Presence of Glass Particulate Matter Causes Cubist to Recall Certain Lots of Cubicin

Cubist Pharmaceuticals, Inc. is voluntarily recalling certain lots of Cubicin (daptomycin for injection) to the user level because of the potential presence of glass particulate matter in vials produced by a contract manufacturer.

Cubist has decided to issue a voluntary recall of certain lots as a result of an issue with a manufacturing line of one of its suppliers that could result in glass particulate matter in vials. No complaints of glass in vial or adverse events in association with a product complaint of glass in vial have been reported to date for the recalled lots.

Cubicin is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections. Cubicin is supplied in a single-use vial packaged in a carton and was distributed nationwide to multiple consignees.

Cubist is notifying customers by letter and phone. Cubist says it wants to ensure that patients and the healthcare professionals using Cubicin are aware of this recall and of what actions, if any, they should take. Cubist is arranging for return of recalled product. An internal investigation has identified the root cause as a manufacturing issue with a single manufacturing line of one of its suppliers, and Cubist has suspended all manufacturing on this line.