FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on January 2, 2023 - 14:44 GMT

IBSA Pharma Inc. Issues Voluntary Nationwide Recall of Select Lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to ...

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: Healthcare & Pharmaceuticals Industry

Published on December 27, 2022 - 05:00 GMT

Accord Healthcare Inc. Issues Nationwide Voluntary Recall of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 ...

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 …

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Published on December 27, 2022 - 05:00 GMT

Hospira, Inc. Issues A Voluntary Nationwide Recall For One Lot of Vancomycin Hydrochloride Injection, USP 1.5g/vial, Due To The ...

Summary Company Announcement Date: December 22, 2022 FDA Publish Date: December 27, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Visible Glass Particulates Company Name: Hospira, Inc. Brand Name: Brand Name(s) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 27, 2022 - 05:00 GMT

GFA Production (Xiamen) Co., Ltd. Issues Voluntary Nationwide Recall of Easy Care First Aid® Burn Cream and First Aid Kits Due to ...

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: Healthcare & Pharmaceuticals Industry

Published on December 22, 2022 - 20:15 GMT

Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and ...

Date Issued: December 22, 2022 The U.S. Food and Drug Administration (FDA) is providing additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 21, 2022 - 20:56 GMT

Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Four Lots of Quinapril Tablets Due to Potential Presence of N-...

Summary Company Announcement Date: December 21, 2022 FDA Publish Date: December 21, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of nitrosamine impurity, N-Nitroso-Quinapril Company Name: Lupin Pharmaceuticals Inc. …

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Published on December 20, 2022 - 21:01 GMT

Whele LLC Recalls Mighty Bliss Electric Heating Pads Due to Injury Risks Including Electric Shocks, Skin Burns, and Rashes

The recall described in this notice is for the same issue that was announced in Do Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of Injury: FDA Safety Communication | FDA on October 25, 2022. The FDA has identified this as a Class I recall …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 20, 2022 - 16:32 GMT

Arrow International, LLC, subsidiary of Teleflex, Inc Recalls Arrow AutoCAT 2, AC3 Intra-Aortic Balloon Pumps for Unexpectedly ...

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: Arrow AutoCAT 2, AutoCAT 2 Refurbished, AeroautoCAT 2, AutoCAT 2 Wave, AutoCAT 2 …

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Published on December 16, 2022 - 20:15 GMT

Teleflex and Arrow International, LLC Recall Arrow MAC Two-Lumen Central Venous Access and Pressure Injectable Arrowg+ard Blue ...

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: Arrow MAC Two-Lumen Central Venous Access Kits; Arrow Pressure Injectable Arrowg+ard …

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Published on December 12, 2022 - 20:20 GMT

Voluntary Recall of Three Detect Covid-19 Test Lots

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 Summary Company …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 12, 2022 - 17:36 GMT

2020 Letters to Health Care Providers

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Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 6, 2022 - 05:00 GMT

Actualización de los sistemas endovasculares de injerto de AAA Endologix AFX y el riesgo de endofuga de tipo III: Comunicado de ...

English Fecha de emisión: 6 de diciembre de 2022 La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) está actualizando nuestro comunicado de seguridad de enero de 2022 (en inglés) sobre el uso de los injertos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 29, 2022 - 20:48 GMT

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

Summary Company Announcement Date: November 28, 2022 FDA Publish Date: November 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Vial Breakage Company Name: Exela Pharma Sciences, LLC Brand Name: Product Description: Product …

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Published on November 23, 2022 - 17:42 GMT

Baxter Hillrom Recalls WatchCare Incontinence Management System (IMS) for Risk of RF Interference with Nearby Medical Equipment

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: WatchCare Incontinence Management System (IMS) Product Models: P7900B Centrella …

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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 …

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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 …

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