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

[Posted 07/02/2013]

AUDIENCE: Pharmacy, Patient, Health Professional

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 about the recall on the company's web site (www.apppharma.com/our-products/product-updates3) or 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.fda.gov/MedWatch/report.htm
• 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]