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Cubist Pharma Recalls One Lot Of Cubicin Due To Presence Of Particulate Matter

Cubist Pharmaceuticals, Inc. (CBST) said Friday that it is voluntarily recalling one lot of Cubicin to the user level due to the presence of particulate matter, reported through customer complaint and identified as glass particles, found in a single vial from that lot, produced by a contract manufacturer.

The affected Cubicin lot was shipped between March 17 trough March 25.

Cubicin is an intravenously administered prescription product indicated for the treatment of skin infections and certain blood stream infections.

The administration of glass particulate, if present in an intravenous drug, poses a potential safety risk to patients. Case reports suggest that sequelae of thromboembolism, some life-threatening, may occur. There have also been reports in the literature of particulate possibly causing phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk.

No adverse events have been reported to date in association with a product complaint of vials containing glass particulate, the company said.

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