FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on January 27, 2021 - 05:00 GMT

Meitheal Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Cisatracurium Besylate Injection, USP 10mg per 5mL 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 January 26, 2021 - 00:14 GMT

Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-...

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 January 12, 2021 - 15:25 GMT

UPDATE: Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices - Letter to Health Care ...

December 1, 2021 The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics’ Precice devices made from stainless steel and titanium. Today, the FDA is providing …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 12, 2021 - 13:19 GMT

August 7, 2019 UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents ...

December 2, 2021 Update: The FDA launched a new web page about paclitaxel-coated balloons and paclitaxel-eluting stents that are approved to treat obstructed lesions in arteries of the legs. The new web page includes: Paclitaxel-coated balloons and stents …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 11, 2021 - 18:46 GMT

Boston Scientific Announces LOTUS Edge™ Aortic Valve System Voluntary Recall and Product Discontinuation

Summary Company Announcement Date: January 11, 2021 FDA Publish Date: January 11, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Delivery System Issues Potential inability to release the delivery system Company Name: …

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Published on January 10, 2021 - 16:22 GMT

Bayer Issues Voluntary Recall of Specific Lotrimin® and Tinactin® Spray Products Due to the Presence of Benzene

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 January 9, 2021 - 01:30 GMT

Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate ...

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 January 8, 2021 - 18:21 GMT

Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 - Letter to ...

January 8, 2021 The SARS-CoV-2 virus can mutate over time, resulting in genetic variation in the population of circulating viral strains. The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 7, 2021 - 17:48 GMT

Ardil Comercial Issues Voluntary Nationwide Recall of Limar Hand Sanitizer Packaged in 4 oz Bottles Because They Resemble Drink ...

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 January 7, 2021 - 16:18 GMT

Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries. Recalled Product LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Lot codes: LeadCare II: 2013M, 2014M, 2015M, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 7, 2021 - 13:31 GMT

Teva Initiates Voluntary Nationwide Recall of One Lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) Due to Presence of Particulate ...

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 January 5, 2021 - 01:00 GMT

Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-...

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 January 4, 2021 - 20:36 GMT

2021 Safety Communications

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. 2021 Safety Communications Content current as of: 01 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 4, 2021 - 20:35 GMT

Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication

Date Issued: January 4, 2021 The U.S. Food and Drug Administration (FDA) is alerting patients and health care providers of the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test. Risks to a patient of a false …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 4, 2021 - 18:02 GMT

Essaar Inc. Issues Voluntary Nationwide Recall of Rubbing Alcohol Contaminated with Methanol

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 January 4, 2021 - 10:47 GMT

Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers

April 1, 2021 The U.S. Food and Drug Administration (FDA) wants to raise awareness among health care providers, including those working in reprocessing units in health care facilities, about the risk of infections associated with reprocessed urological …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 3, 2021 - 10:38 GMT

Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or Failed Restart After the Pump is Stopped

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 (Include the following information) HVAD Pump Implant Kits for the HeartWare HVAD System RMS ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on January 2, 2021 - 01:34 GMT

Precision Dose, Inc. Issues Voluntary Nationwide Recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL 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 29, 2020 - 14:24 GMT

UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication

Date issued: December 29, 2020 The U.S. Food and Drug Administration (FDA) is updating our February 2020 safety communication on laparoscopic power morcellators to provide new information on the safe and effective use of laparoscopic power morcellation for …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 29, 2020 - 01:16 GMT

Sunstar Americas Inc. Expands Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to ...

Summary Company Announcement Date: December 28, 2020 FDA Publish Date: December 28, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential contamination with Burkholderia lata Company Name: Sunstar Americas, Inc. Brand Name: …

Distribution channels: Healthcare & Pharmaceuticals Industry