BETHESDA, MD 29 Aug 2013—Lexington, Massachusetts-based Cubist Pharmaceuticals today announced the recall of four lots of daptomycin for injection because glass particles have been found in some of the vials.
The recalled vials are from lot 950453F, which has an expiration date of December 6, 2013, and was shipped to customers May 31–June 27, 2011; lot 090203F (expiration date September 7, 2014, shipped January 1–23, 2012); lot 201703F (expiration date August 31, 2015, shipped March 4–7, 2013); and lot 201653F (expiration date September 1, 2015, shipped March 12–18, 2013).
Anyone who has recalled vials in inventory should quarantine them and contact Cubist at 855-534-8309 between 9:00 am and 7:00 pm Eastern Standard Time, Monday through Friday, to arrange for product return and replacement. Questions about the recall should be addressed to Cubist Medical Information at 877-282-4786 between 8:00 am and 5:30 pm Eastern Standard Time, Monday through Friday.
The company cited a "manufacturing issue" with a supplier as the preliminary root cause of the problem.
No adverse events related to the presence of particulates in these vials have been reported to the company, but the i.v. administration of glass particles poses a potential safety risk for patients.
The company reminded customers to always visually inspect each vial of daptomycin before administering the drug to a patient.