US FDA News: FDA Advisory Panel Recommendations on Lifelong Surveillance and Long-Term Postmarket Data Collection for Patients with AAA Endovascular Aortic Repair – Letter to Health Care Providers

Regular clinical follow-up and imaging is critical to detect EVAR device and treatment failures.
Read more: FDA Advisory Panel Recommendations on Lifelong Surveillance and Long-Term Postmarket Data Collection for Patients with AAA Endovascular Aortic Repair – Letter to Health Care Providers

US FDA News: FDA Roundup: February 25, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: February 25, 2022

US FDA News: Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety Communication

FDA reminds the public and health care providers that results from currently authorized SARS-CoV-2 antibody tests should not be used to evaluate a person’s level of immunity from COVID-19 at any time, and especially after the person received a COVID-19 vaccination.
Read more: Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety Communication

US FDA News: FDA Approves Treatment for Wider Range of Patients with Heart Failure

The FDA approved a drug to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. The approval will provide a treatment option for a wider range of patients with heart failure.
Read more: FDA Approves Treatment for Wider Range of Patients with Heart Failure

US FDA News: Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Percutaneous Thrombolytic Device Due to Risk of Tip Damage During Use

Arrow International, LLC is recalling its Arrow-Trerotola Percutaneous Thrombolytic Device due to potential tip damage during use.


Read more: Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Percutaneous Thrombolytic Device Due to Risk of Tip Damage During Use

US FDA News: FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse

FDA authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse.
Read more: FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse

US FDA News: FDA Roundup: February 22, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: February 22, 2022

US FDA News: Family Dollar Stores Issues Voluntary Recall of Certain FDA-Regulated Products in Six States Including Drugs, Devices, Cosmetics, Foods

Family Dollar,
Inc. is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and shipped to 404 stores from Family Dollar Distribution Center 202 in West Memphis, Arkansas from January 1, 2021 through the pre
Read more: Family Dollar Stores Issues Voluntary Recall of Certain FDA-Regulated Products in Six States Including Drugs, Devices, Cosmetics, Foods

US FDA News: FDA Alerts the Public to Potentially Contaminated Products from Family Dollar Stores in Six States

Today, the FDA is alerting the public that several categories of FDA-regulated products purchased from Family Dollar stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee may be unsafe for consumers to use.
Read more: FDA Alerts the Public to Potentially Contaminated Products from Family Dollar Stores in Six States

US FDA News: FDA Roundup: February 18, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: February 18, 2022

US FDA News: Baxter Issues Urgent Safety Communication to Reinforce Important Safety Information Regarding Upstream Occlusion Alarms for all Spectrum V8 and Spectrum IQ Infusion Pumps

Baxter International Inc. announced today it has issued an Urgent Safety Communication to reinforce important safety information regarding upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusion pumps. Incorrect administration set setup and/or incomplete resolution of upstream occlusi
Read more: Baxter Issues Urgent Safety Communication to Reinforce Important Safety Information Regarding Upstream Occlusion Alarms for all Spectrum V8 and Spectrum IQ Infusion Pumps

US FDA News: BASE10 Genetics Recalls RNAstill MTM Specimen Collection Kits That Are Not Authorized, Cleared, or Approved by the FDA, May Give False Results, and Require Special Training for Safe Handling

BASE10 Genetics RNAstill MTM specimen collection kits are being recalled because they are not FDA-authorized, -cleared, or -approved for use.
Read more: BASE10 Genetics Recalls RNAstill MTM Specimen Collection Kits That Are Not Authorized, Cleared, or Approved by the FDA, May Give False Results, and Require Special Training for Safe Handling

US FDA News: E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results

E25Bio COVID-19 Direct Antigen Rapid Tests are being recalled because they are not authorized, cleared, or approved for use by the FDA.
Read more: E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results

US FDA News: FDA Warns Consumers Not to Use Certain Powdered Infant Formula Produced in Abbott Nutrition’s Facility in Sturgis, Michigan

The FDA, along with the CDC and our state and local partners, is investigating complaints of Cronobacter and Salmonella illnesses related to Similac powdered infant formula.
Read more: FDA Warns Consumers Not to Use Certain Powdered Infant Formula Produced in Abbott Nutrition’s Facility in Sturgis, Michigan

US FDA News: Vyaire Medical Recalls bellavista 1000 and 1000e Series Ventilators Due to Issues with Software Configurations

There is an issue with bellavista 1000 and 1000e ventilators with software version 6.0.1600.0 or higher installed and have the Data Communication port set to “HL7."
Read more: Vyaire Medical Recalls bellavista 1000 and 1000e Series Ventilators Due to Issues with Software Configurations

US FDA News: TCP HOT Acquisition LLC dba HRB Brands Issues Voluntary Nationwide Recall of Sure and Brut Aerosol Sprays Due to the Presence of Benzene

Westport, Connecticut, TCP HOT Acquisition LLC dba HRB Brands is voluntarily recalling all lot numbers with expiration dates on or before August 2023 of the Sure and Brut Aerosol Sprays listed in the table below to the consumer level due to the presence of benzene. While benzene is not an ingredient
Read more: TCP HOT Acquisition LLC dba HRB Brands Issues Voluntary Nationwide Recall of Sure and Brut Aerosol Sprays Due to the Presence of Benzene

US FDA News: FDA Roundup: February 15, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: February 15, 2022

US FDA News: FDA Roundup: February 11, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: February 11, 2022

US FDA News: Coronavirus (COVID-19) Update: FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant

The FDA issued an emergency use authorization for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant.
Read more: Coronavirus (COVID-19) Update: FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant

US FDA News: Coronavirus (COVID-19) Update: FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

The FDA is postponing the Feb. 15 Vaccines and Related Biological Products Advisory Committee meeting given new data that have recently emerged regarding Pfizer’s emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age.
Read more: Coronavirus (COVID-19) Update: FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

US FDA News: Positive-Health Issues Voluntary Nationwide Recall of RISE UP RED EDITION Capsules Due to the Presence of Undeclared Tadalafil

Wilmington DE, Positive-Health is voluntarily recalling lot number 48658908 with Expiry 9/9/23 of Rise Up Red Edition Capsules packaged in 10-count blisters packaged in a carton to the consumer level. Positive-Health was notified by Amazon that laboratory analysis has found the product to be tainted
Read more: Positive-Health Issues Voluntary Nationwide Recall of RISE UP RED EDITION Capsules Due to the Presence of Undeclared Tadalafil

US FDA News: FDA Takes Steps Aimed at Fostering Development of Non-Addictive Alternatives to Opioids for Acute Pain Management

The U.S Food and Drug Administration issued a draft guidance to provide recommendations to companies developing non-opioid analgesics for acute pain lasting up to 30 days, typically in response to some form of tissue injury, such as trauma or surgery.
Read more: FDA Takes Steps Aimed at Fostering Development of Non-Addictive Alternatives to Opioids for Acute Pain Management

US FDA News: Celebrate Today Issues Voluntary Nationwide Recall of One Lot of Red Mammoth Due to the Presence of Undeclared Sildenafil and Tadalafil

Brentwood, NY, Celebrate Today is voluntarily recalling lot number DK1027, Exp 08/01/2023 of Red Mammoth capsules to the consumer level. Celebrate Today was informed by Amazon that laboratory analysis has found the product to be tainted with sildenafil and tadalafil, an ingredients known as a phosph
Read more: Celebrate Today Issues Voluntary Nationwide Recall of One Lot of Red Mammoth Due to the Presence of Undeclared Sildenafil and Tadalafil

US FDA News: FDA Roundup: February 8, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: February 8, 2022

US FDA News: Potential Risk of Strangulation in Children who Use Enteral Feeding Delivery Sets

The FDA is warning health care providers, parents and caregivers that there is a risk of strangulation in children who use enteral feeding delivery sets.
Read more: Potential Risk of Strangulation in Children who Use Enteral Feeding Delivery Sets

US FDA News: ABC SALES 1 INC Issues Voluntary Nationwide Recall of MAC DADDY RED and MAC DADDY PURPLE Capsules Due to the Presence of Undeclared Sildenafil and Tadalafil

ABC SALES 1 INC is voluntarily recalling MAC DADDY RED Capsules, Lot 1230004, Exp 03/30/2024 and MAC DADDY PURPLE Capsules, Lot 1230005, Exp 03/30/2024 to the consumer level. ABC Sales 1 Inc was informed by Amazon that laboratory analysis found MAC DADDY RED capsules to be tainted with sildenafil an
Read more: ABC SALES 1 INC Issues Voluntary Nationwide Recall of MAC DADDY RED and MAC DADDY PURPLE Capsules Due to the Presence of Undeclared Sildenafil and Tadalafil

US FDA News: Your Favorite Shop Issues Voluntary Nationwide Recall of the Red Pill Capsules, Due to the Presence of Undeclared Tadalafil

Your Favorite Shop is voluntarily recalling lot # 26436989. Expiry 10/30/2023 of The Red Pill, packaged in 10-count blisters packaged in a carton to the consumer level. Your Favorite Shop was notified by Amazon that laboratory analysis has found the product to be tainted with tadalafil, an ingredien
Read more: Your Favorite Shop Issues Voluntary Nationwide Recall of the Red Pill Capsules, Due to the Presence of Undeclared Tadalafil

US FDA News: FDA Sodium Reduction Efforts Underscored in USDA’s Transitional Nutrition Standards for School Meals

FDA Sodium Reduction Efforts Underscored in USDA’s Transitional Nutrition Standards for School Meals
Read more: FDA Sodium Reduction Efforts Underscored in USDA’s Transitional Nutrition Standards for School Meals

US FDA News: SD BIOSENSOR, Issues Notification of Voluntary Recall of ‘STANDARD Q COVID-19 Ag Home Test’

Biosensor, Inc., a global in-vitro diagnostics company, is voluntarily recalling its STANDARD Q COVID-19 Ag Home Test in the United States, due to confirmed reports that the test kits were illegally imported into the United States. The STANDARD Q COVID-19 Ag Home Test is not authorized, cleared or a
Read more: SD BIOSENSOR, Issues Notification of Voluntary Recall of ‘STANDARD Q COVID-19 Ag Home Test’

US FDA News: FDA Roundup: February 4, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: February 4, 2022

US FDA News: Vyaire Medical Issues Voluntary Correction for Certain bellavista™ Ventilators in Specific Software Configurations

In December 2021, imtmedical ag, a subsidiary of Vyaire Medical, initiated a voluntary field correction for certain bellavista™ ventilators. With specific software version and configuration combinations, the ventilators can cease ventilation and generate a technical failure alarm 305. There is a pot
Read more: Vyaire Medical Issues Voluntary Correction for Certain bellavista™ Ventilators in Specific Software Configurations

US FDA News: Junp LLC Issues Voluntary Nationwide Recall of MegMan Performance Booster Capsules Due to the Presence of Tadalafil

Brooklyn, NY Junp LLC is voluntarily recalling Lot number 2010291, Exp Date: 01/07/2024 of MegMan Performance Booster capsules, packaged in 10-count blisters packaged in a carton to the consumer level. Junp LLC was notified by Amazon that laboratory analysis has found the product to be tainted wit
Read more: Junp LLC Issues Voluntary Nationwide Recall of MegMan Performance Booster Capsules Due to the Presence of Tadalafil

US FDA News: Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication

The FDA is warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test. The FDA is concerned about the risk of false results when using this test.
Read more: Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication

US FDA News: Ukoniq (umbralisib): Drug Safety Communication - FDA Investigating Possible Increased Risk of Death with Lymphoma

The FDA is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib) approved to treat two specific types of lymphomas, which are cancers that affect the body’s immune system.
Read more: Ukoniq (umbralisib): Drug Safety Communication - FDA Investigating Possible Increased Risk of Death with Lymphoma

US FDA News: FDA Approves First Generic of Restasis

The U.S. Food and Drug Administration today approved an application for the first generic of Restasis (cyclosporine ophthalmic emulsion) eye drops to increase tear production.
Read more: FDA Approves First Generic of Restasis

US FDA News: Esupplementsales, LLC Issues a Nationwide Recall of One Lot of Hard Dawn Due to the Presence of Undeclared Tadalafil

Orangevale, CA, Esupplementsales, LLC is voluntarily recalling lot number 2107 of Hard Dawn Rise and Shine capsules to the consumer level. Esupplementsales, LLC was informed by Amazon that laboratory analysis has found the product to be tainted with tadalafil, an ingredient known as a phosphodieste
Read more: Esupplementsales, LLC Issues a Nationwide Recall of One Lot of Hard Dawn Due to the Presence of Undeclared Tadalafil

US FDA News: Coronavirus (COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

FDA announced a virtual meeting of its Vaccines and Related Biological Products Advisory Committee on Feb. 15 to discuss the request for emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.
Read more: Coronavirus (COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age

US FDA News: FDA Roundup: February 1, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: February 1, 2022