Fresenius Kabi USA is recalling four lots of Benztropine Mesylate Injection 2mg/2mL (1mg/mL) due to the potential presence of glass particles in the vials. Benztropine Mesylate Injection is indicated as adjunct therapy in Parkinsonism and in drug-induced extrapyramidal disorders, except tardive dyskinesia.

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If glass particulates present in a parenteral drug are administered to the patient, sequelae of thromboembolism (eg, pulmonary emboli) may occur. Some literature suggests that possible phlebitis and microthrombi generation may occur. In addition, granulomas may form as a local inflammatory response to the foreign material.  

The affected lot numbers are 030712, 071212, 090512, and 111412 supplied in 2mL single-dose vials. Shipment dates range from 5/18/12–05/31/13. The product may appear with “APP” or “Nexus Pharmaceuticals” labels.

Fresenius Kabi USA has discontinued distribution of Benztropine Mesylate Injection during its investigation. All customers who received the recalled vials are being notified and instructed to return any unused product to Fresenius Kabi USA.

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