICIN (daptomycin for injection) to the user level following complaints of foreign particulate matter in reconstituted vials. Refer to the Press Release [ http://www.fda.gov/Safety/Recalls/ucm408928.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ] for a list of affected products.
The administration of particulate matter, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism. 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 particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material. To date, no reports of adverse events have been associated with product complaints of particulate matter from these lots.
*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:* 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 these 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm [ http://www.fda.gov/MedWatch/report.htm?source=govdelivery&utm_medium=email&utm_source=govdeliverywww.fda.gov/MedWatch/report.htm [ http://www.fda.gov/MedWatch/report.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ]
* Download form [ http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ] or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including links to the Press Release at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm408934.htm [ http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm408934.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery ]