Product alert: Nexus Pharmaceuticals Inc. is recalling two lots of Benztropine Mesylate Injection

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Intravenous products: FDA report “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. Administration of a particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material and are typically non-serious.”

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