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FDA Medwatch Alert: Benztropine Mesylate Injection (Nexus Pharmaceuticals): Recall - Visible Particulate Matter

Posted 5 Aug 2013 by

ISSUE: Nexus Pharmaceuticals Inc. is recalling two lots of Benztropine Mesylate Injection, USP, 2 mg/2mL (1mg/mL) in 2 mL single dose vials due to the presence of visible particulate matter in the vials. The product is manufactured by Allergy Laboratories, Inc. and was distributed by Nexus Pharmaceuticals Inc. Affected product includes Lot Numbers 030712, 112911 The administration of particulate, if present in a parenteral drug, poses a safety risk to patients. Sequelae of thromboembolism, some life-threatening (such as pulmonary emboli), may occur. There is also risk for particulates 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. ... Read more

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