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Category: Safety and Recalls

Recalls and Safety

February 21, 2018: Pharmacy Tech Sentenced to Five Years in Prison for Tampering with Opioids for IV Fluid

 

  Food & Drug Administration Office of Criminal Investigations  

BIRMINGHAM – A federal judge today sentenced a former lead technician at a central Alabama pharmacy to five years in prison for tampering with vials of opioid painkillers used in the compounding of intravenous fluid bags intended for terminally ill patients in debilitating pain.
 U.S. Attorney Jay E. Town, Drug Enforcement Administration Assistant Special Agent in Charge Bret Hamilton & Food & Drug Administration, Office of Criminal Investigations, Acting Special Agent in Charge Peter Kuehl announced the sentence.
U.S. District Judge R. David Proctor sentenced JOHNATHON WILLIAM CLICK , 30, of Bessemer, on one-count of tampering with consumer products in reckless disregard for the risk that another person would be placed in danger of death or bodily injury, & under circumstances manifesting extreme indifference to that risk. Click pleaded guilty to the charge in November.
“Jonathan Click knew he was inflicting untold pain & suffering on terminally ill cancer patients, yet for two years he diluted their medication and took the opioid drugs for himself,” U.S. Attorney Town said. “Mr. Click is going to prison for his crime, & he will be joined shortly by those like him.”  
“Patients deserve to have confidence that they are receiving the proper treatment from those entrusted with providing their medical care,” said FDA Acting Special Agent in Charge Kuehl. “That’s why we must hold medical personnel accountable when they take advantage of their unique position & tamper with drugs needed by their patients, especially when such tampering…

February 20, 2018: U.S. Attorney Announces 69-count Indictment Charging Owners, Managers & Physicians Associated with Hope Clinic

 

  Food & Drug Administration Office of Criminal Investigations  

United States Attorney Mike Stuart announced the unsealing of a 69-count indictment charging a total of 12 individuals with operating a “pill mill.”  The indictment charges the owners, managers & physicians associated with HOPE Clinic, which operated as a purported pain management clinic in Beckley, Beaver and Charleston, West Virginia, as well as Wytheville, Virginia, and a related company, with conspiring to distribute oxycodone & other Schedule II controlled substances, not for legitimate medical purposes and outside the usual course of professional practice, from November 2010 to June 2015.   
United States Attorney Mike Stuart was joined in the announcement by Special Agent in Charge Maureen Dixon, U.S. Department of Health & Human Services, Office of Inspector General (HHS-OIG), Philadelphia Regional Office & Assistant Special Agent in Charge Sherri Arp, Internal Revenue Service Criminal Investigations (IRS CI), Washington, D.C. Field Office.  “I commend the work of my team, under the leadership of AUSAs Monica Coleman & Meredith Thomas & the critical work of our law enforcement partners,” said United States Attorney Mike Stuart.  Stuart commended the investigation conducted by agents with:
·       U.S. Dept. of Health and Human Services, OIG
·       Internal Revenue Service, Criminal Investigations
·       Food and Drug Administration – Office of Criminal Investigations (OCI)
·       Federal Bureau of Inquiry
·       Drug Enforcement Administration
·       West Virginia State Police
·       Metropolitan Drug Enforcement Network Team (MDENT)
·       Beckley Police Department
·       Kentucky State Police
·       Harrison County (KY) Sheriff’s Department
·       Appalachia HIDTA The charges announced today aggressively target medical professionals…

February 14, 2018: Palmer Man Sentenced for Conspiring to Import Prescription Drugs from Pakistan

 

  Food & Drug Administration Office of Criminal Investigations  

BOSTON – A Palmer man was sentenced for conspiring to import prescription drugs from Pakistan.
Harry Aliengena, 65, was sentenced by U.S. District Court Judge Mark G. Mastroianni to two years in prison and three years of supervised release. In November 2017, Aliengena pleaded guilty to one count of conspiracy to import controlled substances, two counts of felony introduction of misbranded drugs with intent to defraud or mislead, & one count of misdemeanor introduction of misbranded drugs.
Between July 2011 & June 2012, Aliengena conspired to import prescription drugs from Pakistan into the United States & distributed misbranded drugs to U.S. customers. Aliengena communicated regularly with a Pakistani company & ordered various drugs – including Ritalin, Percocet, Hydrocodone, Adderall, & Restoril – all DEA controlled substances. Aliengena then reshipped a portion of these drugs to customers in the United States on behalf of the Pakistani company in return for payments & discounts on drugs for his personal use.
United States Attorney Andrew E. Lelling; Jeffrey Ebersole, Special Agent in Charge of the Food & Drug Administration, Office of Criminal Investigations, New York Field Office; & Michael Shea, Acting Special Agent in Charge of Homeland Security Investigations in Boston, made the announcement. Assistant U.S. Attorney Deepika Bains Shukla of Lelling’s Springfield Branch Office prosecuted the case.
 
Topic(s): 
Drug Trafficking
Opioids
Prescription Drugs
 
Component(s): 
USAO – Massachusetts
  …

February 14, 2018: Two Indian Citizens & India-based Corporation Sentenced for Conspiring to Smuggle Counterfeit Cigarettes

 

  Food & Drug Administration Office of Criminal Investigations  

Abhishek Shukla & Harish Shabhai Panchal, both citizens of India, along with the India-based company, Jubilee Tobacco Industries Corp., were sentenced in federal District Court in Miami, for conspiring to smuggle counterfeit cigarettes into the United States.  
Benjamin G. Greenberg, United States Attorney for the Southern District of Florida, Peter H. Kuehl, Acting Special Agent in Charge, U.S. Food & Drug Administration, Office of Criminal Investigations (FDA-OCI), Miami Field Office, Mark Selby, Special Agent in Charge, U.S. Immigration & Customs Enforcement’s Homeland Security Investigations (ICE-HSI), Miami Field Office, & Scott Israel, Sheriff, Broward County Sheriff’s Office (BSO), made the announcement. 
 
U.S. District Judge Kathleen M. Williams sentenced each of Shukla and Panchal to 23 months imprisonment, to be followed by supervised release for two years.  Judge Williams sentenced Jubilee to corporate probation of two years & ordered Jubilee to forfeit $300,000 to the United States.
 
All three defendants previously pled guilty to conspiring with each other, with the intent to defraud & mislead, sell & cause the sale & dispensing of a counterfeit tobacco product (cigarettes), the containers & labeling of which bore the trade name & marks of the American brand of Newport cigarettes, a tobacco product listed with the FDA pursuant to Title 21, United States Code, Section 387(e)(I will)(1), (approximately 68,600 cartons of cigarettes), while knowingly using a counterfeit mark on & in connection with such cigarettes, the use of which marks was likely to cause confusion, to cause mistake, & to…

February 9, 2018: Tampa Resident Convicted for Involvement with Tricare Health Care Fraud Scheme

 

  Food & Drug Administration Office of Criminal Investigations  

Benjamin G. Greenberg, United States Attorney for the Southern District of Florida, John F. Khin, Special Agent in Charge, Defense Criminal Investigative Services (DCIS), Southeast Field Office, Peter H. Kuehl, Acting Special Agent in Charge, U.S. Food & Drug Administration’s Office of Criminal Investigations (FDA-OCI), Miami Field Office, & Frank Robey, Director, U.S. Army Criminal Investigation Command’s Major Procurement Fraud Unit, made the announcement. 
On February 5, 2018, a federal jury in Miami unanimously convicted Monty Ray Grow, 46, on 18 criminal counts including conspiracy to commit health care fraud, in violation of 18 U.S.C. § 1347; conspiracy to pay & receive health care kickbacks, in violation of 18 U.S.C. § 371; unlawful receipt of health care kickbacks, in violation of 42 U.S.C. § 1320a-7(b)(1)(A); and money laundering, in violation of 18 U.S.C. § 1957. 
Evidence presented at trial established that during an 8-month span in 2014-15, Grow participated in a scheme to defraud the Tricare program out of tens of millions of dollars. Tricare is the health care program for the U.S. military that pays the health care costs of active & retired military personnel & their families. That insurance benefit includes paying for any medications that a Tricare beneficiary needs.  Grow enticed Tricare beneficiaries to order very expensive drugs that they did not need. Tricare, not the patients, paid the bill for these expensive drugs and the pharmacy split 50% of the profits with Grow.  Evidence at trial established that Grow targeted Tricare beneficiaries & induced…

February 8, 2018: Queensbury Oncologist & Spouse to Pay $500,000 for Submitting False Claims to Medicare for the Administration of Unapproved Cancer Drugs

 

  Food & Drug Administration Office of Criminal Investigations  

ALBANY, NEW YORK – Dr. Vincent Koh & his wife and office manager, Milly Koh, have agreed to pay $500,000 for violating the False Claims Act by knowingly submitting false claims to Medicare for unapproved chemotherapy drugs, announced United States Attorney Grant C. Jaquith.  On November 20, 2017, the Kohs pled guilty to receiving & delivering misbranded drugs, a misdemeanor, and are scheduled to be sentenced on March 20, 2018 by United States Magistrate Judge Daniel J. Stewart.  
The Kohs own & operate a medical practice, with offices in Poughkeepsie & Glens Falls, New York, that specializes in the treatment of patients suffering from various forms of cancer.  From mid-2010 to early 2012, the practice purchased various drugs purporting to contain the same active ingredients as drugs sold in the United States from a Canadian drug distributor who had obtained these drugs from foreign sources.  The drugs, some of which contained labeling in foreign languages, were not approved by the U.S. Food and Drug Administration (FDA) as required for them to be distributed in the United States & were therefore not reimbursable by Medicare.
Dr. Koh’s practice purchased the foreign drugs at substantially lower prices than those charged for drugs from legitimate U.S. drug manufacturers & distributors.  Dr. Koh administered these drugs to his patients, & caused his staff to submit false claims for the drugs to Medicare.
“Unlike prescription drugs picked up at a pharmacy, chemotherapeutic drugs generally are administered without any opportunity…

February 5, 2018: Pennsylvania Firearms Dealer Sentenced To 100 Months Imprisonment

 

  Food & Drug Administration Office of Criminal Investigations  

Hammond – The United States Attorney for the Northern District of Indiana, Thomas L. Kirsch II, announced that Vahan Kelerchian, 58, of Richboro, Pennsylvania, doing business as Armament Services International “ASI,” was sentenced before Elder District Court Judge Joseph S. Van Bokkelen for his role in the acquisition of machineguns & restricted laser aiming sights.
Kelerchian was sentenced to 100 months imprisonment, ordered to pay a $100,000 fine & $28,200 in restitution along with serving 1 year of supervised release upon release from prison.  Kelerchian was found guilty after a two-week trial that ended October 15, 2016.  Kelerchian was taken into custody upon sentencing to begin serving his sentence. 
According to evidence presented at trial, Kelerchian conspired with Joseph Kumstar & Ronald Slusser, now former Lake County Police Officers, to knowingly make false statements relating to the acquisition of firearms.  Kumstar & Slusser, who have plead guilty, used their positions as sworn law enforcement officers in coordination with Kelerchian using his position as a Class 3 Federal Firearms Licensee to acquire approximately 71 fully automatic machineguns in the name of the Lake County Sheriff’s Dept. knowing that the Lake County Sheriff’s Dept. was not going to be the true owner of these weapons.  Kelerchian, Kumstar & Slusser conspired to use law enforcement letter head to create letters which falsely represented that the machineguns were going to be used by the Lake County Sheriff’s Department to carry out its law enforcement responsibilities since machineguns…

February 5, 2018: Three Florida Residents Sentenced for Operating an Illegal Steroid & Counterfeit Prescription Drug Lab

 

  Food & Drug Administration Office of Criminal Investigations  

Montgomery, Alabama — Three Chipley, Florida, residents were sentenced yesterday to serve time in federal prison for their involvement in a steroid & counterfeit prescription drug lab in Northwest Florida, announced Louis V. Franklin, Sr., United States Attorney for the Middle District of Alabama.
Ryan Anthony Sikora (24) was sentenced to 41 months in prison, Ariel Anna Murphy (29) to 12 months, & John Joseph Bush, II (26) was sentenced to 8 months. The three received their ces after pleading guilty to conspiracy charges for importing, manufacturing, & distributing anabolic steroids as well as counterfeit prescription drugs.
The investigation began when United States Postal Inspectors determined that large amounts of steroid & counterfeit prescription drug ingredients were being shipped from China to various locations in South Alabama and Northwest Florida. the defendants mass-produced counterfeit pills at a lab near Chipley, Florida, using two large-scale pill presses. They marketed the counterfeit drugs online using the brand name “Future Pharma” and they would typically process the orders through encrypted email, & then use the United States Postal Service to send the contraband products across the United States.
U.S. Attorney Franklin would like to thank the following agencies for their assistance with this case: The United States Postal Inspection Service, the United States Food & Drug Administration (FDA) Office of Criminal Investigations, the Alabama Law Enforcement Agency (ALEA), the Florida Department of Law Enforcement (FDLE), the Washington County (Florida) Sheriff’s Office, & the Chipley, Florida, Police Dept.. This…

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