Benztropine FDA Alerts

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

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. 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.

BACKGROUND: Benztropine Mesylate is used as an adjunct in the therapy of all forms of Parkinsonism. It is useful also in the control of extrapyramidal disorders due to neuroleptic drugs, except tardive dyskinesia. 

RECOMMENDATION: Nexus Pharmaceuticals is notifying its distributors and is arranging for return of all recalled products. Any questions about returning unused products should be directed to the customer call center at 888-806-4606 Monday through Friday, Between the hours of 8 a.m. and 6 p.m. (Central Time). 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[08/01/2013 - Press Release - Nexus Pharmaceuticals Inc] 

Related MedWatch Alert:

[07/02/2013 - Benztropine Mesylate Injection by Fresenius Kabi USA: Recall] 
 

Benztropine Mesylate Injection by Fresenius Kabi USA: Recall - Potential Presence Of Glass Particles

ISSUE: Fresenius Kabi USA is voluntarily recalling four lots of Benztropine Mesylate Injection, USP, 2 mg/2mL (1mg/mL) in 2 mL single dose vials due to the potential presence of glass particles (glass delamination) in the vials. The defect discovered in this product was noted as visible particulate. However, the process of glass delamination may result in formation of visible and subvisible particles. No adverse events, patient reactions or customer complaints have been reported to date.

BACKGROUND: Benztropine Mesylate is used as an adjunct in the therapy of all forms of Parkinsonism. It is also useful in the control of extrapyramidal disorders due to neuroleptic drugs, except tardive dyskinesia. The company has discontinued distribution of Benztropine Mesylate while it investigates the cause. The product is manufactured by Allergy Laboratories, Inc. and distributed by Fresenius Kabi USA. The product may appear with "APP" or "Nexus Pharmaceuticals" labels. Recalled lot numbers include 030712, 071212, 090512 and 111412.

RECOMMENDATION: All customers who received the recalled vials are being notified and instructed to return any unused product to Fresenius Kabi USA. Health care professionals can find additional information by calling Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, between the hours of 8 a.m. and 5 p.m. (Central Time).  Questions regarding product availability and ordering can be directed to Fresenius Kabi USA Customer Service at 1-888-386-1300, Monday through Friday, between the hours of 7 a.m. and 6 p.m. (Central Time).

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[06/30/2013 - Firm Press Release - Fresenius Kabi USA]