US FDA News: FDA Roundup: October 28, 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: October 28, 2022

US FDA News: 2022 Letters to Health Care Providers

The FDA posts letters to health care providers about the safe use of medical devices.
Read more: 2022 Letters to Health Care Providers

US FDA News: Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers

The FDA is evaluating the potential risk of exposure to toxic compounds when using certain Fresenius Medical Care hemodialysis machines
Read more: Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers

US FDA News: Mylan Institutional LLC, a Viatris Company, Issues a Voluntary Recall of One Lot of Octreotide Acetate Injection, 500 mcg/mL, Due to Glass Particulates in a Syringe

Mylan Institutional LLC, a Viatris company, is voluntarily recalling lot AJ21002, exp 3/2024, of Octreotide Acetate Injection, 500 mcg/mL, packaged in a carton of ten 1mL syringes. This lot is being recalled at the user (hospital/pharmacy) level due to a product complaint of the presence of glass pa
Read more: Mylan Institutional LLC, a Viatris Company, Issues a Voluntary Recall of One Lot of Octreotide Acetate Injection, 500 mcg/mL, Due to Glass Particulates in a Syringe

US FDA News: FDA Roundup: October 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: October 25, 2022

US FDA News: Do Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of Injury: FDA Safety Communication

Do not to use the recalled Mighty Bliss electric heating pads due to the risks of injury, including electric shocks, skin burns, rashes or irritation.
Read more: Do Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of Injury: FDA Safety Communication

US FDA News: Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Recall of Two (2) Lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, Due to the Detection of N-Nitroso Quinapril Impurity

East Windsor, New Jersey, Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two (2) lots (refer table below) of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg, to the consumer level from the US market due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N
Read more: Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Recall of Two (2) Lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, Due to the Detection of N-Nitroso Quinapril Impurity

US FDA News: Whele LLC Announces National Voluntary Recall of Mighty Bliss Electric Heating Pad Due to Product Safety Concerns

Boston, MA, October 18, 2022 / PRNewswire / – Whele LLC, of Boston, MA, is voluntarily recalling its Mighty Bliss Electric Heating Pad, due to product safety concerns. Use of this product may lead to burns, mild shocks, or rashes/irritation
Read more: Whele LLC Announces National Voluntary Recall of Mighty Bliss Electric Heating Pad Due to Product Safety Concerns

US FDA News: Baxter Issues Urgent Medical Device Correction Regarding Potential Radio Frequency Interference With Other Devices Near Beds Installed With WatchCare System

Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the WatchCare Incontinence Management System due to potential for radio frequency (RF) interference with other medical devices. The WatchCare system is designed to discreetly alert the caregiver of an inc
Read more: Baxter Issues Urgent Medical Device Correction Regarding Potential Radio Frequency Interference With Other Devices Near Beds Installed With WatchCare System

US FDA News: FDA Roundup: October 21, 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: October 21, 2022

US FDA News: Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices

Certain Philips Respironics masks for BiPAP and CPAP machines are recalled due to a risk that their magnetic clips may interact with other medical devices.
Read more: Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices

US FDA News: FDA Roundup: October 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: October 18, 2022

US FDA News: FDA, DOJ Seek Permanent Injunctions Against Six E-cigarette Manufacturers

DOJ, on behalf of FDA filed complaints for permanent injunctions against six e-cigarette manufacturers.
Read more: FDA, DOJ Seek Permanent Injunctions Against Six E-cigarette Manufacturers

US FDA News: FDA Awards 19 Grants and Two Contracts Related to Rare Diseases, including ALS

FDA Awards 19 Grants and Two Contracts Related to Rare Diseases, including ALS
Read more: FDA Awards 19 Grants and Two Contracts Related to Rare Diseases, including ALS

US FDA News: FDA Roundup: October 14, 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: October 14, 2022

US FDA News: Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton Due to Vial Breakage

Risk Statement: The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. Exela has received five (5) reports of flying glass injuring skin, eye and/or other parts. There have been no reports of sterility failur
Read more: Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton Due to Vial Breakage

US FDA News: Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid Test Devices That Are Not Authorized, Cleared, or Approved by the FDA

Jiangsu Well Biotech is recalling COVID-19 Ag Rapid Test Devices because they are not authorized, cleared, or approved by the FDA.
Read more: Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid Test Devices That Are Not Authorized, Cleared, or Approved by the FDA

US FDA News: Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups

The FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups.
Read more: Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups

US FDA News: FDA Roundup: October 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: October 11, 2022

US FDA News: FDA Roundup: October 7, 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: October 7, 2022

US FDA News: FDA Approves Vaccine for Use During Third Trimester of Pregnancy to Prevent Whooping Cough in Infants Younger Than Two Months of Age

The FDA approved Boostrix for immunization during the third trimester of pregnancy to prevent pertussis, commonly known as whooping cough, in infants younger than two months of age.
Read more: FDA Approves Vaccine for Use During Third Trimester of Pregnancy to Prevent Whooping Cough in Infants Younger Than Two Months of Age

US FDA News: New Data Show More Than 2.5 Million U.S. Youth Currently Use E-Cigarettes

The FDA and CDC released federal data from the 2022 National Youth Tobacco Survey (NYTS) on e-cigarette use among U.S. youth. Additionally, the FDA sent a warning letter to Puff Bar and marketing denial orders for 32 Hyde e-cigarettes.
Read more: New Data Show More Than 2.5 Million U.S. Youth Currently Use E-Cigarettes

US FDA News: FDA Roundup: October 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: October 4, 2022

US FDA News: FDA Roundup: September 30, 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: September 30, 2022 

US FDA News: FDA Pathway Supports Long-Term Stability, Diversity of Safe and Nutritious Infant Formula Supply in the U.S.

The FDA is continuing, under certain conditions, the flexibilities regarding importation and domestic production of certain infant formula products as part of its effort to provide stable, longer-term access to safe and nutritious infant formula across the country.
Read more: FDA Pathway Supports Long-Term Stability, Diversity of Safe and Nutritious Infant Formula Supply in the U.S.

US FDA News: LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure

The LifeSPARC System is being recalled for risk that users can inadvertently cause extended pump stop when replacing the controller after software malfunction.
Read more: LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure

US FDA News: Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up

Golden State Medical Supply, Incorporated (GSMS, Inc.) - Camarillo, CA has initiated a voluntary recall of the products listed in the table below because a report was received that a bottle containing Clopidogrel 75mg Tablets produced with lot# GS046745 was mislabeled as Atenolol 25mg Tablets. This
Read more: Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up

US FDA News: FDA Approves New Treatment Option for Patients with ALS

The FDA approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease.
Read more: FDA Approves New Treatment Option for Patients with ALS

US FDA News: Proper Trade LLC/My Stellar Lifestyle Issues Voluntary Nationwide Recall of Wonder Pill Capsules Due to the Presence of Undeclared Tadalafil

Proper Trade LLC/My Stellar Lifestyle is voluntarily recalling Wonder Pill lot 20210912 and lot 31853-501
Read more: Proper Trade LLC/My Stellar Lifestyle Issues Voluntary Nationwide Recall of Wonder Pill Capsules Due to the Presence of Undeclared Tadalafil

US FDA News: FDA, Veterans Health Administration Collaborate to Help Accelerate Medical Device Innovation and Advancement of Care

FDA and the Veterans Health Administration (VHA) are announcing a collaboration intended to help accelerate American medical device innovation to further improve and benefit public health.
Read more: FDA, Veterans Health Administration Collaborate to Help Accelerate Medical Device Innovation and Advancement of Care

US FDA News: FDA Proposes Updated Definition of ‘Healthy’ Claim on Food Packages to Help Improve Diet, Reduce Chronic Disease

FDA Proposes Updated Definition of ‘Healthy’ Claim on Food Packages to Help Improve Diet, Reduce Chronic Disease
Read more: FDA Proposes Updated Definition of ‘Healthy’ Claim on Food Packages to Help Improve Diet, Reduce Chronic Disease

US FDA News: FDA Roundup: September 27, 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: September 27, 2022

US FDA News: Eugia US LLC Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), Due to the Presence of Particulate Matter

East Windsor, New Jersey, Eugia US LLC (formerly AuroMedics Pharma LLC) has initiated a voluntary recall of lot number AC22006 of AuroMedics Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), 10 mL single dose vial to the consumer level from the U.S. market due to a product complaint for the pr
Read more: Eugia US LLC Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection 500 mg per 10 mL (50 mg/mL), Due to the Presence of Particulate Matter

US FDA News: Coronavirus (COVID-19) Update: FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types

The FDA updated its COVID-19 test policy to ensure continued access to tests while encouraging the transition of these important public health tools to traditional premarket review pathways.
Read more: Coronavirus (COVID-19) Update: FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types

US FDA News: FDA Roundup: September 23, 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: September 23, 2022

US FDA News: Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern

Certain Philips Respironics BiPAP machines are recalled due to a plastic issue that may expose patients to certain chemicals of concern.
Read more: Philips Respironics Recalls Certain BiPAP Machines for Plastic Issue that May Expose Patients to Certain Chemicals of Concern

US FDA News: New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials

The FDA issued draft guidance that, when finalized, will provide the agency’s perspective on the ethical considerations for including and protecting children in clinical trials and will assist industry, sponsors and IRBs when considering the enrollment of children.
Read more: New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials

US FDA News: FDA Roundup: September 20, 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: September 20, 2022

US FDA News: FDA Concludes Internal Review of Agency Actions Related to the U.S. Infant Formula Supply

Today, the FDA released a review of review activities and decision-making related to the shutdown of Abbott’s Sturgis, Michigan, infant formula facility.
Read more: FDA Concludes Internal Review of Agency Actions Related to the U.S. Infant Formula Supply

US FDA News: Salon Technologies, Inc. Issues Voluntary Nationwide Recall of Antica Ocean Citron Hand Sanitizer ( Alcohol ) Gel 65% Due to the Presence of Benzene

Orlando, Florida. Salon Technologies International. Inc. is voluntarily recalling one lot of Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%, Lot 1166A. Expiration 6/18/2023 to the consumer level. Firm lab testing has found the product to contain benzene. Benzene is classified as a human carci

Read more: Salon Technologies, Inc. Issues Voluntary Nationwide Recall of Antica Ocean Citron Hand Sanitizer ( Alcohol ) Gel 65% Due to the Presence of Benzene

US FDA News: FDA Roundup: September 16, 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: September 16, 2022

US FDA News: Voluntary Recall of Certain Over-the-Counter Products Sold at Family Dollar Stores Because They Were Stored Outside of Temperature Requirements

Family Dollar 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 inadvertently shipped to certain stores on or around May 1, 2022 through June 10, 2022 due to product being stored outside of labeled
Read more: Voluntary Recall of Certain Over-the-Counter Products Sold at Family Dollar Stores Because They Were Stored Outside of Temperature Requirements

US FDA News: Voluntary Recall of Certain Colgate Products Sold at Family Dollar Stores Because They Were Stored Outside of Temperature Requirements

Family Dollar 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 a limited number of stores in AZ, CA, GA, ID, IN, MT, NM, NV, OR, TX, and UT on or around May 1, 2022 through June 21, 202
Read more: Voluntary Recall of Certain Colgate Products Sold at Family Dollar Stores Because They Were Stored Outside of Temperature Requirements

US FDA News: Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube for Risk of Airway Obstruction

The NIM CONTACT and Standard Reinforced EMG Endotracheal Tubes may obstruct the patient’s airway.
Read more: Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube for Risk of Airway Obstruction

US FDA News: Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

The FDA is informing patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy that must be considered.
Read more: Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

US FDA News: Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set with Duovent for Risk of Leaks That May Expose Providers and Patients to Hazardous / Toxic Substances

The Clearlink Basic Solution Set with Duovent may begin to leak, which poses risk of serious injury or death.


Read more: Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set with Duovent for Risk of Leaks That May Expose Providers and Patients to Hazardous / Toxic Substances

US FDA News: FDA and NIH Launch Public-Private Partnership for Rare Neurodegenerative Diseases

FDA and NIH launch Critical Path for Rare Neurodegenerative Diseases – a public-private partnership aimed at advancing the understanding of rare neurodegenerative diseases and fostering the development of treatments.
Read more: FDA and NIH Launch Public-Private Partnership for Rare Neurodegenerative Diseases

US FDA News: FDA Roundup: September 13, 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: September 13, 2022

US FDA News: FDA Roundup: September 9, 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: September 9, 2022

US FDA News: FDA Issues Safety Alert for Squamous Cell Carcinoma and Various Lymphomas in Scar Tissue around Breast Implants

Today, the FDA issued a safety communication about reports of SCC and various lymphomas in the capsule or scar tissue around breast implants.
Read more: FDA Issues Safety Alert for Squamous Cell Carcinoma and Various Lymphomas in Scar Tissue around Breast Implants

US FDA News: Abbott MitraClip Device: Potential for Clip Lock Malfunctions - Letter to Health Care Providers

There are reports of clip lock malfunctions before and after clip deployment with the Abbott MitraClip device.
Read more: Abbott MitraClip Device: Potential for Clip Lock Malfunctions - Letter to Health Care Providers

US FDA News: Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication

Reports of squamous cell carcinoma and various lymphomas in capsule around breast implants. Read recommendations for patients and health care providers
Read more: Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication

US FDA News: Monkeypox Update: FDA Takes Significant Action to Help Expand Access to Testing

The FDA issued an EUA, guidance and associated templates today to help expand testing capacity in response to the monkeypox public health emergency (PHE).
Read more: Monkeypox Update: FDA Takes Significant Action to Help Expand Access to Testing

US FDA News: Philips Respironics Alerts Customers Worldwide of Updated Instructions and Labeling of Specific Sleep Therapy Masks That Contain Magnetic Headgear Clips Due to Potential Risk of Serious Injury

Pittsburgh, Pennsylvania – Royal Philips’ (NYSE: PHG; AEX: PHIA) subsidiary Philips Respironics is alerting users of certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps that these devices should not be used by or near patients and their household members, caregivers and
Read more: Philips Respironics Alerts Customers Worldwide of Updated Instructions and Labeling of Specific Sleep Therapy Masks That Contain Magnetic Headgear Clips Due to Potential Risk of Serious Injury

US FDA News: Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices

Today, the U.S. Food and Drug Administration alerted patients, caregivers and health care providers of recalled Philips Respironics masks for BiPAP, CPAP machines.
Read more: Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices

US FDA News: FDA Roundup: September 6, 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: September 6, 2022

US FDA News: Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: Letter to Health Care Providers

Certain Philips masks can cause potential injury or death if magnets interfere with certain implanted metallic medical devices or metallic objects in the body.
Read more: Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: Letter to Health Care Providers

US FDA News: FDA Roundup: September 2, 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: September 2, 2022

US FDA News: FDA Approves First Treatment for Acid Sphingomyelinase Deficiency, a Rare Genetic Disease

The FDA approved Xenpozyme (Olipudase alfa) for intravenous infusion in pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a rare genetic disease that causes premature death.
Read more: FDA Approves First Treatment for Acid Sphingomyelinase Deficiency, a Rare Genetic Disease

US FDA News: Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose

The FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination.
Read more: Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose

US FDA News: FDA Roundup: August 30, 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: August 30, 2022

US FDA News: Hamilton Medical AG Recalls Hamilton-C6 Intensive Care Ventilator Due to Potential Water Ingress that May Cause Breathing Support to Stop

If water enters the Hamilton-C6 Intensive Care Ventilator due to a loose status indicator board, it may cause the ventilator to stop providing breathing support.
Read more: Hamilton Medical AG Recalls Hamilton-C6 Intensive Care Ventilator Due to Potential Water Ingress that May Cause Breathing Support to Stop

US FDA News: Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication

Philips Respironics recalled certain BiPAP machines due to a plastic issue that may release certain chemicals of concern and cause device failure.
Read more: Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication

US FDA News: Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion Pump Due to Faster Than Expected Flow Rates That May Impact Infusion Delivery

The Intera 3000 Hepatic Artery Infusion Pump is being recalled after reports that it has a faster than expected flow rate.
Read more: Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion Pump Due to Faster Than Expected Flow Rates That May Impact Infusion Delivery

US FDA News: FDA Roundup: August 26, 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: August 26, 2022

US FDA News: FDA Removes N95 Respirators from Medical Device Shortage List, Signaling Sufficient Supply

Today, the FDA announced the removal of N95 respirators from the agency’s medical device shortage list.
Read more: FDA Removes N95 Respirators from Medical Device Shortage List, Signaling Sufficient Supply

US FDA News: Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities

The FDA revoked the emergency use authorizations for non-NIOSH-approved disposable respirators and the EUAs for decontamination and bioburden reduction systems.
Read more: Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities

US FDA News: FDA and Mexican Counterparts Report Progress in Food Safety at Second Annual Partnership Meeting

Today, the U.S. Food and Drug Administration and its regulatory counterparts in Mexico COFEPRIS and SENASICA held the second annual Food Safety Partnership Meeting.
Read more: FDA and Mexican Counterparts Report Progress in Food Safety at Second Annual Partnership Meeting

US FDA News: Medtronic Recalls HeartWare HVAD System Batteries for Electrical Faults That Cause Battery Failure

An electrical fault may cause the batteries of the HeartWare HVAD System to fail, leading to severe injury or death.


Read more: Medtronic Recalls HeartWare HVAD System Batteries for Electrical Faults That Cause Battery Failure

US FDA News: FDA Roundup: August 23, 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: August 23, 2022

US FDA News: Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (Containing Benzyl Alcohol), Due To The Potential Presence of Visible Particulates

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion (containing benzyl alcohol), 100mL Single Patient Use Glass Fliptop Vial; lot EA7470, to the user level due to visible particulates observed in two vials during annual examination of retention samples.
Read more: Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (Containing Benzyl Alcohol), Due To The Potential Presence of Visible Particulates

US FDA News: FDA Roundup: August 19, 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: August 19, 2022

US FDA News: Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and Deliver Reduced Energy Shock During High Voltage Therapy

Cobalt/Crome ICDs and CRT-Ds may deliver reduced-energy electric shocks and short circuit protection (SCP) alerts during high voltage therapy.
Read more: Medtronic Recalls Cobalt XT, Cobalt and Crome ICDs and CRT-Ds for Risk that Devices May Issue a Short Circuit Alert and Deliver Reduced Energy Shock During High Voltage Therapy

US FDA News: 2022 Letters to Health Care Providers

The FDA posts letters to health care providers about the safe use of medical devices.
Read more: 2022 Letters to Health Care Providers

US FDA News: FDA Warns Manufacturer for Marketing Illegal Flavored Nicotine Gummies

Today, the U.S. Food and Drug Administration issued a warning letter for marketing illegal flavored nicotine gummies – the first warning letter for this type of product.
Read more: FDA Warns Manufacturer for Marketing Illegal Flavored Nicotine Gummies

US FDA News: FDA Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric Patients with Beta-thalassemia Who Require Regular Blood Transfusions

FDA approves Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy for the treatment of adult and pediatric patients with Beta-thalassemia who require regular red blood cell (RBC) transfusions.
Read more: FDA Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric Patients with Beta-thalassemia Who Require Regular Blood Transfusions

US FDA News: Stop Using Certain Syringes and Needles with Needle Safety Devices Manufactured by Haiou – Letter to Health Care Providers

Certain syringes and needles with needle safety devices manufactured by HAIOU may cause needles to detach in patients’ arms after injection or needle failure.
Read more: Stop Using Certain Syringes and Needles with Needle Safety Devices Manufactured by Haiou – Letter to Health Care Providers

US FDA News: FDA Roundup: August 16, 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: August 16, 2022

US FDA News: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls

Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall
Read more: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls

US FDA News: Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

This update provides additional information on the recall and recommendations for people who use repaired and replaced devices.
Read more: Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

US FDA News: FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans

FDA issues historic final rule to improve access to affordable hearing aids for millions of Americans with perceived mild to moderate hearing impairment.
Read more: FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans

US FDA News: FDA Roundup: August 12, 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: August 12, 2022

US FDA News: At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication

The FDA recommends repeat testing following a negative result to reduce the risk that a COVID-19 infection could be missed, whether or not you have symptoms.
Read more: At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication

US FDA News: Becton Dickinson Recalls Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, and Intraosseous Powered Drivers for Issues That May Cause Delayed Treatment Delivery

Issues with BD Intraosseous needle kits and drivers may prevent treatments from being infused through the bone causing delays in care.
Read more: Becton Dickinson Recalls Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, and Intraosseous Powered Drivers for Issues That May Cause Delayed Treatment Delivery

US FDA News: FDA Infant Formula Update: August 10, 2022

FDA exercises enforcement discretion to Reckitt Nutrition/Mead Johnson Nutrition to import Base Powder for PurAmino Hypoallergenic Infant Formula (amino acid-based infant formula with iron) infant formula products from Mexico following review of nutritional adequacy and safety information, including
Read more: FDA Infant Formula Update: August 10, 2022

US FDA News: Monkeypox Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply

The FDA issued an emergency use authorization (EUA) for the JYNNEOS vaccine to increase vaccine supply by up to five-fold and to allow for individuals under 18 years of age determined to be at high risk of monkeypox infection to receive the vaccine.
Read more: Monkeypox Update: FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply

US FDA News: FDA Roundup: August 9, 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: August 9, 2022

US FDA News: Haimen Shengbang Laboratory Equipment Co. Ltd. Recalls Viral Transport Media Containers That Are Not Authorized, Cleared, or Approved by the FDA

Haimen Shengbang is recalling Viral Transport Media Containers because they were distributed to U.S. customers without FDA authorization, clearance, or approval.
Read more: Haimen Shengbang Laboratory Equipment Co. Ltd. Recalls Viral Transport Media Containers That Are Not Authorized, Cleared, or Approved by the FDA

US FDA News: FDA Issues Warning Letters to Three Companies for Selling Unapproved New Drugs for Mole and Skin Tag Removal

Today, the FDA issued three warning letters to companies for introducing products for mole and skin tag removal into interstate commerce that are unapproved new drugs.
Read more: FDA Issues Warning Letters to Three Companies for Selling Unapproved New Drugs for Mole and Skin Tag Removal

US FDA News: FDA Roundup: August 5, 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: August 5, 2022

US FDA News: FDA Infant Formula Update: August 5, 2022

FDA Infant Formula Update: August 5 Nestlé (The Netherlands)
Read more: FDA Infant Formula Update: August 5, 2022

US FDA News: FDA Approves First Targeted Therapy for HER2-Low Breast Cancer

FDA Approves First Targeted Therapy for HER2-Low Breast Cancer
Read more: FDA Approves First Targeted Therapy for HER2-Low Breast Cancer

US FDA News: VI-Jon, LLC Expands Voluntary Worldwide Recall of All Flavors and Lots within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination

Vi-Jon, LLC is revising a previously reported list of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry
Read more: VI-Jon, LLC Expands Voluntary Worldwide Recall of All Flavors and Lots within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination

US FDA News: Plastikon Healthcare Expands Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination

Plastikon Healthcare, LLC is issuing an update to the voluntary recall initiated on June 3, 2022. The recall has been expanded to include Lot 20076A of Magnesium Hydroxide 1200 mg / Aluminum Hydroxide 1200 mg / Simethicone 120 mg per 30 mL Oral Suspension. This lot was previously subject to a retai
Read more: Plastikon Healthcare Expands Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination

US FDA News: FDA Continues Efforts to Support Innovation in Medical Device Sterilization

The FDA provides updates on its work to promote innovative ways to sterilize medical devices while reducing adverse impacts on the environment and on the public health, but also developing solutions to avoid potential shortages of medical devices.
Read more: FDA Continues Efforts to Support Innovation in Medical Device Sterilization

US FDA News: Distributor RFR, LLC, Voluntary Nationwide Recall of Sangter Energy Supplement Due to Presence of Undeclared Sildenafil

Miami, Florida, DISTRIBUTOR RFR, LLC. is voluntarily recalling lot #48656, Exp. 01/2025 of SANGTER Energy Supplement, 3000 mg, packaged in 7-count blister packs within a carton to the consumer level. FDA analysis has found the product to contain undeclared sildenafil. Sildenafil is a phosphodiestera
Read more: Distributor RFR, LLC, Voluntary Nationwide Recall of Sangter Energy Supplement Due to Presence of Undeclared Sildenafil

US FDA News: FDA Roundup: August 2, 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: August 2, 2022

US FDA News: North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits That Are Not Authorized, Cleared, or Approved by the FDA

North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits because they are not authorized, cleared, or approved by the FDA.
Read more: North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits That Are Not Authorized, Cleared, or Approved by the FDA

US FDA News: Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene

Edgewell Personal Care Company (NYSE: EPC) today issued a voluntary nationwide recall of three batches of Banana Boat Hair & Scalp Sunscreen Spray SPF 30 to the consumer level as outlined in the table below. An internal review found that some samples of the product contained trace levels of benzen
Read more: Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene

US FDA News: FDA Roundup: July 29, 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: July 29, 2022

US FDA News: FDA Infant Formula Update: July 29, 2022

Today, the FDA is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S.
Read more: FDA Infant Formula Update: July 29, 2022

US FDA News: FDA Provides Update on Agency Response to Monkeypox Outbreak

Today, the FDA is providing an update on its multipronged response to monkeypox in the United States, including its efforts in the areas of diagnostics, vaccines and therapeutics.
Read more: FDA Provides Update on Agency Response to Monkeypox Outbreak

US FDA News: Covidien, LLC (Medtronic) Recalls Palindrome and Mahurkar Hemodialysis Catheters Due to Catheter Hub Defect

Covidien, LLC (Medtronic) is recalling Palindrome and Mahurkar hemodialysis catheters due to catheter hub defect.
Read more: Covidien, LLC (Medtronic) Recalls Palindrome and Mahurkar Hemodialysis Catheters Due to Catheter Hub Defect

US FDA News: FDA Seeks to Improve Patient Communication on LASIK Benefits and Risks Through Issuance of Draft Guidance

FDA issues draft guidance to help ensure that information is available to patients and health care professionals to clearly communicate the benefits and risks of LASIK devices.
Read more: FDA Seeks to Improve Patient Communication on LASIK Benefits and Risks Through Issuance of Draft Guidance

US FDA News: FDA Roundup: July 26, 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: July 26, 2022

US FDA News: Vi-Jon, LLC Expands Voluntary Nationwide Recall of All Flavors and Lots Within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination

July 25, 2022 – Smyrna, TN, Vi-Jon, LLC is expanding its voluntary recall to include all lots of all flavors of Magnesium Citrate Saline Laxative Oral Solution within expiry to the consumer level. This expansion includes all lots of Cherry Flavor and Grape Flavor of Magnesium Citrate Saline Laxati
Read more: Vi-Jon, LLC Expands Voluntary Nationwide Recall of All Flavors and Lots Within Expiry of Magnesium Citrate Saline Laxative Oral Solution Due to Microbial Contamination

US FDA News: Ultra Supplement LLC Issues Voluntary Nationwide Recall of Sustango Due to the Presence of Undeclared Tadalafil

Wilmington DE, Ultra Supplement LLC is voluntarily recalling lot number DAP272109, exp 4/1/26 of Sustango capsules packaged in 10-count blisters packaged in a carton to the consumer level. Ultra Supplement was notified by Amazon that laboratory analysis has found the product to be tainted with tadal
Read more: Ultra Supplement LLC Issues Voluntary Nationwide Recall of Sustango Due to the Presence of Undeclared Tadalafil

US FDA News: Baxter Healthcare Corporation Recalls Abacus Order Entry and Calculation Software for Risk of Medication Label Errors

User changes in the Abacus order entry and calculation software labeling templates may cause incorrect information to appear on final medication labels.
Read more: Baxter Healthcare Corporation Recalls Abacus Order Entry and Calculation Software for Risk of Medication Label Errors

US FDA News: FDA Roundup: July 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: July 22, 2022

US FDA News: FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect Public Health

FDA provides draft guidance on remote regulatory assessments for their use and, once finalized, how they will be consistently incorporated for all FDA-regulated products beyond the public health emergency.
Read more: FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect Public Health

US FDA News: UPDATE: The FDA Reminds Patients and Health Care Providers of the Importance of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication

The FDA is updating our October 28, 2019 safety communication on the use of AFX endovascular grafts with Duraply material (AFX with Duraply or AFX2).
Read more: UPDATE: The FDA Reminds Patients and Health Care Providers of the Importance of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication

US FDA News: UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication

Renuvion/J-Plasma device can be used for additional aesthetic skin procedures
Read more: UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication

US FDA News: Voluntary Recall of Certain Over-the-Counter Products

Family Dollar 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 inadvertently shipped to certain stores on or around May 1, 2022 through June 10, 2022 due to product being stored outside of labeled
Read more: Voluntary Recall of Certain Over-the-Counter Products

US FDA News: Smiths Medical Recalls Certain Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Issues That May Impact Infusion Delivery

Software issues affecting certain Medfusion Syringe Infusion Pumps could impact infusion delivery to patients.
Read more: Smiths Medical Recalls Certain Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Issues That May Impact Infusion Delivery

US FDA News: FDA Conducting Evaluation of Key Agency Activities to Strengthen Operations

The FDA is conducting an evaluation of key agency activities to strengthen operations.
Read more: FDA Conducting Evaluation of Key Agency Activities to Strengthen Operations

US FDA News: FDA Roundup: July 19, 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: July 19, 2022

US FDA News: MKS Enterprise LLC Voluntary Recalls of Dose Vital VIP Vital Honey Due to Presence of Undeclared Tadalafil

This product was found to contain the undeclared active pharmaceutical ingredient tadalafil. Tadalafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor, is the active ingredient in an FDA-approved prescription drug, used to treat erectile dysfunction (ED). This undeclared ingredient may intera
Read more: MKS Enterprise LLC Voluntary Recalls of Dose Vital VIP Vital Honey Due to Presence of Undeclared Tadalafil

US FDA News: FDA Roundup: July 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: July 15, 2022

US FDA News: For Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication

Monkeypox testing of saliva, blood, or other sample types may have false results
Read more: For Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication

US FDA News: Vi-Jon, LLC Expands Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination

Smyrna, TN, Vi-Jon, LLC is expanding its voluntary recall to include all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry to the consumer level. The recall was initiated after 3rd Party and Vi-Jon, LLC microbial testing identified the presence of
Read more: Vi-Jon, LLC Expands Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination

US FDA News: FDA Provides Educational Resources for Parents and Caregivers to Support Confidence for Imported Infant Formula Products

The FDA announced the availability of educational resources for parents and caregivers with questions about using the hundreds of millions of bottles worth of imported infant formula headed to the U.S.
Read more: FDA Provides Educational Resources for Parents and Caregivers to Support Confidence for Imported Infant Formula Products

US FDA News: Hospira Issues a Voluntary Nationwide Recall for One Lot of Propofol Injectable Emulsion, USP (Containing Benzyl Alcohol), Due to the Potential Presence of Visible Particulate

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol) to the user level due to a visible particulate observed in a single vial during annual examination of retain samples
Read more: Hospira Issues a Voluntary Nationwide Recall for One Lot of Propofol Injectable Emulsion, USP (Containing Benzyl Alcohol), Due to the Potential Presence of Visible Particulate

US FDA News: Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted

The FDA issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
Read more: Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted

US FDA News: American Contract Systems Recalls COVID Test Kits Nonsterile and Clean Catch Urine Kits for Risk of False Results

COVID testing or specimen kits for urine samples may not give accurate results because they were assembled in an uncontrolled facility by people without proper training.
Read more: American Contract Systems Recalls COVID Test Kits Nonsterile and Clean Catch Urine Kits for Risk of False Results

US FDA News: FDA Warns Four Companies for Selling Tainted Honey-based Products with Hidden Active Drug Ingredients

Today, the FDA issued warning letters to four companies for illegally selling honey-based products that may pose a significant health risk to consumers.
Read more: FDA Warns Four Companies for Selling Tainted Honey-based Products with Hidden Active Drug Ingredients

US FDA News: FDA Infant Formula Update: July 8, 2022

FDA Infant Formula Update: July 8 (Australia)
Read more: FDA Infant Formula Update: July 8, 2022

US FDA News: FDA Roundup: July 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: July 8, 2022

US FDA News: FDA Developing New Framework for Continued, Expanded Access to Infant Formula Options for U.S. Parents and Caregivers

The FDA is developing a new framework for continue and expanded access to infant formula options for U.S. parents and caregivers.
Read more: FDA Developing New Framework for Continued, Expanded Access to Infant Formula Options for U.S. Parents and Caregivers

US FDA News: Coronavirus (COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations

The FDA revised the EUA for Paxlovid to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid
Read more: Coronavirus (COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations

US FDA News: FDA Infant Formula Update: July 6, 2022

FDA Infant Formula Update July 6 Vitaflo (Netherlands)
Read more: FDA Infant Formula Update: July 6, 2022

US FDA News: Mylan Pharmaceuticals Inc., a Viatris Company, Issues Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100), Due to the Potential of Missing Labels on Some Pens

Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens which are packaged in cartons of five pens to the consumer level. This product is not the branded Semglee® pen but the un
Read more: Mylan Pharmaceuticals Inc., a Viatris Company, Issues Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100), Due to the Potential of Missing Labels on Some Pens

US FDA News: Getinge USA Sales Inc Recalls Flow-c and Flow-e Anesthesia Systems for Cracked or Broken Suction System Power Switches

A broken on/off suction switch of the Getinge Flow-c and Flow-e anesthesia systems may prevent fluids from being removed from the patient’s airway.
Read more: Getinge USA Sales Inc Recalls Flow-c and Flow-e Anesthesia Systems for Cracked or Broken Suction System Power Switches

US FDA News: FDA Roundup: July 5, 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: July 5, 2022

US FDA News: FDA Roundup: July 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: July 1, 2022

US FDA News: Information Regarding Medically Necessary Specialty Infant Formulas: Notice to Health Care Providers

The FDA is providing information to health care professionals to help their patients obtain access to medically necessary specialty formulas, the amino acid-based and the metabolic infant formula products.
Read more: Information Regarding Medically Necessary Specialty Infant Formulas: Notice to Health Care Providers

US FDA News: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication

The FDA is alerting patients who had mammograms at Capitol Radiology, LLC in Laurel, Maryland, on or after June 26, 2018, about possible problems with the quality of their mammograms.
Read more: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication

US FDA News: Loud Muscle Science, LLC Issues Voluntary Recall of Launch Sequence Capsules Due to the Presence of Undeclared Tadalafil in United States and Canada

Hauppauge, NY, Loud Muscle Science, LLC is voluntarily recalling the following Launch Sequence products and lots listed in the table below to the consumer level. Laboratory analysis undertaken at the request of Loud Muscle Science, LLC found the products to be tainted with tadalafil, an ingredient i
Read more: Loud Muscle Science, LLC Issues Voluntary Recall of Launch Sequence Capsules Due to the Presence of Undeclared Tadalafil in United States and Canada

US FDA News: Copiktra (duvelisib): Drug Safety Communication - FDA Warns about Possible Increased Risk of Death and Serious Side Effects

FDA is warning that results from a clinical trial show a possible increased risk of death with Copiktra (duvelisib) compared to another medicine to treat a chronic blood cancer.

Read more: Copiktra (duvelisib): Drug Safety Communication - FDA Warns about Possible Increased Risk of Death and Serious Side Effects

US FDA News: FDA Infant Formula Update: June 30, 2022

FDA Infant Formula Update June 30 Danone New Zealand
Read more: FDA Infant Formula Update: June 30, 2022

US FDA News: Update: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication

The FDA is alerting patients who had mammograms at Capitol Radiology, LLC on or after June 26, 2018, about possible problems with the quality of mammograms.
Read more: Update: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication

US FDA News: Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses

The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two component (bivalent) booster vaccine, beginning in Fall 2022.
Read more: Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses

US FDA News: Bryant Ranch Prepack Inc. Issues Voluntary Nationwide Recall of Morphine Sulfate 30 mg Extended Release and Morphine Sulfate 60 mg Extended-Release Due to Label-Mix Up

Burbank, California, Bryant Ranch Prepack Inc. is voluntarily recalling one lot of Morphine Sulfate 30 mg Extended-Release tablets (Comprised of 10 bottles), and one lot of Morphine Sulfate 60 mg Extended-Release tablets (Comprised of 10 bottles) to the consumer level listed in the table below. The
Read more: Bryant Ranch Prepack Inc. Issues Voluntary Nationwide Recall of Morphine Sulfate 30 mg Extended Release and Morphine Sulfate 60 mg Extended-Release Due to Label-Mix Up

US FDA News: FDA Roundup: June 28, 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: June 28, 2022

US FDA News: FDA Infant Formula Update: June 28, 2022

FDA Infant Formula Update June 28 Abbott (Ireland)
Read more: FDA Infant Formula Update: June 28, 2022

US FDA News: Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication

The FDA is warning health care providers, parents and caregivers that there is a risk of death or injury in babies who use neck floats.
Read more: Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication

US FDA News: GE Healthcare Recalls CARESCAPE R860 Ventilator Due to Early Failure of Backup Batteries that May Cause Unexpected Ventilator Shut Down

If a CARESCAPE R860 ventilator is running on backup batteries and the battery fails, the ventilator may suddenly shut down and stop supporting the patient.
Read more: GE Healthcare Recalls CARESCAPE R860 Ventilator Due to Early Failure of Backup Batteries that May Cause Unexpected Ventilator Shut Down

US FDA News: FDA Introduces Innovative Proposal to Advance Consumer Access to Nonprescription Drugs

Today, the FDA issued a proposal to broaden the range of marketed nonprescription drugs available to consumers.
Read more: FDA Introduces Innovative Proposal to Advance Consumer Access to Nonprescription Drugs

US FDA News: FDA Infant Formula Update: June 27, 2022

FDA Infant Formula Update June 27 Bellamy (Australia)
Read more: FDA Infant Formula Update: June 27, 2022

US FDA News: FDA Roundup: June 24, 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: June 24, 2022

US FDA News: Medtronic Recalls HeartWare HVAD System Batteries Due to Battery Failure

The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging.
Read more: Medtronic Recalls HeartWare HVAD System Batteries Due to Battery Failure

US FDA News: Baxter Healthcare Corporation Recalls Volara System For Risk Of Respiratory Distress In Ventilated Patients During Home Use

When the Volara system’s in-line ventilator adaptor is used at home with a ventilator, it may prevent the patient from getting enough oxygen.
Read more: Baxter Healthcare Corporation Recalls Volara System For Risk Of Respiratory Distress In Ventilated Patients During Home Use

US FDA News: BD Announces Voluntary Recall on Intraosseous Products

BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on the BDTM Intraosseous Needle Set Kits, BDTM Intraosseous Manual Driver Kits and BDTM Intraosseous Powered Drivers.
Read more: BD Announces Voluntary Recall on Intraosseous Products

US FDA News: Vi-Jon, LLC Issues Voluntary Nationwide Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination

Vi-Jon, LLC is voluntarily recalling 1 (one) lot of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) to the consumer level. Testing identified the affected lot of the product to contain the bacteria Gluconacetobacter liquefaciens.
Read more: Vi-Jon, LLC Issues Voluntary Nationwide Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination

US FDA News: FDA Infant Formula Update: June 22, 2022

FDA exercises enforcement discretion to Global Kosher to import various Kendamil infant formula products from United Kingdom following review of nutritional adequacy and safety information, including microbiological testing, labeling, facility production and inspection history
Read more: FDA Infant Formula Update: June 22, 2022

US FDA News: FDA Provides Update on Efforts to Increase Supply and Availability of Safe and Nutritious Infant Formula

FDA is providing an update on steps it has taken and will take to ensure safe and nutritious infant formula
Read more: FDA Provides Update on Efforts to Increase Supply and Availability of Safe and Nutritious Infant Formula

US FDA News: FDA Announces Plans for Proposed Rule to Reduce Addictiveness of Cigarettes and Other Combusted Tobacco Products

The Biden-Harris Administration published plans for future potential regulatory actions that include the FDA’s plans to develop a proposed product standard that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products.
Read more: FDA Announces Plans for Proposed Rule to Reduce Addictiveness of Cigarettes and Other Combusted Tobacco Products

US FDA News: Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

The FDA is informing patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy that must be considered.
Read more: Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

US FDA News: FDA Alerts Providers and Patients to Check for Premature Battery Depletion in Certain Medtronic Pacemakers: FDA Safety Communication (UNPUBLISHED)

The FDA is issuing this safety communication to alert health care providers and patients about issues that may cause batteries in certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) to drain more quickly than expected.
Read more: FDA Alerts Providers and Patients to Check for Premature Battery Depletion in Certain Medtronic Pacemakers: FDA Safety Communication (UNPUBLISHED)

US FDA News: Draeger, Inc Recalls SafeStar 55 Breathing System Filters for Possible Obstructions That May Block Oxygen Flow To Patients

SafeStar 55 Breathing System Filters reduce contaminants to ventilated patients. A defective lot may have obstructions that keep patients from getting oxygen.
Read more: Draeger, Inc Recalls SafeStar 55 Breathing System Filters for Possible Obstructions That May Block Oxygen Flow To Patients

US FDA News: FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States: FDA Safety Communication (UNPUBLISHED)

The FDA is warning of risks associated with the use of devices for diabetes management unauthorized for sale in the U.S., whether used alone or along with other devices.
Read more: FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States: FDA Safety Communication (UNPUBLISHED)

US FDA News: UPDATE on Type III Endoleaks Associated with Endovascular Graft Systems – Letter to Health Care Providers

UPDATE on Type III Endoleaks Associated with Endovascular Graft Systems
Read more: UPDATE on Type III Endoleaks Associated with Endovascular Graft Systems – Letter to Health Care Providers

US FDA News: Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication
Read more: Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

US FDA News: FDA Infant Formula Update: June 17, 2022

FDA exercises enforcement discretion to Danone to import Aptamil infant formula products from Ireland following review of nutritional adequacy and safety information, including microbiological testing, labeling, facility production and inspection history.
Read more: FDA Infant Formula Update: June 17, 2022

US FDA News: FDA Roundup: June 17, 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: June 17, 2022

US FDA News: Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age

The FDA authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.
Read more: Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age

US FDA News: FDA Infant Formula Update: June 15, 2022

FDA exercises enforcement discretion to Mead Johnson Nutrition/Reckitt to import Enfamil Stage 1 infant formula products from Singapore following review of nutritional adequacy and safety information, including microbiological testing, labeling, facility production and inspection history.
Read more: FDA Infant Formula Update: June 15, 2022

US FDA News: Latin Foods Market Issues Voluntary Nationwide Recall of Artri King Reforzado Con Ortiga Y Omega 3 Due to the Presence of Undeclared Diclofenac and Dexamethasone

Latin Foods Market is voluntarily recalling one lot, LOTE 334 21, of Artri King Reforzado con Ortiga y Omega 3 tablets to the consumer level.
Read more: Latin Foods Market Issues Voluntary Nationwide Recall of Artri King Reforzado Con Ortiga Y Omega 3 Due to the Presence of Undeclared Diclofenac and Dexamethasone

US FDA News: FDA Roundup: June 14, 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: June 14, 2022

US FDA News: UPDATE: Potential Risk of Infection When Using Heater-Cooler Devices – Letter to Health Care Providers

The FDA provides updated information from our ongoing evaluation of NTM infections in patients who have had cardiothoracic surgery using heater-cooler devices.
Read more: UPDATE: Potential Risk of Infection When Using Heater-Cooler Devices – Letter to Health Care Providers

US FDA News: FDA Approves First Systemic Treatment for Alopecia Areata

The FDA approved a treatment for adults with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each year.
Read more: FDA Approves First Systemic Treatment for Alopecia Areata

US FDA News: FDA Roundup: June 10, 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: June 10, 2022

US FDA News: FDA Infant Formula Update: June 10, 2022

FDA exercises enforcement discretion to Abbott to import various Similac infant formula products from Spain following review of nutritional adequacy and safety information, including microbiological testing, labeling, facility production and inspection history.
Read more: FDA Infant Formula Update: June 10, 2022

US FDA News: Green Pharmaceuticals Inc Issues Voluntary Nationwide Recall of SnoreStop NasoSpray Due to Microbial Contamination

Camarillo, California, Green Pharmaceuticals Inc is voluntarily recalling lot 2373/21222 of SnoreStop NasoSpray, packaged in 0.3 FL OZ (9ml) bottles to the consumer level. FDA testing found product to contain microbial contamination identified as Providencia rettgeri. This microorganism is rarely as
Read more: Green Pharmaceuticals Inc Issues Voluntary Nationwide Recall of SnoreStop NasoSpray Due to Microbial Contamination

US FDA News: FDA Infant Formula Update: June 9, 2022

FDA exercises enforcement discretion to Nestlé to import NAN Expert Pro Sensi Pro infant formula from Germany following review of nutritional adequacy and safety information, including microbiological testing, labeling, facility production and inspection history.
Read more: FDA Infant Formula Update: June 9, 2022

US FDA News: Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination

Lawrence, Kansas – Plastikon Healthcare, LLC is voluntarily recalling one (1) lot of Milk of Magnesia 2400 mg/10 mL Oral Suspension, one (1) lot of Milk of Magnesia 2400 mg/30 mL Oral Suspension, eleven (11) lots of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL
Read more: Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination

US FDA News: FDA Launches Campaign Aimed at Preventing E-Cigarette Use Among American Indian/Alaska Native Youth

The FDA launches youth e-cigarette prevention campaign, "Next Legends," to educate American Indian/Alaska Native (AI/AN) youth about the harms of vaping.
Read more: FDA Launches Campaign Aimed at Preventing E-Cigarette Use Among American Indian/Alaska Native Youth

US FDA News: Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect

Medtronic recalls pump implant kit due to a pump weld defect that may lead to corrosion of pump internal parts and cause the pump to rotate incorrectly.
Read more: Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect

US FDA News: FDA Roundup: June 7, 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: June 7, 2022

US FDA News: Buzzagogo, Inc. Issues Voluntary Nationwide Recall of Allergy Bee Gone for Kids Nasal Swab Remedy Due to Potential Microbial Contamination

Nottingham, NH, Buzzagogo Inc. is voluntarily recalling one lot of Allergy Bee Gone for Kids Nasal Swab Remedy to the consumer level due to potential microbial contamination. FDA testing found some product to contain elevated levels of yeast & mold and may contain the bacteria Bacillus cereus.
Read more: Buzzagogo, Inc. Issues Voluntary Nationwide Recall of Allergy Bee Gone for Kids Nasal Swab Remedy Due to Potential Microbial Contamination

US FDA News: FDA Roundup: June 3, 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: June 3, 2022

US FDA News: Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms

All Philips Respironics V60 and V60 Plus Ventilators are recalled due to a power issue that may cause ventilator to stop with or without an alarm.


Read more: Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms

US FDA News: FDA Infant Formula Update: June 3, 2022

FDA exercises enforcement discretion to Nestlé to import Gerber Good Start Gentle infant formula from Mexico following review of nutritional adequacy and safety information, including microbiological testing, labeling, facility production and inspection history.
Read more: FDA Infant Formula Update: June 3, 2022

US FDA News: FDA Launches New Dietary Supplement Education Initiative for Consumers, Educators, and Healthcare Professionals

Today, FDA launched its “Supplement Your Knowledge” initiative, with materials for consumers, educators, and healthcare professionals to help educate, inform, and broaden their understanding of dietary supplements.
Read more: FDA Launches New Dietary Supplement Education Initiative for Consumers, Educators, and Healthcare Professionals

US FDA News: Atrium Medical Corporation Recalls iCast Covered Stent for Potential Balloon or Catheter Hub Separation That May Cause Patient Harm

The iCast catheter-placed stent supports the walls of structure within the body. The balloon or catheter hub may separate during removal, causing harm to the patient.
Read more: Atrium Medical Corporation Recalls iCast Covered Stent for Potential Balloon or Catheter Hub Separation That May Cause Patient Harm

US FDA News: FDA Infant Formula Update: June 2, 2022

FDA Infant Formula Update: June 2, 2022
Read more: FDA Infant Formula Update: June 2, 2022

US FDA News: FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication

Renuvion/J-Plasma has not been cleared for Aesthetic Skin Procedures. FDA warns patients & health care providers of potential risks.
Read more: FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication

US FDA News: Ukoniq (umbralisib): Drug Safety Communication - FDA Approval of Lymphoma Medicine is Withdrawn Due to Safety Concerns

Due to safety concerns, the FDA has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving Ukoniq.
Read more: Ukoniq (umbralisib): Drug Safety Communication - FDA Approval of Lymphoma Medicine is Withdrawn Due to Safety Concerns

US FDA News: Walmart Inc. Issues Voluntary Nationwide Recall of Various Artri Ajo King Joint Supplements Due to Potential Hidden Drug Ingredients

Walmart Inc. is voluntarily recalling all lots of Artri Ajo King Joint Supplements sold by Innovacion Naturals and PDX Supply Warehouse LLC on Walmart.com and shipped by Walmart to the consumer level. FDA laboratory analysis confirmed that Artri Ajo King Omega 3 Joint Support Supplement with LOTE LT
Read more: Walmart Inc. Issues Voluntary Nationwide Recall of Various Artri Ajo King Joint Supplements Due to Potential Hidden Drug Ingredients

US FDA News: FDA Roundup: May 31, 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: May 31, 2022

US FDA News: FDA Roundup: May 27, 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: May 27, 2022

US FDA News: FDA Efforts to Result in Millions of Additional Bottles of Infant Formula to Further Increase U.S. Supply

The FDA is providing an update on additional steps it has taken that will lead to more infant formula on U.S. store shelves in the coming weeks and months.
Read more: FDA Efforts to Result in Millions of Additional Bottles of Infant Formula to Further Increase U.S. Supply

US FDA News: ArjoHuntleigh Polska Recalls Sara Plus Floor Lift for Risk of Smoke or Fire When Lift Is Used with Depleted Battery

The Arjo Sara Plus is an active floor lift. When it is used with a depleted battery, the device may smoke or catch on fire.
Read more: ArjoHuntleigh Polska Recalls Sara Plus Floor Lift for Risk of Smoke or Fire When Lift Is Used with Depleted Battery

US FDA News: FDA Flexibilities, Collaboration to Yield Millions of Bottles of Specialized Medical Infant Formula in Coming Months to Increase U.S. Supply

The FDA is providing an update on steps it has taken that will lead to millions of bottles of specialized medical infant formula to help address immediate needs for infants with certain allergies or critical health conditions.
Read more: FDA Flexibilities, Collaboration to Yield Millions of Bottles of Specialized Medical Infant Formula in Coming Months to Increase U.S. Supply

US FDA News: Abbott Medical Recalls Dragonfly OpStar Imaging Catheter for Potential Loose Catheter Marker Band That May Cause Patient Harm

The Dragonfly OpStar imaging catheter is used to image coronary arteries. A marker band on it may become loose during use, which may cause harm to the patient.
Read more: Abbott Medical Recalls Dragonfly OpStar Imaging Catheter for Potential Loose Catheter Marker Band That May Cause Patient Harm

US FDA News: Urgent Voluntary Recall: CorneaGen Cornea/ Cornea Patch Grafts; CorneaGen is voluntarily recalling Corneal Patch Grafts bearing the following product numbers: W419221004861104; W419221004861105; W419221004861106; W419221004861103

On January 5, 2022, CorneaGen discovered that Cornea Patch Grafts were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody and were shipped prior to being medically cleared.
Read more: Urgent Voluntary Recall: CorneaGen Cornea/ Cornea Patch Grafts; CorneaGen is voluntarily recalling Corneal Patch Grafts bearing the following product numbers: W419221004861104; W419221004861105; W419221004861106; W419221004861103

US FDA News: FDA Flexibilities to Yield Millions of Cans of Additional Infant Formula in Coming Months to Increase Supply Available to U.S. Consumers

FDA is providing an update on steps it has taken that will lead to millions of cans of additional infant and specialty formula being available to U.S. consumers.
Read more: FDA Flexibilities to Yield Millions of Cans of Additional Infant Formula in Coming Months to Increase Supply Available to U.S. Consumers

US FDA News: FDA Roundup: May 24, 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: May 24, 2022

US FDA News: FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder

The FDA approved the first treatment for eosinophilic esophagitis, a chronic immune disorder, in adults and pediatric patients (12 years and older weighing at least 40 kilograms, which is about 88 pounds).
Read more: FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder

US FDA News: FDA Roundup: May 20, 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: May 20, 2022

US FDA News: Urgent Voluntary Recall: CorneaGen Sclera / Scleral Patch Grafts; CorneaGen is voluntarily recalling the entire lot of Scleral Patch Grafts obtained from (Lot Number) W419221008338

CorneaGen is voluntarily recalling the entire lot of Scleral Patch Grafts obtained from (Lot Number) W419221008338
Read more: Urgent Voluntary Recall: CorneaGen Sclera / Scleral Patch Grafts; CorneaGen is voluntarily recalling the entire lot of Scleral Patch Grafts obtained from (Lot Number) W419221008338

US FDA News: 2022 Biologics Recalls

Listing of the 2022 Biologics Recalls
Read more: 2022 Biologics Recalls

US FDA News: Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

This update provides additional information on the recall and recommendations for people who use repaired and replaced devices.
Read more: Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

US FDA News: FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain

FDA is issuing a draft guidance, Risk Management Plans to Mitigate the Potential for Drug Shortages, intended to help with the development, maintenance and implementation of risk management plans.
Read more: FDA Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain

US FDA News: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls

Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall
Read more: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls

US FDA News: New FDA Draft Guidance Aims to Increase Safety Information About Dietary Supplement Marketplace

The FDA announced the availability of a draft guidance aimed at increasing the amount of safety information the agency has about the dietary supplement marketplace by providing the industry an opportunity to submit late new dietary ingredient (NDI) notifications.
Read more: New FDA Draft Guidance Aims to Increase Safety Information About Dietary Supplement Marketplace

US FDA News: FDA Roundup: May 17, 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: May 17, 2022

US FDA News: Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years

The FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine
Read more: Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years

US FDA News: FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability

FDA announced guidance outlining increased flexibilities on importation of certain infant formula products to further increase the availability across the country while protecting the health of infants.
Read more: FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability

US FDA News: FDA Provides New Updates on Activities to Mitigate Infant Formula Supply Challenges, Abbott Nutrition Agrees to Take Corrective Actions at Facility to Produce Safe Infant Formula

Under the proposed consent decree, Abbott has agreed to take corrective actions following an FDA inspection of its Sturgis, Michigan, facility.
Read more: FDA Provides New Updates on Activities to Mitigate Infant Formula Supply Challenges, Abbott Nutrition Agrees to Take Corrective Actions at Facility to Produce Safe Infant Formula

US FDA News: Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV

Today, FDA authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test, the first direct-to-consumer (non-prescription) multi-analyte COVID-19 test authorized by FDA.
Read more: Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV

US FDA News: Woodside Acquisitions Inc. Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) That Are Not Authorized, Cleared, or Approved by the FDA

Woodside Acquisitions Inc. recalls COVID-19 Rapid Test Kits because they are not authorized, cleared, or approved by the FDA.
Read more: Woodside Acquisitions Inc. Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) That Are Not Authorized, Cleared, or Approved by the FDA

US FDA News: FDA Roundup: May 13, 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: May 13, 2022

US FDA News: Avanos Medical Recalls Cortrak*2 Enteral Access System for Risk of Misplaced Enteral Tubes Could Cause Patient Harm

Avanos Medical CORTRAK*2 Enteral Access System is being recalled because misplaced enteral tubes may cause patient harm.
Read more: Avanos Medical Recalls Cortrak*2 Enteral Access System for Risk of Misplaced Enteral Tubes Could Cause Patient Harm

US FDA News: FDA Approves Novel, Dual-Targeted Treatment for Type 2 Diabetes

The FDA approved a new treatment to improve blood sugar control in adults with type 2 diabetes, as an addition to diet and exercise.
Read more: FDA Approves Novel, Dual-Targeted Treatment for Type 2 Diabetes

US FDA News: FDA Roundup: May 10, 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: May 10, 2022

US FDA News: FDA Takes Important Steps to Improve Supply of Infant and Specialty Formula Products

The FDA is providing an update on its work to increase the availability of infant and specialty formula products.
Read more: FDA Takes Important Steps to Improve Supply of Infant and Specialty Formula Products

US FDA News: SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA

SML Distribution Recalls Unauthorized COVID-19 Direct Antigen Rapid Tests because they are not authorized, cleared, or approved by the FDA.
Read more: SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA

US FDA News: Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety Communication

The FDA is warning people not to use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests. The test’s performance has not been adequately established.
Read more: Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety Communication

US FDA News: Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2 Tests for Risk of False Positives Caused by Contamination

Mesa BioTech’s Accula SARS-CoV-2 Tests are being recalled because facility contamination may cause them to give false positive results.
Read more: Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2 Tests for Risk of False Positives Caused by Contamination

US FDA News: FDA Roundup: May 6, 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: May 6, 2022

US FDA News: Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers

The FDA is evaluating the potential risk of exposure to toxic compounds when using certain Fresenius Medical Care hemodialysis machines
Read more: Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers

US FDA News: Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

The FDA has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 older for whom other available COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 and older who elect to receive it because they would otherwise not receive a COVID-19 vaccine.
Read more: Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

US FDA News: FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease

FDA today permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease.
Read more: FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease

US FDA News: FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products

The FDA issued warning letters to five companies for selling products labeled as containing delta-8 THC in ways that violate the FD&C Act. This action is the first time the FDA has issued warning letters for products containing delta-8 THC.
Read more: FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products

US FDA News: FDA Roundup: May 3, 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: May 3, 2022

US FDA News: Philips Respironics Issues Voluntary Recall Notification/Field Safety Notice* for the V60 Ventilator Product Family

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that its subsidiary Philips Respironics is notifying customers of its V60/V60 Plus and V680 ventilators about a potential issue with the electrical circuit in these ventilators that controls the 35V power sup
Read more: Philips Respironics Issues Voluntary Recall Notification/Field Safety Notice* for the V60 Ventilator Product Family

US FDA News: Fagron Inc. Issues Voluntary Nationwide Recall of SyrSpend SF Cherry Due to Microbial Contamination

St. Paul, Minnesota, Fagron Inc. (“Fagron”) is voluntarily recalling two lots of SyrSpend SF Cherry to the hospital, pharmacy, and distributor level out of an abundance of caution. The affected lots are potentially contaminated with Burkholderia gladioli. Burkholderia gladioli is an opportunistic pa
Read more: Fagron Inc. Issues Voluntary Nationwide Recall of SyrSpend SF Cherry Due to Microbial Contamination

US FDA News: FDA Roundup: April 29, 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: April 29, 2022

US FDA News: Coronavirus (COVID-19) Update: FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines

The FDA plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of potential submissions of emergency use authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.
Read more: Coronavirus (COVID-19) Update: FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines

US FDA News: La FDA propone normas que prohíben los cigarrillos mentolados y puros saborizados para prevenir la iniciación al tabaquismo en adolescentes y reducir significativamente la morbilidad y mortalidad relacionadas con el uso del tabaco

La FDA ha propuesto normas para productos de tabaco que prohíben el mentol en los cigarrillos y todos los sabores en los puros.
Read more: La FDA propone normas que prohíben los cigarrillos mentolados y puros saborizados para prevenir la iniciación al tabaquismo en adolescentes y reducir significativamente la morbilidad y mortalidad relacionadas con el uso del tabaco

US FDA News: Stop New Implants of the Medtronic HVAD System – Letter to Health Care Providers

Medtronic has stopped the sale and distribution of HVAD because the internal pump may delay or fail to restart.
Read more: Stop New Implants of the Medtronic HVAD System – Letter to Health Care Providers

US FDA News: Potential for Internal Pump Malfunction in the Medtronic HVAD System – Letter to Health Care Providers

The FDA is issuing this letter to ensure you are aware of this defect and the recommended actions to take to manage the care of patients currently implanted with a Medtronic HVAD system.
Read more: Potential for Internal Pump Malfunction in the Medtronic HVAD System – Letter to Health Care Providers

US FDA News: Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized, Non-CLIA-Certified Users

COVID-19 Ag Rapid Tests are being recalled because they may have been distributed to unauthorized, non-CLIA-certified users.
Read more: Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized, Non-CLIA-Certified Users

US FDA News: FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars to Prevent Youth Initiation, Significantly Reduce Tobacco-Related Disease and Death

FDA proposed product standards to prohibit menthol in cigarettes and all flavors in cigars.
Read more: FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars to Prevent Youth Initiation, Significantly Reduce Tobacco-Related Disease and Death