[Posted 03/04/2020] AUDIENCE: Patient, Health Professional, Pharmacy, Allergy and Immunology ISSUE: FDA is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics), which is a prescription medicine for asthma and allergy. FDA is taking this action after a review of available information that led us to reevaluate the benefits and risks…
Nutrition Facts Label Better Informs Your Food Choices
Español A lot has changed in the American diet since the Nutrition Facts label was introduced in 1993 to provide important nutrition information on food packages. The U.S. Food and Drug Administration (FDA) has brought this familiar rectangular box—one of the most recognized graphics in the world—up to date with changes to its design and…
Allergy Alert Issued for Undeclared Milk in Green Chile Chicken Tamales Sold at Whole Foods Market Stores in Multiple States
Summary Company Announcement Date: March 03, 2020 FDA Publish Date: March 03, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Milk Company Name: Whole Foods Market Brand Name: Brand Name(s) Whole Foods Market Product Description: Product Description Green Chile Chicken Tamales Company Announcement Whole Foods Market is voluntarily recalling select…
New Capstone, Inc. Issues Allergy Alert on Restructure Vanilla Protein Powder Due to Undeclared Milk
Summary Company Announcement Date: March 03, 2020 FDA Publish Date: March 03, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Milk Company Name: New Capstone, Inc. Brand Name: Brand Name(s) ReStructure Product Description: Product Description Vanilla Protein Powder Company Announcement New Capstone, Inc. of Mooresville, NC is recalling their 22oz…
SweynTooth Cybersecurity Vulnerabilities May Affect Certain Medical Devices: FDA Safety Communication
The U.S. Food and Drug Administration (FDA) is informing patients, health care providers, and manufacturers about the SweynTooth family of cybersecurity vulnerabilities, which may introduce risks for certain medical devices. The FDA is not aware of any confirmed adverse events related to these vulnerabilities. Software to exploit these vulnerabilities in certain situations is already publicly…
Continuous Positive Airway Pressure (CPAP) Machine Cleaning
[embedded content] Español If you use a CPAP machine at night to help you breathe during sleep, you know it can be difficult to keep up a regular cleaning schedule. A dirty CPAP machine contaminated with germs like viruses and bacteria can make you sick. So automated machines advertised on TV that claim to clean…
Report Kids’ Problems With Medical Products
Español Consumers can play a critical role in helping the Food and Drug Administration (FDA) assure children’s access to safe medical products. Reporting to FDA such “adverse events” as unexpected, serious side effects, accidental exposure, and product quality issues can prompt the agency to act—and it can also bring new pediatric safety information to light….
Safely Soothing Teething Pain and Sensory Needs in Babies and Older Children
Consider treating teething pain with a teething ring made of firm rubber (not frozen) or by rubbing the gums with a clean finger. Español Teething is normal but may be a painful experience for infants and toddlers. Too often, well-meaning parents and caregivers who want to ease a child’s pain turn to medications and products…
UPDATE: The FDA recommends performing contained morcellation in women when laparoscopic power morcellation is appropriate
Date issued: February 25, 2020 The U.S. Food and Drug Administration (FDA) is updating our 2014 safety communication on laparoscopic power morcellators to provide new information on the safe and effective use of laparoscopic power morcellation for gynecologic procedures. The FDA recommends performing laparoscopic power morcellation for myomectomy or hysterectomy only with a tissue containment…
Safe Use of Flea and Tick Products in Pets
Español Flea bites may be more than an itchy annoyance to some dogs and cats. They can cause flea allergy dermatitis—an allergic reaction to proteins in flea saliva. And a pet’s constant scratching can cause permanent hair loss or other skin problems. Fleas feasting on your pet’s blood can lead to anemia and, in rare…