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US FDA News: FDA Seeks to Improve Patient Communication on LASIK Benefits and Risks Through Issuance of Draft Guidance

FDA issues draft guidance to help ensure that information is available to patients and health care professionals to clearly communicate the benefits and risks of LASIK devices.
Read more: FDA Seeks to Improve Patient Communication on LASIK Benefits and Risks Through Issuance of Draft Guidance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