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Category: Safety and Recalls

Recalls and Safety

Medication Safety: Advice for New Parents

 Subscribe: FDA Consumer Health Information
Mother’s Day & Father’s Day are special for parents. But they can also be stressful times for new moms and dads caring for a newborn or infant.
Your health care provider can be a great resource. A good time to check in is during preventive “well-child” health visits with your child’s pediatrician, says Donna L. Snyder, M.D., F.A.A.P., a pediatrician with the U.S. Food & Drug Administration’s Office of Pediatric Therapeutics. These visits can continue at periods throughout childhood & adolescence.
But if you’re between appointments & think your child is sick, or just have questions, contact your health care provider to confirm what to do next, Snyder says. And consider the following advice on medication safety—for prescription and over the counter medicines.
Get Expert Advice Before Giving Medication to Your Baby
Certain medications may not be appropriate for your baby, so you should ask your health care provider before giving your child any medication, says Snyder. If he or she has recommended a medicine for your infant, ask questions to be sure you use the right dose.
Store Medications Safely
Store any medications that you or your baby may take out of reach of your child, says Snyder. She notes that babies can start to crawl as early as 5 to 6 months. “But even if babies are under the age when you’d expect them to be able to get to your medication, get into the habit of putting medication out of their reach,” she advises.
Also read all storage instructions. “For instance,…

May 3, 2018: Indictment: Kansas EMT Stole Morphine from Vials


  Food & Drug Administration Office of Criminal Investigations  

WICHITA, KAN. – An EMT in Jackson County, Kan., is charged with stealing morphine from vials, U.S. Attorney Stephen McAllister said. 
Colby W. Vanwagoner, 32, Mayetta, Kan., is charged with two counts of tampering with consumer products and one count of making a false statement to federal investigators. A grand jury indictment returned April 26 & unsealed May 2 alleges the crimes took place while Vanwagoner was working for the Jackson County Emergency Medical Service in Holton, Kan.
The indictment alleges Vanwagoner tampered with vials of morphine sulfate. It is alleged he replaced morphine with saline solution & put the vials back into narcotic boxes on ambulances or in office stocks. Tests showed the concentration of morphine in vials that had been tampered with was low as 1 percent or less.
If convicted, he faces up to 10 years in federal prison and a fine up to $250,000 on the on the tampering charges & up to five years & a fine up to $250,000 on the charge of lying to investigators. The Food and Drug Administration – Office of Criminal Investigations investigated. Assistant U.S. Attorney Debra Barnett is prosecuting.
In all cases, defendants are presumed innocent until and unless proven guilty. The indictments merely contain allegations of criminal conduct.
USAO – Kansas

May 1, 2018: Nurses Sentenced to Prison for Stealing Opioids from Colorado Hospitals


  Food & Drug Administration Office of Criminal Investigations  

DENVER – The United States Attorney’s Office for the District of Colorado announces that two Colorado nurses who stole opioids from hospitals were sentenced to prison by the Honorable R. Brooke Jackson of the United States District Court for the District of Colorado.  
Lisa Marie Jones, 43, of Castle Rock, was sentenced to fourteen months imprisonment to be followed by three years of supervised release on April 19, 2018.  According to Court documents, Jones was a nurse at the Vet Affairs Medical Center in Denver, & a free-standing UCHealth emergency room in 2016, when she stole hydromorphone, morphine, & fentanyl from the facilities for personal use.  Jones primarily stole the “waste” medication left after administering the controlled substances to patients.  She tampered with two vials of fentanyl at the emergency facility, removing all of the drug, replacing it with saline, and “re-sealing” the vials with skin glue.  Jones placed the tampered vials back into the automated medication management machine for potential use on future patients.  The tampered vials were discovered before they could be used on any patients.  Jones previously pleaded guilty to one count of theft of a controlled substance by deception & one count of tampering with a consumer product.  The Court sentenced Jones to fourteen months of imprisonment and three years of supervised release on each count, to run concurrently.
Marlene Gilmore, 28, of Wellington, was sentenced to four months imprisonment to be followed by one year of supervised release on April 26, 2018. …

May 1, 2018: Vero Beach Orthopedic Surgeon Convicted at Trial of Fentanyl Analog Drug Conspiracy Resulting in Death


  Food & Drug Administration Office of Criminal Investigations  

Johnny Clyde Benjamin, Jr., M.D., an orthopedic surgeon practicing in Vero Beach, Florida, was found guilty by a federal jury in Fort Lauderdale, on April 27, 2018, of conspiracy to possess with intent to distribute Furanyl Fentanyl which resulted in death, aiding & abetting the distribution of Furanyl Fentanyl which resulted in death, attempted possession with intent to distribute Acetyl Fentanyl, possession with intent to distribute Oxycodone, & conspiracy to possess with intent to distribute Hydrocodone and Oxycodone.
Benjamin G. Greenberg, United States Attorney for the Southern District of Florida; Adolphus P. Wright, Special Agent in Charge, Drug Enforcement Administration (DEA), Miami Field Division, Peter J. Forcelli, Special Agent in Charge, Bureau of Alcohol, Tobacco, Firearms & Explosives (ATF), Miami Field Office; Peter Kuehl, Acting Special Agent in Charge, U.S. Food and Drug Administration, Office of Criminal Investigations (FDA-OCI); Mark Selby, Special Agent in Charge, U.S. Immigration and Custom Enforcement’s Homeland Security Investigations (ICE-HSI); Dave Aronberg, State Attorney, Palm Beach County State Attorney’s Office; Bruce Colton, State Attorney for the 19th Judicial Circuit; Ric Bradshaw, Sheriff, Palm Beach County Sheriff’s Office (PBSO); Deryl Loar, Sheriff, Indian River County Sheriff’s Office; and Renee Purden, Chief, Orlando Melbourne Airport Police Dept., made the announcement.
The evidence presented at the trial established that on September 1, 2016, a young woman who resided in Wellington, Florida died after overdosing on counterfeit oxycodone pills.  The pills contained a Fentanyl analog, Furanyl Fentanyl, as the active ingredient.  Furanyl Fentanyl is…

April 17, 2018: Tampa Resident Sentenced to More Than 20 Years in Federal Prison for Tricare Health Care Fraud Scheme


  Food & Drug Administration Office of Criminal Investigations  

A Tampa resident, who was previously convicted at trial, was sentenced to more than 20 years in federal prison for his involvement in a Tricare health care fraud scheme, receiving kickbacks & money laundering. 
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 Inquiry Command’s (CID) Major Procurement Fraud Unit, made the announcement. 
Monty Ray Grow, 46, of Tampa, was sentenced by United States District Judge Federico A. Moreno to 262 months in prison & ordered to pay approximately $18 million in restitution. On February 5, 2018, a federal jury in Miami convicted Grow, of 18 criminal charges, including: conspiracy to commit health care fraud, in violation of Title 18, United States Code, Section 1347; conspiracy to pay & receive health care kickbacks, in violation of Title 18, United States Code,  371; unlawful receipt of health care kickbacks, in violation of Title 42, United States Code, Section 1320a-7(b)(1)(A); and money laundering, in violation of Title 18, United States Code, Section 1957. 
Evidence presented at trial established that during an eight-month period 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…

April 27, 2018: Seller of Counterfeit & Unapproved Pharmaceuticals Sentenced to Prison


  Food & Drug Administration Office of Criminal Investigations  

SAN DIEGO – Tijuana resident Alejandro Hernandez was sentenced in federal court today to 30 months in custody for conspiring to smuggle & sell counterfeit & unapproved drugs. The defendant was also ordered to pay restitution of $9,750 to Eli Lilly & Co., for losses related to his sale of counterfeit products. 
During a long-term undercover inquiry, agents purchased counterfeit or unapproved pharmaceuticals from Hernandez on six separate occasions – oftentimes in a Chula Vista parking lot, paying for them with cash.  The drugs were all labeled in the Spanish language, & included products such as Buscapina, Prodolina & Neo-Melubrina, which are not approved by the Food & Drug Administration for use in the United States. Hernandez also provided counterfeit versions of several drugs, including Viagra & Cialis. 
Hernandez told undercover operatives that his boss in Mexico had other employees, including a driver who would walk or drive across the border with the pharmaceuticals.  Surveillance indicated that Hernandez stored the illegal pharmaceuticals at various self-storage units near the border.  Agents arrested Hernandez earlier this year as he made a delivery of pharmaceuticals, and executed a search warrant at one of his self-storage units. The search yielded over $250,000 of unapproved and counterfeit pharmaceuticals in the storage unit, as well as ledgers documenting years of sales. 
“This office is committed to protecting the health & safety of the citizens in our district by keeping counterfeit & unapproved prescription drugs off the market, and prosecuting individuals…

April 13, 2018: Canadian Drug Firm Admits Selling Counterfeit & Misbranded Prescription Drugs Throughout the United States


  Food & Drug Administration Office of Criminal Investigations  

Missoula — Kristjan Thorkelson, a resident of Manitoba, Canada, together with several Canadian companies associated with Thorkelson, including Canada Drugs, Rockley Ventures, & River East Supplies, admitted today to widespread illegal sales of misbranded & counterfeit prescription drugs in the United States. Chief U.S. District Court Judge Dana Christensen sentenced the Canadian companies to forfeit $29,000,000 of the proceeds of their illegal scheme, to pay a fine of $5,000,000, and to five years of probation. The court sentenced Thorkelson individually to pay a fine of $250,000 & to five years of probation with the first six months in home confinement. Thorkelson & the associated companies were also ordered to permanently cease their illegal operations, surrender to the United States all domain names & websites from their businesses, and cooperate with the United States Justice Department & the Food and Drug Administration (FDA) in any further criminal investigations. 
In 2010, it came to the attention of the FDA that Canada Drugs was shipping to health care providers in the United States prescription drugs that were unapproved in the United States, labelled with foreign languages, & that lacked adequate instructions for use.  During this time, Thorkelson was CEO of Canada Drugs. Further inquiry revealed that various entities affiliated with Canada Drugs were smuggling unapproved & misbranded drugs intended for sale in foreign countries into the United States, including for sale to providers in Montana. To facilitate its sales, Canada Drugs purchased other companies engaged in this…

April 12, 2018: Chinese Citizen Pleads Guilty to Mail Fraud Related to Dietary Supplement Scheme


  Food & Drug Administration Office of Criminal Investigations  

Zhang Xiao Dong (a.k.a. Mark Zhang), of Shanghai, China, pleaded guilty in Dallas to committing mail fraud in connection with a scheme to sell mislabeled dietary supplements, the Department of Justice announced today.  
Zhang was the sales manager for Genabolix USA Inc. & Shanghai Yongyi Biotechnology Co. Ltd., Chinese firms that sell raw ingredients for use in dietary supplements. In pleading guilty, Zhang admitted that he agreed to help sell synthetic stimulant ingredients, including the substance known as 1,4-DMAA, to a purported dietary supplement manufacturer in the United States. According to an indictment returned in October 2017, Zhang and two co-defendants agreed with a confidential government informant to either mislabel the synthetic ingredients or otherwise help to hide the true nature of a proposed dietary supplement from retailers. Zhang admitted that he knew major American dietary supplement retailers would refuse to carry supplements known to contain certain stimulants, such as DMAA.  
“Americans should be able to trust the products they consume are safe,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “We will continue to investigate and prosecute those who enable the sale of mislabeled & potentially unsafe dietary supplements.”
Zhang pleaded guilty before U.S. Magistrate Judge David Horan of the Northern District of Texas. He faces a statutory maximum sentence of 20 years of imprisonment. The Court set sentencing for Oct. 15.
“U.S. consumers trust that their dietary supplements are safe and contain appropriate labeling. When unscrupulous…

April 6, 2018: New Hampshire Residents Sentenced for Participating in Scheme to Distribute Misbranded Drugs


  Food & Drug Administration Office of Criminal Investigations  

CONCORD – United States Attorney Scott W. Murray announced that John Hayes, 53, & his wife, Plabpleung Hayes, 50, of New Ipswich were sentenced today for participating in a scheme to distribute misbranded prescription drugs that they obtained from India.  
John Hayes was sentenced to serve 30 months in prison & to pay a $2,500 fine.  Plabpleung Hayes was sentenced to serve a year & a day in prison.  Both previously pleaded guilty to participating in a conspiracy to distribute misbranded prescription drugs into interstate commerce.  Plabpleung Hayes faces possible deportation to Thailand following the completion of her sentence.
According to court documents & statements in court, the defendants conspired with others, including John Hayes’ brother (James Hayes) & sister-in-law (Shannon Hayes) in North Carolina, to receive shipments of pills from India.  During the course of the conspiracy, John and Plabpleung Hayes, along with their co-conspirators in North Carolina, received over 2.4 million prescription drugs from India, many of which were controlled substances.  The defendants attempted to conceal their scheme by having the drugs shipped to numerous Post Office boxes, including boxes in southern New Hampshire & northern Massachusetts.
In addition, United States Customs and Border Protection (CBP) seized more than 60 shipments from India destined for locations controlled by John Hayes that were found to contain more than 100,000 additional pills.  The pills were packaged in blister packs, with no packaging that a person would recognize as retail-type packaging, and with no directions…

April 4, 2018: Fences Indicted in Multi-Million Dollar, Multi-State Criminal Theft Operations


  Food & Drug Administration Office of Criminal Investigations  

HOUSTON – Two brothers are set to appear in court following the return of two indictments for their separate operations involving the possession & interstate transportation of stolen property, announced U.S. Attorney Ryan K. Patrick.
A federal grand jury returned the indictments March 28, 2018, against Yasser Saleh Ouwad, 47, of & Bilal Saleh Awad, 45, both of Houston. Luis Garcia-Oyuela, 33, a Honduran national who illegally resided in Houston is also charged for his role in Ouwad’s organization. Ouwad and Garcia-Oyuela are set for their arraignment today before U.S. Magistrate Judge Frances Stacy at 10:00 a.m. Awad is scheduled for a detention hearing at 2:00 p.m. today before Judge Stacy. The indictment remains sealed as to other people charged but not as yet in custody for their roles in the organizations.
Ouwad and Awad are alleged to have acted as high-level “fences” in multi-million dollar, multi-state criminal enterprises involving stolen over-the-counter (OTC) medicine, diabetic test strips & health and beauty supplies. The enterprises reportedly used “boosters” to steal OTC medication from large retailers.
A “booster” allegedly steals goods & merchandise not for personal use but for re-sale to a “fence” for a fraction of its retail value. A “fence” is a person who receives stolen goods & merchandise from “boosters” & other people. The “fence” then re-sells the stolen goods & merchandise to third parties for a profit.
The scope of these criminal enterprises ranged from June 2015 to March 2018, according to the charges. 

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