FDA Press Releases

• Published on November 23, 2022 - 00:00 GMT

  

  Prolia (denosumab) by Amgen: Drug Safety Communication - FDA Investigating Risk of Severe Hypocalcemia in Patients on Dialysis

  [Posted 11/22/2022]  AUDIENCE: Patient, Health Professional, Pharmacy    ISSUE: The FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on November 22, 2022 - 05:00 GMT

  

  ACTUALIZACIÓN: Se retiran del mercado ciertos ventiladores, máquinas BiPAP y máquinas CPAP de Philips Respironics debido a ...

  ACTUALIZACIÓN - 22 de noviembre de 2022: La FDA actualizó este comunicado de seguridad para proporcionar información actualizada sobre los informes de dispositivos médicos (en inglés) (MDR, por sus siglas en inglés) recibidos del 1 de agosto de 2022 al 31 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on November 17, 2022 - 20:24 GMT

  

  At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative Results: FDA Safety Communication

  November 17, 2022, Update: The FDA took an additional action related to the need for repeat testing following a negative COVID-19 test result on COVID-19 antigen tests -- revising the emergency use authorizations (EUAs) of all authorized COVID-19 antigen …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on November 16, 2022 - 21:43 GMT

  

  Insulet Recalls Omnipod DSAH Insulin Management System's Personal Diabetes Manager (PDM) for Risk of Battery Swelling, Leakage, or ...

  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: Insulet Omnipod DASH Insulin Management System Personal Diabetes Manager (PDM)  …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on November 15, 2022 - 17:15 GMT

  

  Insulet Issues a Nationwide Voluntary Medical Device Correction for the Omnipod® 5 Controller

  Summary Company Announcement Date: November 14, 2022 FDA Publish Date: November 15, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Issue with the Omnipod 5 Controller charging port and cable Company Name: Insulet …

  Distribution channels:
• Published on November 7, 2022 - 05:00 GMT

  

  Exactitud y limitaciones de los pulsioxímetros: Comunicado de seguridad de la FDA

  English 15 de septiembre de 2022: Aviso de reunión del Comité Asesor  La FDA anunció una reunión virtual del Panel de Dispositivos de Anestesiología y Terapia Respiratoria del Comité Asesor de Dispositivos Médicos del CDRH (en inglés) el 1 de noviembre de …

  Distribution channels:
• Published on October 31, 2022 - 19:17 GMT

  

  Reuse Tracheostomy Tubes or Switch to Appropriate Alternatives During Shortage: FDA Safety Communication

  Date Issued: October 31, 2022 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that there is a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical. A …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on October 31, 2022 - 19:17 GMT

  

  Consider Alternatives for MRI-Guided Breast Biopsy Grid Plates Due to Shortage - Letter to Health Care Providers

  October 31, 2022 The U.S. Food and Drug Administration (FDA) is recommending health care providers discuss alternative options for Magnetic Resonance Imaging (MRI)-guided breast biopsy procedures with patients if a facility is unable to perform the biopsy …

  Distribution channels:
• Published on October 31, 2022 - 04:00 GMT

  

  Comunicado de seguridad de la FDA: reutilice las cánulas de traqueostomía o cambie a alternativas adecuadas durante su escasez

  Fecha de emisión: 31 de octubre de 2022 La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) está alertando a los pacientes, cuidadores y proveedores de atención médica acerca de una escasez de cánulas de traqueostomía, incluidas las …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on October 26, 2022 - 03:23 GMT

  

  Mylan Institutional LLC, a Viatris Company, Issues a Voluntary Recall of One Lot of Octreotide Acetate Injection, 500 mcg/mL, Due ...

  Summary Company Announcement Date: October 25, 2022 FDA Publish Date: October 25, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to glass particulates Company Name: Mylan Institutional LLC, a Viatris company Brand Name: …

  Distribution channels:
• Published on October 25, 2022 - 17:09 GMT

  

  Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Recall of Two (2) Lots of Quinapril and Hydrochlorothiazide Tablets USP ...

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels:
• Published on October 25, 2022 - 15:24 GMT

  

  Do Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of Injury: FDA Safety Communication

  Date Issued: October 25, 2022 The U.S. Food and Drug Administration (FDA) is warning consumers, caregivers and health care providers not to use the recalled Mighty Bliss electric heating pads distributed by Whele LLC (doing business as Perch) due to the …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on October 24, 2022 - 18:41 GMT

  

  Whele LLC Announces National Voluntary Recall of Mighty Bliss Electric Heating Pad Due to Product Safety Concerns

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels:
• Published on October 24, 2022 - 13:08 GMT

  

  Baxter Issues Urgent Medical Device Correction Regarding Potential Radio Frequency Interference With Other Devices Near Beds ...

  Summary Company Announcement Date: October 21, 2022 FDA Publish Date: October 24, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for radio frequency (RF) interference with other medical devices. Company Name …

  Distribution channels:
• Published on October 19, 2022 - 12:51 GMT

  

  Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain ...

  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 Names: Amara View Full Face Mask DreamWisp Nasal Mask DreamWear Full Face Mask Wisp and …

  Distribution channels:
• Published on October 13, 2022 - 15:04 GMT

  

  Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-...

  Summary Company Announcement Date: October 12, 2022 FDA Publish Date: October 13, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Vial Breakage Company Name: Exela Pharma Sciences, LLC Brand Name: Brand Name(s) Product …

  Distribution channels:
• Published on October 12, 2022 - 17:38 GMT

  

  Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid Test Devices That Are Not Authorized, Cleared, or Approved by the FDA

  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: COVID-19 Ag Rapid Test Device Product Codes: See Recall Database Entry Distribution …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on October 1, 2022 - 00:59 GMT

  

  Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due ...

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels:
• Published on October 1, 2022 - 00:59 GMT

  

  LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure

  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: LifeSPARC System  Product Model: LifeSPARC Controller, Model LS-1000 Distribution …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 28, 2022 - 23:32 GMT

  

  Proper Trade LLC/My Stellar Lifestyle Issues Voluntary Nationwide Recall of Wonder Pill Capsules Due to the Presence of Undeclared ...

  COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

  Distribution channels: