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