English Fecha de publicación: 8 de marzo de 2023 La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) está proporcionando una actualización sobre los reportes de carcinoma de células escamosas (SCC, por sus siglas en inglés) en el tejido cicatricial (cápsula) que se forma alrededor de los implantes…
Philips Respironics Recalls Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or Insufficient Therapy
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Philips Respironics DreamStation1 (Uno Remediated Devices) Product Models: REP DreamStation Auto CPAP Recert, DreamStation Auto, FR REP DreamStation Auto BiPAP, DOM-RECRT, and REP DreamStation Auto…
Fresh Express Incorporated Announces Precautionary Recall of Expired Fresh Salad Kits Due to Potential Health Risk
Summary Company Announcement Date: April 07, 2023 FDA Publish Date: April 07, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Listeria monocytogenes Company Name: Fresh Express Incorporated Brand Name: Brand Name(s) Fresh Express & Publix Product Description: Product Description Salad Kits Company Announcement Fresh Express Incorporated is voluntarily recalling a limited…
Revolution Farms, LLC Announces Expanded Recall of Lettuce Due to Possible Health Risk
Summary Company Announcement Date: April 06, 2023 FDA Publish Date: April 07, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Listeria monocytogenes Company Name: Revolution Farms Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description Lettuce & Salad Kits Company Announcement Revolution Farms, LLC of Caledonia, Michigan is expanding…
Abbott Recalls the Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems for Risk of Extreme Heat and Fire
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: FreeStyle Libre Flash Glucose Monitoring System, FreeStyle Libre 14 day Flash Glucose Monitoring System, FreeStyle Libre 2 Flash Glucose Monitoring System Product Models: all Reader…
Revolution Farms Announces the Voluntary Recall of Lettuce Because of Possible Health Risk
Summary Company Announcement Date: April 05, 2023 FDA Publish Date: April 05, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Listeria monocytogenes Company Name: Revolution Farms Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description Lettuce & Salad Kits Company Announcement Revolution Farms of Caledonia, Michigan is voluntarily recalling…
FDA D.I.S.C.O. Burst Edition: FDA approval of Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients with low-grade glioma with a BRAF V600E mutation
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 a recent FDA cancer drug approval. On March 16, 2023, the FDA approved dabrafenib (brand name…
UPDATED: Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer & Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Due to Presence of Methanol
Summary Company Announcement Date: March 27, 2023 FDA Publish Date: March 28, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Presence of Methanol Company Name: Jarman’s Midwest Cleaning Systems, Inc. Brand Name: Brand Name(s) Midwest Cleaning Solutions, Clean Pro Supply, SOFT HANDS Product Description: Product Description Alcohol Antiseptic 80% Topical Solution…
Nurse Practitioner Sentenced in Twelve Million Dollar Health Care Fraud Scheme
Department of JusticeU.S. Attorney’s OfficeDistrict of Rhode Island FOR IMMEDIATE RELEASEWednesday, April 5, 2023 PROVIDENCE, R.I. – A registered nurse and nurse practitioner, who defrauded commercial health insurers and Medicare of nearly $12 million by devising and executing fraudulent billing schemes in three states seeking payment for patient services that were never performed, has been…
New Braunfels Men Plead Guilty to Selling Misbranded Drugs
Department of JusticeU.S. Attorney’s OfficeWestern District of Texas FOR IMMEDIATE RELEASEWednesday, April 5, 2023 SAN ANTONIO – Two New Braunfels men pleaded guilty in a federal court in San Antonio to selling non-controlled but dangerous substances through the mail. According to court documents, Evan Asher Field, 42, and Michael Dominic Diaz, 30, purchased bulk quantities…