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Published on April 5, 2023 - 16:18 GMT

Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests: FDA Safety Communication

Date Issued: May 4, 2023 The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers to stop using and throw out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics. The …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 5, 2023 - 13:26 GMT

UPDATE - Akorn Issues Voluntary Nationwide Recall of Various Human and Animal Drug Products Within Expiry Due to Company Shutdown

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 April 5, 2023 - 11:00 GMT

Family Dollar is Initiating a Voluntary Recall of Certain Over-the-Counter Drug Products Because the Products Have Been Stored ...

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 March 31, 2023 - 20:02 GMT

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750mg/5mL Due to Potential ...

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 …

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Published on March 31, 2023 - 17:23 GMT

Recall by Datascope/Getinge of Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected ...

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: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 30, 2023 - 15:29 GMT

Evaluation of Safety Concerns with Certain Dental Devices Used on Adults – FDA Safety Communication

Date Issued: March 30, 2023 The U.S. Food and Drug Administration (FDA) is evaluating safety concerns with the use of certain dental devices that are fixed (non-removable) palatal expanders used on adults to remodel the jaw or to treat conditions. The …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 28, 2023 - 04:00 GMT

Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical Solution Hand ...

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 March 23, 2023 - 17:22 GMT

Risks with Exactech Joint Replacement Devices with Defective Packaging – FDA Safety Communication

Date Issued: March 23, 2023 The U.S. Food and Drug Administration (FDA) is reminding patients and health care providers about Exactech joint replacement devices manufactured by Exactech between 2004 and August 2021, and recalled in 2021 and 2022. Many …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 22, 2023 - 19:28 GMT

Ascend Laboratories LLC. Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, Due to the ...

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 March 17, 2023 - 17:31 GMT

Datascope/Getinge Recalls Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown ...

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: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 10, 2023 - 20:15 GMT

Baxter Issues Urgent Medical Device Correction for LIFE2000 Ventilation System Due to Potential for Patient Desaturation When ...

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 …

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Published on March 10, 2023 - 10:17 GMT

KVK-Tech, Inc. Issues Voluntary Nationwide Recall of One Lot of Betaxolol Tablets, USP 10 mg (Batch Number: 17853A) as a ...

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 March 8, 2023 - 14:36 GMT

UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication

Date Issued: March 8, 2023 The U.S. Food and Drug Administration (FDA) is providing an update on reports of squamous cell carcinoma (SCC) in the scar tissue (capsule) that forms around breast implants. Previously, on September 8, 2022, the FDA released a …

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Published on March 7, 2023 - 18:19 GMT

Update: Potential Risk of Exposure to Toxic Compounds When Using Hemodialysis and Peritoneal Dialysis Systems – Letter to Health ...

March 7, 2023 The U.S. Food and Drug Administration (FDA) is continuing to evaluate the potential risk of exposure to toxic compounds when using dialysis systems. On May 6, 2022, the FDA issued a Letter to Health Care Providers about the evaluation of the …

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Published on March 4, 2023 - 21:58 GMT

Abbott Issues Safety Notification for FreeStyle Libre® Family of Readers in the U.S.

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 March 3, 2023 - 23:59 GMT

Pharmedica USA LLC Issues Voluntary Worldwide Recall of Purely Soothing 15% MSM Drops Due to Non-Sterility

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 March 3, 2023 - 23:11 GMT

All Allergenic Extracts for Diagnosis of Food Allergy: FDA Safety Communication - FDA Requires Warning about Anaphylaxis Following ...

[Posted 03/03/2023] AUDIENCE: Allergy and Immunology, Pediatrics, Health Professional, Patient ISSUE: In 2022, during safety monitoring of FDA Adverse Event Reporting System (FAERS) data, FDA became aware of increased postmarketing adverse event …

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Published on February 27, 2023 - 20:07 GMT

Abbott Trifecta Valves: Potential Risk of Early Structural Valve Deterioration- Letter to Health Care Providers

February 27, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, including the Trifecta Valve and the Trifecta Valve with …

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Published on February 27, 2023 - 16:10 GMT

ACTUALIZACIÓN: Uso del Dispositivo Renuvion/J-Plasma para determinados procedimientos estéticos: Comunicado de seguridad de la FDA

English ACTUALIZACIÓN - 27 de febrero de 2023 – El 23 de febrero de 2023, la Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) autorizó el Renuvion APR Handpiece para la administración de energía de radiofrecuencia y …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 24, 2023 - 21:16 GMT

Global Pharma Healthcare Issues Voluntary Nationwide Recall of Delsam Pharma Artificial Eye Ointment Due to Possible Microbial ...

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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