Nexus Pharmaceuticals announced a recall of Benztropine Mesylate Injection 2mg/2mL (manufactured by Allergy Laboratories) due to the presence of visible particulate matter in the vials. Benztropine Mesylate Injection is indicated as adjunct therapy in Parkinsonism and in drug-induced extrapyramidal disorders, except tardive dyskinesia.
The affected product includes Lot #030712 and 112911 and is supplied in 2mL single-dose vials. If particulate matter is administered parenterally, sequelae of thromboembolism or pulmonary emboli may occur. There is also an increased risk of phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Further, administration of a particulate can lead to the granuloma formation that is typically non-serious.
Nexus Pharmaceuticals is notifying its distributors and is arranging for return of all recalled products.
For more information call (888) 806-4606 or visit FDA.gov.