FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on March 27, 2021 - 05:31 GMT

Namoo Enterprise LLC Issues Voluntary Nationwide Recall of PremierZen Black 5000 Due to the Presence of Undeclared Sildenafil and ...

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 26, 2021 - 01:01 GMT

S&B Shopper LLC Issues Voluntary Nationwide Recall of Imperial Extreme 2000mg Due to Presence of Undeclared Sildenafil and ...

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 25, 2021 - 15:15 GMT

BD Expands Voluntary Recall of ChloraPrep™ 3 mL Applicator Nationwide to Include All U.S. States

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 25, 2021 - 15:15 GMT

Durisan Hand Sanitizer Recall Due to Microbial Contamination

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 25, 2021 - 15:15 GMT

Benzedrex (propylhexedrine): Drug Safety Communication - FDA Warns that Abuse and Misuse of the Nasal Decongestant Causes Serious ...

[Posted 03/25/2021] AUDIENCE: Consumer, Patient, Health Professional, Pharmacy ISSUE: The FDA is warning that the abuse and misuse of the over-the-counter (OTC) nasal decongestant propylhexedrine can lead to serious harm such as heart and mental health …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 25, 2021 - 15:15 GMT

Zydus Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection, 50 mg/mL Due to Crystallization

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 24, 2021 - 22:10 GMT

Medtronic Recalls Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface for Possible High Levels of ...

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 Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface Model BBP241 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 24, 2021 - 22:10 GMT

Alembic Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Telmisartan Tablets, USP, 20 mg Due to Label Mix-Up

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 18, 2021 - 21:21 GMT

ACIST Recalls Kodama Intravascular Ultrasound Catheter Due to Risk of Broken O-Ring Pieces Flushing into Arteries During Use

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 ACIST Kodama Intravascular Ultrasound Catheter Lots: 00233370, 00233371, 00233372, 00233373, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 17, 2021 - 17:10 GMT

PNHC, LLC d/b/a Heal the World Issues Voluntary Nationwide Recall of Heal the World Hand Sanitizer Packaged in 9.6 Ounce Bottles ...

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 15, 2021 - 22:12 GMT

Risk of Device Component Breaking in Patients with Stryker’s STAR Ankle: FDA Safety Communication

Date Issued: March 15, 2021 The U.S. Food and Drug Administration (FDA) is advising patients, caregivers, and health care providers about the higher than expected risk of the polyethylene (plastic) component of the device breaking (fracture), as early as …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 12, 2021 - 20:15 GMT

Combat Medical Systems, LLC, Recalls Valkyrie LTOWB Collection, Valkyrie LTOWB Administration, Low Titer Type O FWB Transfusion ...

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 Products Combat Medical Convenience Kits: Valkyrie LTOWB Collection and Administration Models: 80-820, NSN …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 12, 2021 - 20:15 GMT

Potential for False Results with Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test for use on cobas Liat System-...

The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff, point-of-care (POC) facility staff, and health care providers that false positive results can occur with the Roche Molecular Systems, Inc. (Roche) cobas SARS-CoV-2 & …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 12, 2021 - 13:51 GMT

Arrow International Inc Recalls Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7Fr, Due to Risk of ...

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 Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7Fr Product Codes and Lot …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 12, 2021 - 05:38 GMT

Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Phenylephrine Hydrochloride Injection, USP, 10 mg/mL 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 March 10, 2021 - 05:52 GMT

Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Spironolactone 25 mg and 50 mg Tablets Due to Mislabeling with 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 View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 8, 2021 - 14:20 GMT

Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to ...

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 V60 Plus ventilators and all V60 ventilators upgraded to enable High Flow Therapy (software version …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 6, 2021 - 08:47 GMT

Stop New Implants of the Medtronic HVAD System – Letter to Health Care Providers

June 3, 2021 The U.S. Food and Drug Administration (FDA) is alerting health care providers that Medtronic has stopped the sale and distribution of the Heartware Ventricular Assist Device (HVAD) System because: There is an increased risk of neurological …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 6, 2021 - 04:48 GMT

Improper Use of Thermal Imaging Devices: FDA Safety Communication

Date Issued: March 4, 2021 The U.S. Food and Drug Administration (FDA) is alerting consumers, health care providers and other users of thermal imaging systems intended to measure human body temperature that improper use of these systems may provide …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on February 24, 2021 - 04:42 GMT

Medtronic Announces Voluntary Recall of Unused Valiant Navion™ Thoracic Stent Graft System

Summary Company Announcement Date: February 23, 2021 FDA Publish Date: February 23, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to endoleaks, stent fractures and stent ring enlargement Company Name: Medtronic …

Distribution channels: Healthcare & Pharmaceuticals Industry