Inspections, Compliance, Enforcement, and Criminal Investigations

January 18, 2019: Medical Company Executive Sentenced for Smuggling $18 Million in Misbranded Pharmaceuticals into United States

   

OCI Small Clear Seal 

 


 

 

 

Food and Drug Administration 
Office of Criminal Investigations

 


 

 

             U.S. Department of Justice Press Release

 

 

For Immediate Release
January 18, 2019

United States Department of Justice

Eastern District of Virginia

ALEXANDRIA, Va. – Tzvi Lexier, of Toronto, Canada, was sentenced today to 26 months in prison for conspiring to smuggle misbranded pharmaceuticals into the United States and for the unlicensed wholesale distribution of prescription drugs.

According to court documents, while he was CEO of TC Medical and SB Medical, Lexier instructed subordinates to smuggle misbranded prescription drugs and devices into the United States, including oncology drugs, orthopedic injections, and cosmetic devices. These products were not approved by the FDA and did not contain the labels, warnings, and instructions required by the FDA. In order to smuggle these products into the United States, TC Medical and SB Medical employees used false names and false customs forms, and broke large shipments into multiple smaller shipments. At Lexier’s direction, co-conspirators in the United States stored TC and SB Medical’s products in their private residences, often in violation of safety regulations requiring the pharmaceuticals to be stored at cool temperatures.

G. Zachary Terwilliger, U.S. Attorney for the Eastern District of Virginia, Mark S. McCormack, Special Agent in Charge, FDA Office of Criminal Investigations, Metro Washington Field Office, Patrick J. Lechleitner, Special Agent in Charge of U.S. Immigration and Customs Enforcement’s (ICE) Homeland Security Investigations (HSI) Washington, D.C., and Peter R. Rendina, Inspector in Charge of the Washington Division of the U.S. Postal Inspection Service, made the announcement after sentencing by U.S. District Judge Anthony J. Trenga. Assistant U.S. Attorneys Jay V. Prabhu, Kellen S. Dwyer, and Nathaniel Smith III prosecuted the case.

 

A copy of this press release is located on the website of the U.S. Attorney’s Office for the Eastern District of Virginia. Related court documents and information is located on the website of the District Court for the Eastern District of Virginia or on PACER by searching for Case No 1:14-cr-397.

 

Topic(s): Health Care Fraud

Component(s): USAO - Virginia, Eastern

Contact: Joshua Stueve Director of Communications joshua.stueve@usdoj.gov

Page Last Updated: 01/31/2019
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English