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.
FDA approves Empliciti, a new immune-stimulating therapy to treat multiple myeloma
Today the U.S. Food and Drug Administration granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications.
FDA Announces Glades Drugs’ Nationwide Voluntary Recall Of Compounded Multivitamins Containing High Amounts Of Vitamin D3 (Cholecalciferol)
The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of compounded multivitamin capsules containing high amounts of Vitamin D3 (Cholecalciferol), distributed nationwide by Glades Drugs in Pahokee, Florida. FDA has received reports of several adverse events potentially associated with these compounded capsules made by Glades Drugs.
Taylor Farms Pacific, Inc. Recalls Celery Products Because Of Possible Health Risk
Taylor Farms Pacific, Inc. of Tracy, CA, is recalling the products listed below because they may include celery which could potentially contain E. coli 0157:H7. The products listed below are being recalled out of an abundance of caution due to a Celery and Onion Diced Blend testing positive for E. coli 0157:H7 in a sample taken by the Montana Department of Health.
Bertagni 1882 Spa Issues Allergy Alert On Undeclared Almond And Cashew In Butternut Squash Ravioli
Bertagni 1882 SPA of Arcugnano, Italy is recalling Bertagni fresh Sweet Butternut Squash Ravioli and Meijer frozen Butternut Squash Ravioli because the products may contain undeclared cashew and almond. People who have an allergy or severe sensitivity to cashew or almond run the risk of serious or life-threatening allergic reaction if they consume these products.