Cubist Voluntarily Recalls Nine More Lots of Cubicin
Cubist Pharmaceuticals, Inc. announced on August 8, 2014, is voluntarily recalling nine lots of Cubicin (daptomycin for injection) to the user level following complaints of foreign particulate matter in reconstituted vials. The nine lots are in addition to the lots voluntarily recalled by Cubist in an August 6, 2014 announcement.
Cubicin is an intravenously administered prescription product indicated for the treatment of skin infections and certain bloodstream infections. It is supplied in a single-use vial packaged and was distributed nationwide to multiple consignees.
The affected lots from the most recent August 8, 2014 recall notice may be found here. The affected lots from the August 6, 2014 recall notice may be found here.
Cubist says that to date no reports of adverse events have been associated with product complaints of particulate matter from these lots. In issuing the recall notice of August 6, 2014, Cubist said that the voluntary recall of these lots was as a result of an issue with a manufacturing line of one of its suppliers that could result in glass particulate matter in vials.
​In April 2014, Cubist Pharmaceuticals, Inc. voluntarily recalled one lot of Cubicin to the user level due to the presence of particulate matter, reported via a customer complaint and identified as glass particles, found in a single vial from a lot, produced by a contract manufacturer.
Source: Cubist Pharmaceuticals (August 6, 2014 announcement) and Cubist Pharmaceuticals (August 8, 2014 announcement).