Cubist Pharmaceuticals announced that it is voluntarily recalling four lots of Cubicin (daptomycin for injection) to the user level due to the presence of particulate matter found in a number of vials from these lots, Cubist announced in a press release.
The lots of 500-mg Cubicin in 10-mL, single-use vials were shipped between May 2011 and March 2013. An internal investigation has preliminarily identified the root cause as a manufacturing issue with a supplier, and Cubist has suspended all manufacturing with the supplier until corrective and preventative measures have been taken.
Cubist is notifying customers by letter and phone and notes that existing inventory should be checked. Cubist is arranging for return of recalled product. Glass particulate in an intravenous drug poses a potential safety risk to patients, but no adverse events related to the recall have been reported to date.