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Category: Safety and Recalls

Recalls and Safety

Weis Markets Issues an Allergy Alert For Weis Quality Store-Made Cole Slaw Sold in 8 Stores Due to Undeclared Egg Allergen

Sunbury, PA – Weis Markets today issued a recall for its store-made Weis Quality Cole Slaw (one pound container) for failing to list egg as an allergen on its label. This item was made in the seafood Department.
Food allergies are an immune system reaction that occurs soon after eating a food containing an allergen. Even a tiny amount of the allergy-causing food can trigger signs and symptoms such as digestive problems, hives or swollen airways. In some people, a food allergy can cause severe symptoms or even a life-threatening reaction known as anaphylaxis.
This product was sold in eight Weis Markets’ stores in the Binghamton NY area. This recall is being issued as a precaution. The sell by dates being recalled are March 21, 18 through March 24, 18. The issue was discovered during a routine New York state inspection. Customers may return the product for a full refund.
There have been no reports of allergic reactions related to the consumption of this product to date. Other than the listed stores, no other Weis Markets’ store is included in this recall. Customers seeking additional information can call 1-(866) 999-9347, option 5. Mon-Fri, 8am to 5pm EST.
About Weis MarketsFounded in 1912, Weis Markets, Inc. is a Mid Atlantic food retailer operating 205 stores in Pennsylvania, Maryland, New Jersey, Delaware, New York, Virginia and West Virginia. For more information, please visit: WeisMarkets.com or Facebook.com/WeisMarkets.
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March 14, 2018: Meridian Nurse Practitioner Pleads Guilty to Obtaining Controlled Substances by Fraud

 

  Food & Drug Administration Office of Criminal Investigations  

BOISE – Cheri Susan Thomas, 37, of Meridian, Idaho, pleaded guilty yesterday to obtaining controlled substances by fraud, identity theft, and misbranding a drug while held for sale, U.S. Attorney Bart M. Davis announced.  A Boise federal grand jury indicted Thomas on January 9, 2018. 
According to court records, Thomas was employed as a nurse practitioner by a medical facility with multiple facilities in Idaho.  Each facility had a locked cabinet where controlled substances were kept.  Thomas did not have access to the locked cabinets. On at least seven occasions, however, Thomas accessed the cabinets at different facilities, & took bottles of Schedule II controlled substances, including hydrocodone.  Thomas then replaced the controlled substances with different medications, resealed the bottles and placed them back in the cabinets.  For example, on October 31, 2017, Thomas knowingly & intentionally removed a bottle of hydrocodone/APAP 10mg/325mg containing 20 tablets.  She removed the hydrocodone pills, replaced them with Flexeril tablets, and put the bottle back into the cabinet. The replacement of the controlled substances with other medication caused the drugs to be misbranded because the labeling became false & misleading as to the bottle’s contents.  In addition, when Thomas replaced the misbranded drug back into the cabinet, she moved the pack of bottles around to place the misbranded drugs in the back.
 
On two occasions, Thomas knowingly & intentionally forged fraudulent prescriptions to herself using another provider’s information.  For example, on October 26, 2017, Thomas forged a…

March 12, 2018: Champaign, Illinois, Resident Sentenced to One Year in Prison for Producing & Selling Over 80,000 Homemade Tramadol Capsules to Customers without Verifying Prescriptions

 

  Food & Drug Administration Office of Criminal Investigations  

OWENSBORO, Ky. – A Champaign, Illinois, resident was sentenced today in United States District Court, by Chief Judge Joseph H. McKinley, to one year in prison, ordered to pay $950.00 restitution and ordered to pay a $5,000 fine for distribution of Tramadol, a Schedule IV controlled substance, introduction of misbranded drugs, and telephone fraud, announced United States Attorney Russell M. Coleman. There is no parole in the federal system.
According to the plea agreement, Skyler Dean Prahl, 32, imported Tramadol powder from overseas & used an encapsulating machine to create Tramadol capsules.  Tramadol is a synthetic opioid drug. For several years Prahl operated an online business marketing & selling Tramadol capsules & other substances to customers throughout the United States.  Prahl sold well over 80,000 units of Tramadol to customers without inquiring or verifying that his customers had a valid prescription.
Prahl admitted that on August 31, 2015, he knowingly and intentionally possessed with the intent to distribute, & distributed Tramadol to an undercover agent.
He further admitted that on August 31, 2015, with the intent to mislead & defraud, he introduced a misbranded drug, Tramadol, into interstate commerce by shipping Tramadol from Champaign, Illinois, to Owensboro, Kentucky.  The Tramadol was misbranded because its label failed to state the name & place of business of the manufacturer, packer, and distributor, & because it failed to bear adequate directions for use.
Lastly, Prahl admitted that between January 28, 2016, & March 5, 2016, he devised a…

March 12, 2018: Pharmacist and Pharmacy Employee Sentenced for Involvement in Over $30 Million Health Care Fraud

 

  Food & Drug Administration Office of Criminal Investigations  

A pharmacist & his employee were sentenced on Friday for their involvement in a $30 million health care fraud scheme against Tricare, the health care program for military service members, Vet and their families. This case was the largest health care fraud case involving the Tricare program to go to trial. 
Benjamin G. Greenberg, United States Attorney for the Southern District of Florida, John F. Khin, Special Agent in Charge, U.S. Department of Defense Criminal Investigative Service (DCIS), Southeast Field Office, Christopher Cave, Special Agent in Charge, U.S. Postal Service, Office of Inspector General (USPS-OIG), Southern Area Field Office, Michael C. Curran, Special Agent in Charge, U.S. Army Criminal Investigation Command, Southeast Fraud Field Office, Peter H. Kuehl, Acting Special Agent in Charge, U.S. Food & Drug Administration, Office of Criminal Investigation (FDA-OCI), Miami Field Office, & Scott Rezendes, Special Agent in Charge, U.S. Office of Personnel Management, Office of Inspector General (OPM-OIG), made the announcement. 
 
On March 9, 2018, Serge Francois, 52, of Southwest Ranches, Florida was sentenced to 204 months in prison to be followed by three years supervised release by U.S. District Judge Darren P. Gayles. Francois was ordered to pay $31,259,252 in restitution. Patrick Tonge, 42, of Southwest Ranches was sentenced to 188 months in prison, to be followed by three years of supervised release. Tonge was also ordered to pay $31,259,252 in restitution.
 
On September 5, 2017, after a one-month trial, a federal jury found Francois guilty of conspiracy to commit…

March 8, 2018: Four Individuals Indicted for Trafficking in Counterfeit Goods

 

  Food & Drug Administration Office of Criminal Investigations  

Defendants face a forfeiture allegation of $3,699,901.94
SAN JUAN, P.R. – On March 7, 2018, a Federal grand jury returned a 28-count indictment charging four individuals with mail & telephone fraud conspiracy, mail fraud, trafficking in counterfeit goods, introducing misbranded articles into interstate commerce, distribution of a controlled substance, international money laundering, and smuggling, announced Rosa Emilia Rodríguez-Vélez, United States Attorney for the District of Puerto Rico. The U.S. Food & Drug Administration’s (FDA) Office of Criminal Investigations (OCI), Immigration & Customs Enforcement-Homeland Security Inquiry, & US Postal Inspectors were in charge of the investigation with the collaboration of Customs and Border Protection (CBP) and the Puerto Rico Department of Treasury (Departamento de Hacienda).  
According to the indictment, defendants Carlos Enrique Velázquez-Gines, Mayra Evelise Gines-Otero, Noriam Ivette Flores-Deleon, and Vanessa Marrero-Hernández marketed & offered numerous purported “dietary supplements” for male enhancement or weight loss, which were in fact “drugs” under the Federal Food, Drug, & Cosmetic Act (FDCA) for sale to American consumers. Defendants marketed and sold the products through “online stores” on platforms such as eBay.com and Bonanzo.com, using seller name “lostchildinpr” and “deleon1988.” The products listed in the indictment include: Foreign-labeled product, XXXplosion, Power, Hard Ten Days, Zhansheng Weige, ExtenZe, ExtenZe Plus, La Pepa Negra, Lang Yi Hao, FX3000, Shark Extract, Black Storm, USA Power, Plant Vigra, Para Hombres Paradise, Jack Rabbit, Rhino 12 Titanium, Rhino 69, African Black Ant, Paradise Ultra Plus, Figa XP, U-fit, Natural Max Slimming Advanced…

March 6, 2018: Monterey Park Woman Sentenced to Two Years in Prison for Injecting Foreign Substance into Woman for Buttocks Enhancement

 

  Food and Drug Administration Office of Criminal Investigations  

LOS ANGELES – A Monterey Park woman has been sentenced to 24 months in federal prison for injecting a woman with a foreign substance for the purpose of buttock enhancement.
Ana Bertha Diaz Hernandez, 47, was sentenced Monday by United States District Judge Philip S. Gutierrez. In addition to the prison term, Diaz was ordered to pay a $95,000 fine & $30,000 in restitution to the victim.
Diaz pleaded guilty last July to receiving & delivering an adulterated & misbranded medical device. According to a plea agreement filed in the case, the victim – who is identified as “I.T.” – filed a complaint with the California Medical Board after seeking treatments from Diaz to enhance her buttocks. I'm will.T. stated that the product Diaz injected into her buttocks migrated to her “back, hips & legs.”
During a series of treatments that cost thousands of dollars, Diaz explained to I.T. that she was injecting a “natural product,” at points claiming the injections were “lamb’s fat.” However, after a series of treatments, I will am.T. began to suffer pain & experience serious medical complications, which led her to seek the assistance of a doctor in Colombia who specializes in reversing cosmetic procedures.
During Monday’s sentencing hearing, I’m.T. explained that she has experienced a great deal of pain, suffered from infections & complications, and was hospitalized for more than three weeks due to the injections administered by Diaz. I’m.T. underwent a major surgery to remove the substance injected into her…

March 2, 2018: Woman Sentenced for Injecting Adulterated Liquid Silicone

 

  Food and Drug Administration Office of Criminal Investigations  

SAN JUAN, P.R. – Senior US District Court Judge Daniel Domínguez sentenced Rosa Betancourt-Farfán to 15 months in prison and one year of supervised release for injecting liquid silicone, an adulterated & misbranded device used for body-contouring, announced US Attorney for the District of Puerto Rico, Rosa Emilia Rodríguez-Vélez. Betancourt-Farfán was arrested & indicted in December 2016 and pled guilty on May 12, 2017. The US Food and Drug Administration’s (FDA’s) Office of Criminal Investigations (OCI) was in charge of the inquiry.
According to the information gathered during the inquiry, liquid silicone is sometimes injected into the body to “augment” tissues, such as the buttocks or breasts. When intended for tissue augmentation, liquid silicone is a “device” under the Federal Food, Drug, & Cosmetic Act, and is subject to FDA approval before it can legally be distributed and used for such use in the United States. FDA has not approved any liquid silicone products for injection to augment tissues anywhere in the body.  In addition, the injection of liquid silicone into the body for tissue augmentation can result in serious adverse health consequences, including hardening of tissue at the injection site, embolization, & even death.
On or about May 23, 2016, Puerto Rico Board of Health, Legal Division, contacted the FDA-OCI to advise of a complainant who received medical procedures from a female individual who claimed to be a nurse. It was further indicated that the complainant received treatment to enlarge his/her buttocks…

February 23, 2018: Lake Charles Veterinarian, Pharmacy Sentenced for In-Race Horse Doping Conspiracy

 

  Food & Drug Administration Office of Criminal Investigations  

LAKE CHARLES, La. – United States Attorney Alexander C. Van Hook announced today that a Lake Charles veterinarian & a Nebraska pharmacy were sentenced for selling an unapproved opioid drug 40 times more powerful than morphine for the purpose of improving the performance of race horses.
Kyle James Hebert, 43, of Lake Charles, La., was sentenced to 15 months in prison for one count of conspiracy; two counts of receipt of adulterated or misbranded drug with the intent to defraud and mislead; and one count of misbranding a drug while held for sale with the intent to defraud and mislead. Hebert was also sentenced to three years of supervised release & ordered to pay a $10,000 fine. Kohll’s Pharmacy & Healthcare Inc. of Omaha, Neb., was sentenced to five years of corporate probation and ordered to pay a $200,000 fine for one count of conspiracy & two counts of introduction of adulterated or misbranded drug in interstate commerce with intent to defraud & mislead. United States District Judge Donald E. Walter presided over the sentencing hearing.
 
Evidence admitted at the nine-day trial that ended November 7, 2017 showed that from November 11, 2010 to December 2012 Hebert, Kohll’s Pharmacy & Healthcare Inc. of Omaha, Neb., which operated as Essential Pharmacy Compounding, & other people conspired to distribute a synthetic form of the drug Dermorphin, which was then given to racehorses to improve their racing performance.  Essential Pharmacy Compounding repackaged a synthetic form of the drug that…

February 28, 2018: Two Doctors Arrested Pursuant to Federal Indictment That Alleges Bogus Sleep Studies Helped 1-800-Get-Thin Fraudulently Bill Insurance Programs Over $250 Million Related to Lap-Band Surgeries

 

  Food & Drug Administration Office of Criminal Investigations  

LOS ANGELES – Two doctors were arrested this morning on federal fraud charges stemming from more than $250 million in reportedly fraudulent bills related to the 1-800-GET-THIN Lap-Band surgery business. Julian Omidi, 49, of West Hollywood, & Mirali Zarrabi, 55, of Beverly Hills, were arrested pursuant to a federal indictment that alleges a host of criminal charges stemming from GET THIN’s Lap-Band (or bariatric) surgery & sleep study programs between May 2010 and March 2016.
Two corporations controlled, in part, by Omidi – Surgery Center Management, LLC (SCM), & Independent Medical Services, Inc. (IMS) – are also named in the 37-count superseding indictment that was unsealed today.
The indictment contains charges of mail fraud, cellphone fraud, false statements, money laundering & aggravated identity theft.
Omidi, a physician whose license was revoked in 2009, controlled, in part, the GET THIN network of entities, including SCM & IMS, that focused on the promotion & performance of elective, Lap-Band weight-loss surgeries. Omidi established procedures requiring prospective Lap-Band patients – even those covered by insurance plans he knew would never cover Lap-Band surgery – to have at least one sleep study, & employees were incentivized with commissions to make sure the studies occurred, according to the indictment. The purpose of the sleep studies was to find a second reason – a “co-morbidity,” such as sleep apnea – that GET THIN would use to convince the patient’s insurance company to pre-approve the Lap-Band procedure.
After patients underwent sleep studies – often…

February 27, 2018: Former President of Houston-Based Drug Company Convicted in $50 Million Drug Diversion Scheme

 

  Food & Drug Administration Office of Criminal Investigations  

Jerrod Nichols Smith, 48, of Houston, Texas, the former president of Houston-based pharmaceutical company, Cumberland Distribution, Inc. (“Cumberland”), was convicted yesterday by a federal jury in Nashville of conspiracy, 15 counts of mail fraud & one count of making false statements to the U.S. Food and Drug Administration (FDA), announced Donald Q. Cochran, U.S. Attorney for the Middle District of Tennessee.
The charges stemmed from an indictment in January 2013, alleging a 32-month, $50-million-dollar drug diversion scheme.  The convictions came after a five-day trial before visiting United States District Judge Billy Wilson.  Smith’s co-defendants, Charles Jeffrey Edwards, 56, & Brenda Elise Edwards, 47, both of Houston, previously pleaded guilty to related charges & will be sentenced at a later date.   
 
The evidence at trial established that, from December 2006 through August 2009, Smith & Jeff Edwards purchased millions of dollars of prescription drugs from unlicensed suppliers who had previously purchased the drugs from patients in and around New York & Miami.  In most instances, Smith had these drugs shipped to Cumberland’s Nashville warehouse where they were cleaned, sorted, re-packaged, & shipped to independent pharmacies around the country.  Generally, the diverted drugs included drugs used to combat HIV/AIDS; antipsychotic medications; anti-depressants; blood pressure medications; diabetes medications & other people.
 
Smith and Jeff Edwards also had drugs shipped from their unlicensed suppliers to shell companies in Louisiana & Arkansas.  Although these companies were licensed to sell drugs, Smith and Jeff Edwards used them as pass-through companies to…

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