Beware of Vaping Products with Unproven Health Claims

Image CaptionColourful overlapping silhouettes of e-cigarettes or vapers The U.S. Food and Drug Administration wants consumers to know certain “wellness” vaping products containing vitamins and/or essential oils are being illegally sold with unproven claims and could be harmful if used. Currently, no vaping products are approved by the FDA to prevent or treat any health…

Beware of Illegally Marketed Diabetes Treatments

Sound Too Good To Be True? Then it’s probably a scam. Watch out for these and similar red flags: “Lowers your blood sugar naturally!” “Inexpensive therapy to fight and eliminate type II diabetes!” “Protects your eyes, kidneys, and blood vessels from damage!” “Replaces your diabetes medicine!” “Effective treatment to relieve all symptoms of diabetes!”  “Natural…

Gilead Issues A Voluntary Nationwide Recall of Two Lots of Veklury® (Remdesivir) Due to Presence of Glass Particulates

Summary Company Announcement Date: December 03, 2021 FDA Publish Date: December 03, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of glass particulates Company Name: Gilead Sciences Inc. Brand Name: Brand Name(s) Product Description: Product Description Veklury® (remdesivir 100 mg for injection) Company Announcement Foster City, CA, Gilead Sciences Inc. (Nasdaq: GILD)…

FDA D.I.S.C.O. Burst Edition: FDA approval of Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound)) for locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor

Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On November 22, 2021, the FDA approved sirolimus protein-bound particles…

Bottled Water Everywhere: Keeping it Safe

Español Seems like almost everyone is carrying a bottle of water these days. The U.S. Food and Drug Administration (FDA) regulates bottled water products, working to ensure that they’re safe to drink. FDA protects consumers of bottled water through the Federal Food, Drug, and Cosmetic Act (FD&C Act), which makes manufacturers responsible for producing safe,…

Depression: FDA-Approved Medications May Help

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…

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…