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…

Manage Your Asthma: Know Your Triggers and Treatment Options

Español Asthma is a chronic lung disease that causes the airways to become inflamed and narrow. Symptoms of an asthma attack can include coughing, wheezing (a whistling sound when you breathe), chest tightness, and shortness of breath. There are many other conditions that can have the same symptoms, so it is important to check with…

Medication Errors Happen to Pets Too

Your dog or cat is sick, and you head to the animal hospital. The veterinarian prescribes medications that you hope will make your friend better. But with pets, as with people, medication errors can happen. Pet owners may mistakenly be given the wrong medicine for any number of reasons. Just as it does when medication…

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension Usp, 125 Mg/5 Ml due to Possible Underdosing or Overdosing

Summary Company Announcement Date: February 20, 2020 FDA Publish Date: February 21, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Possible underdosing or overdosing Company Name: Taro Pharmaceuticals U.S.A., Inc. Brand Name: Brand Name(s) Taro Pharmaceuticals U.S.A., Inc. Product Description: Product Description Phenytoin Oral Suspension USP, 125 mg/5 mL Company Announcement Taro Pharmaceuticals…

Nipple Aspirate Test Is No Substitute for Mammogram

Español A mammogram is a low-dose X-ray picture of the breast—and it’s still the best way for health care providers to screen women for breast cancer. (Breast cancer screening lets health care providers check for cancer before there are signs and symptoms of the disease.) Unfortunately, in the past, other tests have been falsely described…