Today, the U.S. Food and Drug Administration cleared for marketing in the United States the first cooling cap to reduce hair loss (alopecia) in female breast cancer patients undergoing chemotherapy.
FDA approves first recombinant von Willebrand factor to treat bleeding episodes
The U.S. Food and Drug Administration today approved Vonvendi, von Willebrand factor (Recombinant), for use in adults 18 years of age and older who have von Willebrand disease (VWD). Vonvendi is the first FDA-approved recombinant von Willebrand factor, and is approved for the on-demand (as needed) treatment and control of bleeding episodes in adults diagnosed with VWD.
FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients
Today, the U.S. Food and Drug Administration approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency.
Kroger Recalls Bakery Fresh Goodness Chocolate Brownies Due to Undeclared Allergens
The Kroger Co. (NYSE: KR) said today it has recalled Bakery Fresh Goodness chocolate brownies (16 oz, tub) sold in its retail stores because the product may contain walnuts not listed on the label. People who are allergic to walnuts could have a severe reaction if they consume this product.
FDA clears military traumatic wound dressing for use in the civilian population
Today, the U.S. Food and Drug Administration cleared the use of the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed (such as the groin or armpit) in battlefield and civilian trauma settings. The clearance expands the device’s indication for use from use by the military only to use in adults and adolescents in the general population.
Lipo Escultura Corp. Issues Nationwide Recall of Lipo Escultura Due to Undeclared Sibutramine and Diclofenac
Lipo Escultura Corp. of Brooklyn, NY dba JAT Productos Naturales Corp., and JAT Natural Products Corp. are voluntarily recalling all Lipo Escultura within expiry to the consumer level. The Lipo Escultura capsules were tested by the U.S. Food and Drug Administration and have been found to contain two potentially harmful ingredients–sibutramine and diclofenac.
JEM Raw Chocolate LLC Voluntarily Recalls Nut Butter Spread Products Due To Possible Health Risk
JEM Raw Chocolate, LLC (JEM Raw) of Bend, Oregon announced a voluntary recall of its full line of all nut butter spreads within expiry because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
Insulet Corporation Issues Field Safety Notification of OmniPod Insulin Management System
On November 2, 2015, Insulet Corporation (Insulet or the Company) initiated a lot-specific voluntary Field Safety Notification (Notification) for 15 lots of the OmniPod (Pod) which were distributed in the U.S. and three lots which were distributed internationally.
Bestmed, LLC Issues Nationwide Recall Of Digital Temple Thermometer (DTT™), Model No. KD-2201 Manufactured By K-Jump Health Co., Ltd.
On November 12, 2015, Bestmed, LLC, a medical device distributor, initiated a nationwide recall of the Digital Temple Thermometer Model No. KD-2201 manufactured by K-Jump Health Co., Ltd, featuring lot numbers S/N: 3612 through S/N: 3715, which were sold between October 2012 until the start of the recall in November 2015.
Bertagni 1882 Spa Issues Allergy Alert on Undeclared Cashew and Almond in Sweet Butternut Squash Ravioli
The product is packaged as Simply Roundy’s Natural – Authentic Italian Sweet Butternut Squash Ravioli, UPC011150507509 in Mariano’s Stores in Illinois and Copps, Pick ‘n Save and Metro Market in Wisconsin
Bertagni 1882 SpA of Arcugnano, Italy is recalling Bertagni Sweet Butternut Squash Ravioli (UPC#8001020110139) because the product may contain undeclared cashews and almonds.