| 06/30/2020 | 06/03/2020 | Auro Pharmacies, Inc., dba Central Drugs Compounding Pharmacy | Division of Pharmaceutical Quality Operations IV | CGMP/Drug Products/Adulterated |
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Tuesday, June 30, 2020
| 06/30/2020 | 06/03/2020 | Global Commodities Corp. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
| 06/30/2020 | 06/09/2020 | Malanda, Inc. dba Mandell's Clinical Pharmacy | Division of Pharmaceutical Quality Operations I | Compounding Pharmacy/Adulterated Drug Products |
| 06/30/2020 | 06/18/2020 | Only Natural, Inc. dba Bio Nutrition, Inc. | Division of Human and Animal Food Operations East I | Unapproved New Drugs/Misbranded |
| 06/30/2020 | 06/19/2020 | Vapor Kings | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| 06/30/2020 | 06/22/2020 | Homeocare Laboratories, Inc. | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
| 06/30/2020 | 06/25/2020 | E-Cig Vault | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| 06/29/2020 | 06/26/2020 | SuperHealthGuard and Loyal Great International Ltd. | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 06/29/2020 | 06/26/2020 | Nuance Health, LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Arkansas inmates to judge: Reopen our suit
Arkansas inmates to judge: Reopen our suit: Several Arkansas death-row inmates asked a federal judge Friday to reopen their lawsuit challenging the use of midazolam as the first of three drugs used in lethal injections, arguing that a better drug may now be available.
19 hours ago - ... Equine Solutions After Finding Dirty Compounding Rooms, Potency Issues ... the letter notes that a batch of toltrazuril/pyrimethamine paste compounded for .
Saturday, June 27, 2020
Friday, June 26, 2020
Who's been charged in prescription fraud case? MOLLY BILINSKI & CLAIRE LOWE Staff Writers Jun 24, 2020
"An ongoing federal investigation into prescription drug fraud has led to 30 people so far from Atlantic County and nearby being charged since August 2017." Read more
Accused admits to role in Tricare fraud
Accused admits to role in Tricare fraud: LITTLE ROCK -- Albert Glenn Hudson of Little Rock admitted Wednesday in federal court in 2015, he participated with an Alexander doctor and a former Baxter County basketball coach to defraud Tricare, the federal government's health insurance program, of more than $12 million.
Doctor and Nurse Sentenced for Conspiracy to Commit Health Care Fraud in Compounding Pharmacy Scheme
Department of Justice
U.S. Attorney’s Office
Southern District of Mississippi
FOR IMMEDIATE RELEASE
Wednesday, June 24, 2020
Doctor and Nurse Sentenced for Conspiracy to Commit Health Care Fraud in Compounding Pharmacy Scheme
Jackson, Miss. – Dr. Thomas Edward Sturdavant, M.D., 56, of Cordova Tennessee, was sentenced Monday and Freda Cal Covington, RN, 55, of Hattiesburg, was sentenced today by Senior U.S. District Judge Keith Starrett for their roles in a conspiracy to commit health care fraud, announced U.S. Attorney Mike Hurst, Special Agent in Charge Michelle Sutphin of the Federal Bureau of Investigation (“FBI”) in Mississippi, and Special Agent in Charge Cyndy Bruce of the U.S. Department of Defense’s Criminal Investigative Service’s (“DCIS”) Southeast Field Office.
Sturdavant was sentenced to 24 months in federal prison, followed by three years of supervised release, and ordered to pay a monetary judgment of $160,000, along with restitution in the amount of $1,628,409. Covington was sentenced to 18 months in prison, followed by three years of supervised release. Co-defendant Dr. Shahjahan Sultan was sentenced on June 16, 2020 to 48 months in prison for his involvement in the conspiracy.
Beginning around May 2014, Sultan entered into a contract with a pharmacy located in Jackson County, Mississippi. Pursuant to the contract, Sultan agreed to prescribe individuals expensive compound medications in exchange for the pharmacy agreeing to pay Sultan 35% of the reimbursements it received for the prescriptions Sultan authorized.
In September 2014, Dr. Sultan offered to pay Dr. Sturdavant $900,000 to perform telemedicine services and prescribe more expensive compounded medications that had no medical effectiveness. Dr. Sturdavant also signed more than fifty prescriptions for the compounded medications for individuals he did not examine. As a nurse, Covington helped further the conspiracy by identifying individuals in places like Jones County, Mississippi who had insurance that covered the expensive compounded medications. She conducted cursory physical examinations of patients at places like gas stations and public playgrounds and falsified patient assessments for patients she knew did not need the expensive compounded medications.
Sturdivant pled guilty before Judge Starrett on November 21, 2019, and Covington pled guilty on October 15, 2019.
Fallon Page, another nurse, pled guilty on November 21, 2019, to mail fraud for her involvement with having the unnecessary compound medications shipped to patients by the pharmacy. She will be sentenced by Judge Starrett on July 7, 2020.
The case was investigated by the FBI and DCIS. Assistant Chief Dustin M. Davis and Trial Attorney Sara E. Porter of the Criminal Division’s Fraud Section and Assistant U.S. Attorney Kathlyn R. Van Buskirk of the Southern District of Mississippi prosecuted the case.
Topic(s):
Health Care Fraud
Tuesday, June 23, 2020
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| 06/17/2020 | 06/15/2020 | Sonrisa Family Dental dba www.mycovidtest19.com | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 06/19/2020 | 06/18/2020 | Project 1600 Inc. | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
| 06/17/2020 | 06/10/2020 | Medakit Ltd | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | ||
| 06/17/2020 | 06/15/2020 | antibodiescheck.com | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19 |
| 06/22/2020 | 06/19/2020 | North Isle Wellness Center | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 06/23/2020 | 06/17/2020 | KBMO Diagnostics, LLC | Center for Devices and Radiological Health | Adulterated and Misbranded Products Related to Coronavirus Disease 2019 |
| 06/23/2020 | 06/17/2020 | BHP Holdings Inc. dba BioPure Healing Products | Division of Human and Animal Food Operations West VI | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
| 06/23/2020 | 06/12/2020 | Nanobots Healthcare, LLC dba Assurance Infusion | Division of Pharmaceutical Quality Operations II | Compounding Pharmacy/Adulterated Drug Products |
| 06/23/2020 | 06/12/2020 | Rapid Equine Solutions, LLC | Division of Pharmaceutical Quality Operations I | Animal Drugs/Adulterated |
| 06/23/2020 | 06/08/2020 | Diamond Rock Food Imports Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
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Monday, June 22, 2020
FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem
[6/19/2020] FDA advises consumers not to use any hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, due to the potential presence of methanol (wood alcohol), a substance that can be toxic when absorbed through the skin or ingested. FDA has identified the following products manufactured by Eskbiochem:
- All-Clean Hand Sanitizer (NDC: 74589-002-01)
- Esk Biochem Hand Sanitizer (NDC: 74589-007-01)
- CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-008-04)
- Lavar 70 Gel Hand Sanitizer (NDC: 74589-006-01)
- The Good Gel Antibacterial Gel Hand Sanitizer (NDC: 74589-010-10)
- CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-005-03)
- CleanCare NoGerm Advanced Hand Sanitizer 75% Alcohol (NDC: 74589-009-01)
- CleanCare NoGerm Advanced Hand Sanitizer 80% Alcohol (NDC: 74589-003-01)
- Saniderm Advanced Hand Sanitizer (NDC: 74589-001-01)
FDA tested samples of Lavar Gel and CleanCare No Germ. Lavar Gel contains 81 percent (v/v) methanol and no ethyl alcohol, and CleanCare No Germ contains 28 percent (v/v) methanol. Methanol is not an acceptable ingredient for hand sanitizers and should not be used due to its toxic effects.
Consumers who have been exposed to hand sanitizer containing methanol should seek immediate treatment, which is critical for potential reversal of toxic effects of methanol poisoning. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although all persons using these products on their hands are at risk, young children who accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.
On June 17, 2020, FDA contacted Eskbiochem to recommend the company remove its hand sanitizer products from the market due to the risks associated with methanol poisoning. To date, the company has not taken action to remove these potentially dangerous products from the market. Therefore, FDA recommends consumers stop using these hand sanitizers and dispose of them immediately in appropriate hazardous waste containers. Do not flush or pour these products down the drain.
FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommend consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol.
FDA remains vigilant and will continue to take action when quality issues arise with hand sanitizers. Additionally, the agency is concerned with false and misleading claims for hand sanitizers, for example that they can provide prolonged protection such as 24-hours against viruses including COVID-19, since there is no evidence to support these claims.
To date, FDA is not aware of any reports of adverse events associated with these hand sanitizer products. FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program:
Friday, June 19, 2020
Mitchell “Chad” Barrett, 54, of Gulf Breeze, Florida; David “Jason” Rutland, 41, of Bolton, Mississippi; and Thomas “Tommy” Shoemaker, 56, of Rayville, Louisiana were charged May 27 but federal authorities, with the indictment unsealed on June 12, 2020
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Friday, June 12, 2020
Three Charged in $180 Million Health Care Fraud and Money Laundering Scheme
An indictment against three individuals for their alleged involvement in various schemes to defraud Medicare, TRICARE, and private insurance companies, and their conspiracy to launder the proceeds has been unsealed today. The conduct allegedly resulted in more than $180 million in fraudulent billings.
Assistant Attorney General Brian A. Benczkowski of the Justice Department’s Criminal Division, U.S. Attorney Mike Hurst of the Southern District of Mississippi, Special Agent in Charge Michelle Sutphin of the FBI’s Jackson Field Office, and Special Agent in Charge Cyndy Bruce of the Defense Criminal Investigative Service (DCIS) Southeast Field Office made the announcement.
Mitchell “Chad” Barrett, 54, of Gulf Breeze, Florida, David “Jason” Rutland, 41, of Bolton, Mississippi, and Thomas “Tommy” Shoemaker, 56, of Rayville, Louisiana were charged on May 27, 2020, in the Southern District of Mississippi.
The indictment alleges that between September 2011 and January 2016, Barrett, Rutland, and Shoemaker conspired to and engaged in a scheme to defraud numerous health care benefit programs of more than $180 million, including more than $50 million from federal healthcare programs. Using several pharmacies, including Gluckstadt Special Care Pharmacy and Compounding LLC, World Health Industries Inc., Opus Rx LLC, and Rx Pro Pharmacy and Compounding LLC, the defendants, as alleged, fraudulently formulated, dispensed, shipped, and billed insurance companies for compound medications in the form of topical creams and capsules, some of which contained controlled substances.
To further facilitate their scheme to defraud health care benefit programs, the defendants allegedly conspired to and engaged in a scheme to solicit and pay kickbacks and bribes to marketers, physicians, other medical providers, and beneficiaries to refer, prescribe, and receive prescriptions for medically unnecessary compound medications. The defendants also allegedly conspired to and engaged in a scheme to launder the proceeds of their fraudulent activity by concealing the proceeds they obtained and conducting monetary transactions of a value greater than $10,000, including the purchase of numerous assets, such as real estate, luxury automobiles, a three-carat diamond, and other high-priced goods.
The charges announced today target alleged schemes billing Medicare, TRICARE (a health insurance program for members and veterans of the armed forces and their families) and private insurance companies for medically unnecessary compounded medications.
The charges and allegations contained in the indictments are merely accusations. The defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.
This case is being investigated by the FBI, DCIS, and IRS-CI. The U.S. Postal Inspection Service and Office of Personnel Management’s Office of Inspector General also assisted with the case. Trial Attorneys Emily Cohen, Amanda Wick, and Steven Brantley of the Criminal Division’s Money Laundering and Asset Recovery Section and Assistant U.S. Attorney Kathlyn Van Buskirk of the Southern District of Mississippi are prosecuting the case with the support and assistance of Trial Attorney Dustin Davis of the Fraud Section.
The year 2020 marks the 150th anniversary of the Department of Justice. Learn more about the history of our agency at www.Justice.gov/Celebrating150Years.
Topic(s):
Health Care Fraud
Press Release Number:
20-540
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