Cubist Pharmaceuticals announced that it has issued a voluntary recall of one lot of Cubicin (daptomycin for injection) due to the presence of particulate matter, identified specifically as glass particles.
The recall was triggered by a customer complaint reported to the company. Cubist said the glass particles were found in a single vial from the lot, which was produced by a contract manufacturer. The company said it has suspended all operations on the affected manufacturing line of its contractor.
“Patient safety is Cubist’s top priority and the company 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 our suppliers, and Cubist has suspended all manufacturing on this line,” the company stated in its press release.
Cubicin is an intravenously administered prescription product approved and indicated for the treatment of skin infections and certain blood stream infections. The drug is supplied in a single-use vial. The affected lot is 500 mg, Lot # 280453F, expiration date: April 2016. Careful visual inspection for particulate matter is advised before administration of parenteral drug products such as Cubicin.
Administration of glass particulate may lead to sequelae of thromboembolism, phlebitis, mechanical block of the capillaries or arterioles, and activation of platelets. Subsequent generation of microthrombi and emboli may also occur.
No adverse events have been reported as of yet. Users as well as healthcare professionals and pharmacists are encouraged to report any quality problems or adverse events experienced with the affected products. The company said the recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).