Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASETuesday, July 2, 2019 BOSTON – A Haverhill nurse was charged in federal court in Boston with tampering with patients’ morphine. Brianna Duffy, 32, was indicted on one count of tampering with a consumer product and one count of acquiring a controlled substance by fraud or deception….
Two Pharmacists at New England Compounding Center Convicted by Federal Jury
Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEFriday, May 3, 2019 Third verification pharmacist sentenced today BOSTON – Two former verification pharmacists at New England Compounding Center (NECC) were convicted yesterday of violating the Food, Drug, and Cosmetic Act (FDCA). The convictions mark the fourth and final trial resulting from the 2014 indictment of…
West Hollywood Doctor Taken into Custody in Health Care Fraud Case Involving Human Growth Hormone for Patients with HIV
Department of JusticeU.S. Attorney’s OfficeCentral District of California FOR IMMEDIATE RELEASEWednesday, July 3, 2019 LOS ANGELES – A doctor who operates a medical clinic in West Hollywood where he specializes in treating HIV patients has been taken into custody pursuant to federal charges that allege he engaged in a long-running scheme to defraud health insurance companies in…
URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication
Date Issued: October 1, 2019 The U.S. Food and Drug Administration (FDA) is informing patients, health care providers and facility staff, and manufacturers about cybersecurity vulnerabilities that may introduce risks for certain medical devices and hospital networks. The FDA is not aware of any confirmed adverse events related to these vulnerabilities. However, software to exploit…
FDA’s Forensic Chemistry Center Playing Critical Role in Vaping Illness Investigation
Image CaptionForensic Chemistry Center scientists using devices in the analysis of vaping fluid samples. The U.S. Food and Drug Administration’s mission to protect the public health often depends on the agency’s laboratories being able to quickly and accurately analyze samples and to report those results for regulatory action. FDA’s Forensic Chemistry Center serves as the…
Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of all Sterile Compounded Drug Products Due to a Lack of Sterility Assurance
Summary Company Announcement Date: October 10, 2019 FDA Publish Date: October 10, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential lack of sterility assurance Company Name: Innoveix Pharmaceuticals, Inc. Brand Name: Brand Name(s) Innoveix Pharmaceuticals, Inc. Product Description: Product Description Injectable Human Chorionic Gonadotropin (HCG) and injectable Sermorelin w/GHRP2 Company Announcement Innoveix…
Insys Therapeutics Agrees to Enter into $225 Million Global Resolution of Criminal and Civil Investigations
Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEWednesday, June 5, 2019 Company admits to illegal promotion of Subsys, a powerful opioid painkiller BOSTON – Opioid manufacturer Insys Therapeutics agreed to a global resolution to settle the government’s separate criminal and civil investigations, the Department of Justice announced today. As part of the criminal resolution,…
Michigan Man Sentenced for Unlawfully Importing and Distributing Misbranded Drugs
U.S. Department of Justice FOR IMMEDIATE RELEASEWednesday, May 8, 2019 Matthew Dailey, 36, of Royal Oak, Michigan, was sentenced today to two years in prison for illegally importing kratom—a powerful psychoactive substance—and selling it unlawfully through unapproved claims that it could treat serious diseases and medical conditions, including opiate withdrawal symptoms, the Department of Justice announced….
Pharmaceutical Company Agrees to Pay $17.5 Million to Resolve Allegations of Kickbacks to Medicare Patients and Physicians
U.S. Department of Justice FOR IMMEDIATE RELEASETuesday, April 30, 2019 The Justice Department announced today that US WorldMeds LLC (USWM) has agreed to pay $17.5 million to resolve allegations that it violated the False Claims Act, 31 U.S.C. §§ 3729 et seq., by paying kickbacks to patients and physicians to improperly induce prescriptions of its drugs,…
Pensacola Woman Pleads Guilty to Selling Counterfeit Contact Lenses
Department of JusticeU.S. Attorney’s OfficeNorthern District of Florida FOR IMMEDIATE RELEASEThursday, June 27, 2019 PENSACOLA, FLORIDA – Son Chu Gilliam, 51, of Pensacola, Florida, pleaded guilty today to misdemeanor charges of receipt of adulterated and misbranded devices, and sale of prescription devices without a prescription — those devices being contact lenses. Lawrence Keefe, United States Attorney…