Ventilator Supply Mitigation Strategies: Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) recognizes that the need for ventilators, ventilator accessories, and other respiratory devices may outpace the supply available to health care facilities during the Coronavirus Disease 2019 (COVID-19) outbreak. On March 22, 2020, the FDA issued an immediately in effect guidance outlining a policy intended to help increase availability…

Medical Glove Conservation Strategies: Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) recognizes the need for personal protective equipment (PPE), such as medical gloves, may outpace the supply available to health care organizations during the Coronavirus Disease 2019 (COVID-19) outbreak. This Letter to Health Care Providers refers specifically to potential shortages relating to surgeons’ gloves and patient examination gloves. The…

Natural Remedy Store Issues Voluntary Worldwide – Recall of Active Male Due to Presence of Undeclared Tadalafil

Summary Company Announcement Date: March 16, 2020 FDA Publish Date: March 16, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Undeclared Tadalafil Company Name: Natural Remedy Store Brand Name: Brand Name(s) Natural Remedies Product Description: Product Description Active Male capsules Company Announcement Natural Remedy Store is voluntarily recalling all lots of…

Voluntary Field Corrective Action of HiRes Ultra and Ultra 3D

Summary Company Announcement Date: February 20, 2020 FDA Publish Date: March 10, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Reports of hearing performance degradation Company Name: Advanced Bionics Brand Name: Brand Name(s) HiRes Ultra and Ultra 3D Product Description: Product Description Cochlear implants Company Announcement Advanced Bionics (AB), a global leader…

Fecal Microbiota for Transplantation: Safety Alert – Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms

[Posted 03/12/2020] AUDIENCE: Patient, Health Professional ISSUE: FDA is informing health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT).  The FDA is now aware of infections caused by enteropathogenic Escherichia coli (EPEC) and Shigatoxin-producing Escherichia coli (STEC) that have occurred following…

Where and How to Dispose of Unused Medicines

Español Is your medicine cabinet full of expired drugs or medications you no longer use? Your medicine is for you. What’s safe for you might be harmful for someone else. You can dispose of your expired, unwanted, or unused medicines through a drug take back program — or you can do it at home.  Drug…

The New Nutrition Facts Label: Why the Makeover?

Image Español You’re probably aware of the Nutrition Facts label on foods—it’s been around for more than 20 years. What you may not know is that the label has had a makeover—with improvements that can help you make healthy choices about the foods you and your family eat.  Including the example above, the U.S. Food and Drug…

Surgical Mask and Gown Conservation Strategies – Letter to Healthcare Providers

The U.S. Food and Drug Administration (FDA) recognizes that the need for personal protective equipment (PPE), such as surgical masks, surgical and isolation gowns, and surgical suits, may outpace the supply available to healthcare organization during the Coronavirus Disease 2019 (COVID-19) outbreak. The following conservation strategies for use by healthcare organizations and personnel are categorized…