Español Depression is a serious medical illness. Also called “major depressive disorder,” or “unipolar depression,” it affects about 350 million people worldwide and is a leading cause of disability, according to the World Health Organization. If you have depression, you may not recognize the symptoms or may think symptoms are due to a lack of…
Sandoz, Inc. Issues Nationwide Recall of One Lot of Enoxaparin Sodium Injection, USP 40mg/0.4 mL Due to Temperature Excursion During Shipping
Summary Company Announcement Date: December 01, 2021 FDA Publish Date: December 02, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Exposure to high temperatures may have impacted product effectiveness. Company Name: Sandoz, Inc. Brand Name: Brand Name(s) Product Description: Product Description Enoxaparin Sodium Injection Company Announcement FOR IMMEDIATE RELEASE – December 1, 2021…
Dealing with ADHD: What You Need to Know
Español Is your child in constant motion? Does he or she talk incessantly? Or have trouble focusing and prefer to daydream? Then your child may have attention deficit hyperactivity disorder (ADHD). This disorder often begins between ages 3 and 6, according to the National Institute of Mental Health (NIMH). And it’s not just a childhood…
BUBS Naturals is Recalling Two Lots of Fountain of Youth Collagen Powder After Firm Testing Found Milk Protein in The Product That Uses MCT Powder Oil as an Ingredient
Summary Company Announcement Date: December 03, 2021 FDA Publish Date: December 03, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Bubs Naturals Brand Name: Brand Name(s) BUBS Naturals Product Description: Product Description Fountain of Youth Formula Company Announcement FINAL BUBS Naturals Press Release 12/03/2021 BUBS Naturals of…
Arrow International Inc Recalls Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7Fr, Due to Risk of Separation
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7Fr Product Codes and Lot Numbers: See Recall Database Entry Devices Recalled in the United States: 3,241 Distribution Date: November…
Dose Matters: FDA’s Guidance on Children’s X-rays
Español [embedded content] Most people have had an X-ray taken at some time during their lives — perhaps checking for a possible broken bone or during a visit to the dentist. X-ray exams provide important information to physicians about how to treat their patients. However, X-rays use ionizing radiation, and these imaging exams must be…
Sanford Man Sentenced for Tampering with Pizza Dough
Department of JusticeU.S. Attorney’s OfficeDistrict of Maine FOR IMMEDIATE RELEASEThursday, December 2, 2021 PORTLAND, Maine: A Sanford man was sentenced today in federal court for tampering with a consumer product, U.S. Attorney Darcie N. McElwee announced. Chief U.S. District Judge Jon D. Levy sentenced Nicholas Mitchell, 39, to four years and nine months in prison…
Man Sentenced to a Year in Federal Prison for Selling Weight-Loss Product Containing Unapproved Additive
Department of JusticeU.S. Attorney’s OfficeNorthern District of Illinois FOR IMMEDIATE RELEASEMonday, November 22, 2021 CHICAGO — A federal judge in Chicago has sentenced a man to a year in prison for manufacturing and selling a purported weight-loss product containing the unapproved additive 2,4-Dinitrophenol, known as DNP. JONATHAN E. MCGRAW, 33, of Newberg, Oregon, obtained DNP…
Use Eye Cosmetics Safely
The Food and Drug Administration (FDA) regulates all cosmetics marketed in the United States, including mascara, eye shadows, eye liner, concealers, and eyebrow pencils. Safety experts within the Office of Cosmetics and Colors in FDA’s Center for Food Safety and Applied Nutrition (CFSAN) offer consumers the following advice: Keep everything clean. Dangerous bacteria or fungi…
August 7, 2019 UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality
December 2, 2021 Update: The FDA launched a new web page about paclitaxel-coated balloons and paclitaxel-eluting stents that are approved to treat obstructed lesions in arteries of the legs. The new web page includes: Paclitaxel-coated balloons and stents approved in the United States Current recommendations for health care providers Risks associated with paclitaxel-coated balloons…