Abbott Initiates Voluntary Recall of Specific Lots of Two Coronary Catheters

Summary Company Announcement Date: February 20, 2020 FDA Publish Date: February 20, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Catheter balloon may not deflate as intended Company Name: Abbott Brand Name: Brand Name(s) Product Description: Product Description Coronary dilatation catheters Company Announcement Abbott has voluntarily recalled specific lots of two catheters…

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5ml 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…

Abbott Vascular Recalls NC Trek RX and NC Traveler RX Coronary Dilatation Catheters Due to Failure of Balloon (diameter 4.0mm, 4.5mm and 5.00mm) to Deflate

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: NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation CathetersModels: Balloon diameters 4.0mm, 4.5mm and 5.0mmLots: See a full list of affected devices Distribution…

Fighting Diabetes’ Deadly Impact on Minorities

Español You inherit more than your eye and hair color from your family. You can also inherit a predisposition for diabetes, a disease that disproportionally affects racial and ethnic minorities. The Office of Minority Health (OMH) at the Food and Drug Administration (FDA) is building relationships with the American Diabetes Association (ADA) and other groups…

FDA Ensures Your Foods From Animals Are Safe

Español If you eat meat or drink milk, you want to know: Are there trace amounts of the veterinary drugs used in food-producing animals entering your diet? And if they are, are the amounts safe for human consumption? Those questions—among others—are the concern of the Division of Residue Chemistry, which is part of FDA’s Center…

Benzocaine and Babies: Not a Good Mix

Español  Subscribe: FDA Consumer Health Information When a baby is teething, many a mom or dad reaches for a pain remedy containing benzocaine to help soothe sore gums.  Benzocaine is a local anesthetic and can be found in such over-the-counter (OTC) products as Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase. But the use of benzocaine…

Caution: Some Over-the-Counter Medicines May Affect Your Driving

Español Anyone who operates a vehicle of any type—car, bus, train, plane, or boat—needs to know there are over-the-counter medicines that can make you drowsy and can affect your ability to drive and operate machinery safely. Over-the-counter medicines are also known as OTC or nonprescription medicines. All these terms mean the same thing: medicines that…

Fact or Fiction: What to Know About Smoking Cessation and Medications

[embedded content] Spanish Tobacco use is the leading preventable cause of death in the United States, resulting in more than 480,000 deaths annually. Almost 70 percent of current smokers report wanting to quit smoking, but quitting can be hard and often takes multiple attempts. A variety of FDA-approved medications are available to help people successfully…