Department of JusticeNorthern District of Texas FOR IMMEDIATE RELEASEThursday, September 15, 2022 A Dallas anesthesiologist who allegedly injected nerve blocking agents and other drugs into patient IV bags at a local surgery center – resulting in at least one death and multiple cardiac emergencies – was arrested Wednesday on federal criminal charges, Principal Deputy Assistant Attorney…
Five Physicians Plead Guilty to Federal Drug Crimes in Connection with HOPE Clinic
Department of JusticeSouthern District of West Virginia FOR IMMEDIATE RELEASEMonday, September 12, 2022 CHARLESTON, W.Va. – Five physicians pleaded guilty in connection with prescription practices at HOPE Clinic, a purported pain management clinic that operated in Beckley, Beaver and Charleston, West Virginia, and Wytheville, Virginia. Four of the physicians each pleaded guilty to a felony count…
Muktanand Foods Inc. Issues an Allergy Alert on Ankur Brand Golden Raisin 14 Oz (400 GM)
Summary Company Announcement Date: September 08, 2022 FDA Publish Date: September 09, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Sulfites Company Name: Muktanand Foods Inc. Brand Name: Brand Name(s) Product Description: Product Description Golden Raisin Company Announcement “ANKUR” Muktanand Foods Inc. 483 Thomas Dr. Bensenville, IL 60106 is recalling…
Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: Letter to Health Care Providers
September 6, 2022 The U.S. Food and Drug Administration (FDA) is alerting health care providers that Philips Respironics (Philips) has recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern. The recalled masks have…
Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication
Date Issued: September 8, 2022 The U.S. Food and Drug Administration (FDA) is informing the public about reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas, in the scar tissue (capsule) that forms around breast implants. The various lymphomas reported are not the same as the lymphomas described in previous FDA Communications as…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2-low breast cancer, and Nubeqa (darolutamide) in combination with docetaxel for metastatic hormone-sensitive prostate cancer
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on two recent FDA cancer drug approvals. On August 5, 2022, the FDA approved fam-trastuzumab deruxtecan-nxki (brand…
Horse Doping Seller Sentenced to 42 Months in Manhattan Federal Court
Department of JusticeSouthern District of New York FOR IMMEDIATE RELEASEThursday, September 8, 2022 Lisa Giannelli Sentenced to 42 Months in Prison Damian Williams, the United States Attorney for the Southern District of New York, announced that defendant LISA GIANNELLI, received a sentence of 42 months in prison today for her role in an approximately 20-year scheme…
Abbott MitraClip Device: Potential for Clip Lock Malfunctions – Letter to Health Care Providers
September 8, 2022 The U.S. Food and Drug Administration (FDA) is alerting health care providers about potential clip lock malfunctions with MitraClip Clip Delivery Systems manufactured by Abbott. On September 8, 2022, Abbott issued an Urgent Medical Device Correction to inform health care providers about the issue. An increased rate of reports of clip lock…
FDA D.I.S.C.O. Burst Edition: Tabrecta (capmatinib) for metastatic non-small cell lung cancer and Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-mutant non-small cell lung cancer
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide another quick update on two recent FDA cancer drug approvals. On August 10, 2022, the FDA granted regular approval to…
Philips Respironics Alerts Customers Worldwide of Updated Instructions and Labeling of Specific Sleep Therapy Masks That Contain Magnetic Headgear Clips Due to Potential Risk of Serious Injury
Summary Company Announcement Date: September 06, 2022 FDA Publish Date: September 06, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description potential risk of serious injury Company Name: Royal Philips’ subsidiary Philips Respironics Brand Name: Brand Name(s) Product Description: Product Description Certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or…