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Category: Safety and Recalls

Recalls and Safety

June 5, 2018: Opioid Prescription Conspiracy Leader Pleads Guilty

 

  Food & Drug Administration Office of Criminal Investigations  

PROVIDENCE, RI – A Providence man who led a conspiracy to create fraudulent prescriptions for opioid pills using stolen medical practitioner identification numbers and identities, &, at times, unlawfully paying for the prescriptions with the use of medical insurance, has pleaded guilty in U.S. District Court in Providence to conspiracy to distribute and possess with the intent to distribute Oxycodone, and aggravated identity theft.
Robert Rose, 52, the acknowledged leader of the conspiracy, is the fourth person to plead guilty for their role in the conspiracy, announced United States Attorney Stephen G. Dambruch & Jeffrey Ebersole Resident Agent in Charge of the United States Food & Drug Administration Office of Criminal Investigations.
 
A fifth defendant charged in this matter is awaiting trial in U.S. District Court.
 
According to court documents, it was the intent of the conspiracy to manufacture fraudulent prescriptions utilizing the identities & Drug Enforcement Administration (DEA) identification numbers and signatures of medical practitioners without their consent. Prescriptions for varying amounts of Oxycodone pills were written & presented to pharmacies by some members of the conspiracy and others working at the direction of the conspirators. The scheme often times included the fraudulent use of medical insurance to pay pharmacies for the illicit prescriptions. Most of the Oxycodone pills gained with the use of fraudulent prescriptions were sold to other people for distribution.
 
At the time of his guilty plea, Robert Rose admitted to the Court that as the leader of the conspiracy, he…

January 10, 2018: Six Charged in Complex Fraud Involving Fraudulent Processing of Credit Card Payments

 

  Food and Drug Administration Office of Criminal Investigations  

PITTSBURGH – Six residents of New York, were indicted by a federal grand jury in Pittsburgh & arrested on a charges of conspiracy to commit mail fraud, phone fraud, & bank fraud, United States Attorney Scott W. Brady announced today.
 
A one-count indictment, returned in December 2017, named Devan Abrams, 37, of New York, NY, Tamara Feldman, 29, of Brooklyn, NY, Azad Khizgilov, 43, of Staten Island, NY, & Roman Shaulov, age 50, of Brooklyn, NY. Separate one-count indictments named Philip Krasnikov, 31, of Brooklyn, NY & Svetlana Kapralova, 30, of Brooklyn, NY.
 
According to the indictments presented to the court, the conspirators were involved in a complex fraud that involved fraudulently processing credit card payments. The credit card companies will not allow their products & services to be used to pay for certain precluded activities, including the on-line sales of pharmaceutical drugs and of products violating trademark infringement laws. The defendants participated in the conspiracy designed to conceal from the credit card companies the fact they used their products & services to pay for precluded activities & to subvert the internal controls the credit card companies had in place to detect & prevent this type of activity. The fraud involved establishing shell corporations & web sites associated with the shell companies that falsely claimed that they sold products other than pharmaceutical drugs or products that violated trademark infringement laws. The conspirators then applied for merchant accounts from the credit card companies in…

May 31, 2018: Two Suburban Chicago Residents Charged with Illegally Selling Narcotics Over the Internet; Law Enforcement Seizes Websites

 

  Food & Drug Administration Office of Criminal Investigations  

CHICAGO — Two suburban Chicago residents have been charged with federal drug offenses for illegally selling fentanyl or fentanyl precursors over the internet, & authorities have seized their websites.
 
LIANGFU “LARRY” HUANG used his company, Ark Pharm Inc., to sell controlled substances – including a fentanyl precursor – over the internet, despite not registering with federal or state authorities, according to a criminal complaint & affidavit filed in federal court in Chicago.  Ark Pharm, which is based in Arlington Heights, Ill., offered various drugs for sale on its website (http://www.arkpharminc.com (link is external)).  Huang, 53, of Northbrook, Ill., was arrested Wednesday night after arriving at O’Hare International Airport in Chicago on a flight from China.  He is charged with one count of conspiracy to knowingly & intentionally possess with intent to distribute, and to distribute, a controlled substance.
 
In a related case, WEI XU, also known as “Scarlett Hsu,” used her company, 1717 CheMall Corp., to illegally sell fentanyl & other controlled substances without registering with federal or state authorities, according to the complaint against her.  1717 CheMall Corp., which is based in Mundelein, Ill., offered various drugs for sale on its website (http://www.1717chem.com (link is external)), including the opioids ocfentanil, oxycodone and hydrocodone, the complaint states.  Visitors to the website could search for a drug and order it from the site’s “estore,” the complaint states.  Xu, 52, of Vernon Hills, Ill., was arrested Wednesday.  She is charged with one count of knowingly…

June 5, 2018: Floridian Charged in Complex Fraud Scheme Related to the Processing of Credit Card Payments

 

  Food & Drug Administration Office of Criminal Investigations  

PITTSBURGH, Pa. – A resident of Boca Raton, Florida, has been indicted by a federal grand jury in Pittsburgh on a charge of conspiracy to commit mail, cellphone & bank fraud, United States Attorney Scott W. Brady announced today.
The one-count indictment, returned on May 1, 2018, named Gennady Nudelman, 42, as the sole defendant. Nudelman was arrested today & the indictment unsealed.
According to the indictment, Nudelman was involved in a complex conspiracy related to the fraudulent processing of credit card payments. The credit card companies will not allow their products and services to be used to pay for certain precluded activities, including the on-line sales of pharmaceutical drugs & of products violating trademark infringement laws. The defendant participated in the conspiracy designed to conceal from the credit card companies the fact they used their products & services to pay for precluded activities and to subvert the internal controls the credit card companies had in place to detect & prevent this type of activity. The fraud involved establishing shell corporations & web sites associated with the shell companies that falsely claimed that they sold products other than pharmaceutical drugs or products that violated trademark infringement laws. The conspirators then applied for merchant accounts from the credit card companies in the names of the shell corporations & the fake web sites. Once the merchant accounts were established, they were used to process payments for pharmaceutical drugs or products that violated trademark infringement laws….

May 29, 2018: Accokeek Man Pleads Guilty to Drug Misbranding

 

  Food & Drug Administration Office of Criminal Investigations  

Greenbelt, Maryland — Jonathan Gonzales, age 50, of Accokeek, Maryland, pleaded guilty today to introducing misbranded drugs into interstate commerce with the intent to defraud or mislead. The charges stem from a scheme to sell mislabeled drugs via the Internet.
The guilty plea was announced by United States Attorney for the District of Maryland Robert K. Hur & Special Agent in Charge Mark S. McCormack of the Food and Drug Administration, Office of Criminal Investigations – Metro Washington Field Office.
 
According to his plea agreement, beginning in 2009, Gonzales began selling products marketed as dietary supplements through eBay & his personal website, helptomakelifebetter.com.  Gonzales received these products from sources in China.
 
In 2013, the Food and Drug Administration (FDA) began to investigate Gonzales for multiple products and found that some of the products contained active pharmaceutical ingredients, in particular sibutramine and/or phenolphthalein. Sibutramine is a Schedule IV controlled substance and the active ingredient in Meridia, a prescription drug produced by Abbott and approved by the FDA in 1997 to treat obesity.  Abbott voluntarily stopped marketing Meridia at the request of the FDA after clinical data indicated an increased risk of cardiovascular adverse events, including heart attacks & strokes.  Phenolphthalein was an ingredient in some over-the-counter laxatives until 1999, when the FDA reclassified the drug as not generally recognized as safe & effective.
 
Upon discovery of the two drugs, the FDA sent Gonzales an e-mail with the results of their analyses of Gonzales’s products & noting…

May 21, 2018: Oncologist & Office Manager Sentenced in Connection with Administering Unapproved, Foreign Drugs

 

  Food and Drug Administration Office of Criminal Investigations  

ALBANY, NEW YORK – Vincent Koh, M.D., age 73, & his wife & office manager Milly Koh, age 64, of Poughkeepsie, New York, were sentenced today to pay fines of $7,500 & $3,000, respectively, for receiving in interstate commerce & delivering misbranded drugs, a misdemeanor.
 The announcement was made by United States Attorney Grant C. Jaquith; Jeffrey Ebersole, Special Agent in Charge of the Northeast Area Office of the Food & Drug Administration (FDA), Office of Criminal Investigations; and Scott J. Lampert, Special Agent in Charge of the Office of Inspector General for the U.S. Department of Health & Human Services (HHS-OIG), New York Region.
 
The Kohs each pled guilty on November 20, 2017. According to their plea agreements, Vincent Koh is a New York State-licensed medical doctor specializing in the treatment of cancer patients, with offices in Poughkeepsie and Glen Falls, New York. Milly Koh managed the practice, & is responsible for ordering the drugs that Vincent Koh prescribes. From July 2010 through March 2012, the Kohs ordered various discount oncology drugs from foreign sources that Vincent Koh prescribed & administered to patients. These drugs had not been approved by the FDA for distribution or use in the United States, & their labeling did not contain information required by law. As such, these prescription drugs were “misbranded” and illegal to receive & provide to patients in the United States. 
 
Vincent Koh & Milly Koh admitted that they regularly ordered & delivered to patients a prescription drug labeled “Mabthera.” Generally, “Mabthera” contains rituximab,…

May 21, 2018: Mississippi Man Pleads Guilty to Fraud Scheme Involving the Reselling of Food Products That Were to Be Destroyed

 

  Food & Drug Administration Office of Criminal Investigations  

A Belmont, Mississippi man who conspired with other people to resell food products that were supposed to become animal feed or be used for agricultural purposes, pleaded guilty today in U.S. District Court in Seattle to conspiracy to transport property taken by fraud in interstate commerce, announced U.S. Attorney Annette L. Hayes. RANDY SPARKS, 60, admits he purchased various food and drink products from a middleman who had agreed to destroy the goods. SPARKS then resold the products from his own grocery outlet, Silver Dollar Sales, or sold them to other discount grocery chains. The investigation did not uncover any illnesses resulting from the sales. The Court will determine any restitution owed to the victims, up to an amount of $103,709 at the time of sentencing, currently set before U.S. District Judge Robert S. Lasnik on September 7, 2018. 
According to records filed in the case, the scheme involved as many as 180 truckloads of food & beverage products from ten different food producers. The plea agreement details how SPARKS & a co-conspirator defrauded a Massachusetts-based company that arranged for the disposal & destruction of unsaleable food products. Specifically between July 2014 & October 2016, SPARKS & a co-conspirator represented that the commodities would be shipped to a South Dakota based business for destruction. The co-schemers produced fraudulent paperwork regarding the shipping & destruction of the goods. In fact, they were shipped to SPARKS who then sold them from his own grocery outlet or to other discount grocery chains.
 
The plea agreement…

May 7, 2018: Abingdon Nurse Practitioner Pleads Guilty to Conspiring to Illegally Prescribe Buprenorphine, Clonazepam, and Gabapentin at Substance Abuse Treatment Program

 

  Food and Drug Administration Office of Criminal Investigations  

 NP Matthew Sykes Also Pleaded Guilty to Illegally Distributing Oxycodone
Abingdon, VIRGINIA – United States Attorney Thomas T. Cullen announced today that an Abingdon, Virginia, nurse practitioner pleaded guilty to charges related to the illegal distribution of opiates & other prescription drugs.  
Matthew Justin Sykes, 43, pleaded guilty in the U.S. District Court for the Western District of Virginia to one count of conspiring to (a) misbrand a drug in interstate commerce by causing prescription drugs to be dispensed without a valid prescription & (b) illegally distribute Schedule III & IV controlled substances.  In addition, he pleaded guilty to eight counts of distributing oxycodone, a Schedule II opiate, one count of distributing alprazolam, a Schedule IV benzodiazepine, & one count of using the United States Postal Service in committing, causing or facilitating a felony drug trafficking offense. 
Sykes was employed by Watauga Recovery Center from March 2012 until April 2017, a practice that holds itself out as a substance abuse treatment program.  Watauga Recovery Center has locations in Virginia, Tennessee & North Carolina.  Sykes worked primarily at Watauga Recovery Center’s Duffield, Virginia, office. Sykes was also employed by E & C Counseling, another practice holding itself out as a substance abuse treatment center, located in Abingdon, Virginia.  Sykes had a valid DEA registration number during this time which was surrendered in May 2017. 
 
Sykes pleaded guilty to conspiring with other health care providers & employees at Watauga Recovery Centers, a cash payment practice, to regularly…

May 10, 2018: South Carolina Couple Sentenced to a Total of 138 Months in Prison for Trafficking Counterfeit Goods, Including Misbranded Pet Medicine

 

  Food and Drug Administration Office of Criminal Investigations  

David Haisten, 51, & Judy Haisten, 51, both of Irmo, South Carolina, were sentenced yesterday to 78 & 60 months of incarceration, respectively, by U.S. District Judge Gerald J. Pappert, announced United States Attorney William M. McSwain. A jury found the Haistens guilty in October 2017 of conspiracy as well as six counts of violating the Federal Insecticide, Fungicide, & Rodenticide Act, five counts of distributing misbranded animal drugs, & two counts of trafficking in counterfeit goods.
For about six years, & despite repeated warnings from numerous companies & government agencies, the defendants sold counterfeit DVDs, unregistered & misbranded pesticides, & misbranded animal drugs to customers online across the United States.
The defendants’ products, including pesticides that are extremely toxic in the wrong dose, posed a serious risk to animals & humans. Further, as detailed at trial, the defendants’ packaging & instructions for use increased the likelihood that an injury would occur.
“This joint venture generated millions of dollars in illegal income,” said U.S. Attorney McSwain. “Despite multiple warnings & cease & desist letters, the defendants continued to reinvent themselves & flout the law. Ultimately, it took federal arrests to stop them. Given their disdain for the law, the defendants deserved a substantial prison term.”
“To ensure that consumers know what they are purchasing and how to safely use these products, pesticides must be registered & properly labeled,” said Susan Bodine, Assistant Administrator for the Environmental Protection Agency’s Office of Enforcement & Compliance Assurance. “Today’s sentencing…

May 10, 2018: Former New Hampshire Pharmacist Sentenced to Two Years in Prison for Drug-Related Offenses

 

  Food and Drug Administration Office of Criminal Investigations  

CONCORD – Thomas Kellermann, 65, of Bedford, was sentenced to 24 months in prison for tampering with a consumer product & obtaining a controlled substance by fraud, announced United States Attorney Scott W. Murray.
According to court documents & statements in court, Kellermann was employed as a pharmacist at a pharmacy in Bedford that dispensed prescription drugs to patients, including patients at hospice facilities.  In 2011, Kellermann began abusing narcotic pain relief drugs.  In March of 2012, Kellermann took medical leave from his position.  While on medical leave in March & April 2012, Kellermann repeatedly returned to the pharmacy after business hours and on weekends & stole narcotic pain medication for his personal use.  Kellermann removed the plastic top of vials containing hydromorphone & morphine, inserted syringes into the vials, & withdrew drugs from the vials.  He then injected saline into the vials, placed a small amount of glue on top of the vials to reattach the plastic caps, & placed the vials back into the pharmacy’s inventory of narcotic drugs, which had been purchased to fill prescriptions for hospice patients.  His conduct made it appear that the vials were unused.
 
The tampering was discovered when an employee of the pharmacy detected irregularities in certain vials of drugs.  After the tampering was discovered, vials of both hydromorphone & morphine were analyzed by an independent laboratory & found to be substantially below their labeled strength.  At the time his tampering was uncovered, 62 percent of…

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