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…
Saratoga Potato Chips, LLC Issues Allergy Alert on Undeclared Milk in Kroger Sweet & Mesquite BBQ Potato Chips
Summary Company Announcement Date: February 19, 2020 FDA Publish Date: February 19, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Saratoga Potato Chips, LLC Brand Name: Brand Name(s) Product Description: Product Description Sweet & Mesquite BBQ Potato Chips Company Announcement Saratoga Potato Chips, llc of Fort Wayne,…
Teleflex Medical Recalls Comfort Flo Humidification Systems Due to Malfunction That May Cause Water to Enter Airway
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 Name and Version: COMFORT FLO Humidification System, REF 2410, Humidifier Nebulizer Kit Product Code: GTIN 14026704659347 Name and Version: COMFORT FLO Humidification System with Remote Temperature Port,…
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…
CJ Foods Voluntarily Recalls Annie Chun’s Japanese-Style Teriyaki Noodle Bowls Due To Undeclared Peanuts
Summary Company Announcement Date: February 14, 2020 FDA Publish Date: February 15, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared peanuts Company Name: CJ Foods, Inc. Brand Name: Brand Name(s) Annie Chun’s Product Description: Product Description Japanese-Style Teriyaki Noodle Bowls Company Announcement CJ Foods, Inc., a division of CJ America,…