The U.S. Food and Drug Administration today announced the winners of the 2014 FDA Food Safety Challenge, a prize competition to advance breakthrough ideas on how to find disease-causing organisms in food – especially Salmonella in fresh produce. The grand prize winner and runner-up winner will receive $300,000 and $100,000 in prize money, respectively.
The U.S. Food and Drug Administration today authorized use of the first prosthesis marketed in the U.S. for adults who have amputations above the knee and who have rehabilitation problems with, or cannot use, a conventional socket prosthesis.
D&D Foods, Inc., based in Omaha, Nebraska, is recalling 3-pound containers of Hy-Vee American Macaroni Salad because they were incorrectly labeled and may contain undeclared milk and wheat (gluten). People who have an allergy or severe sensitivity to milk and wheat (gluten) run the risk of serious or life-threatening allergic reaction if they consume these […]
The U.S. Food and Drug Administration today approved Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.
On July 10, the U.S. Food and Drug Administration approved Rexulti (brexpiprazole) tablets to treat adults with schizophrenia and as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD).
Maya Overseas Foods Inc. of Maspeth, NY, is recalling approximately 8000 lbs. of Cashew Split 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 […]
On July 10, 2015, the United States District Court for the District of Nevada entered a consent decree of permanent injunction against Bio Health Solutions LLC, of Las Vegas and its manager and co-owner, Mark Garrison, for selling RenAvast, an unapproved animal drug.
Carnivore Meat Company, LLC is recalling select products and lots of Carnivore Vital Essentials pet foods because they have the potential to be contaminated with Listeria monocytogenes. Healthy cats and dogs rarely become sick from Listeria monocytogenes. In humans, however, Listeria is an organism which can cause serious and sometimes fatal infections in young children, […]
The U.S. Food and Drug Administration today approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure.
The U.S. Food and Drug Administration today approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure.
Boulder Dog Food Company, L.L.C. is voluntarily recalling the Turkey Sprinkles (3 oz.) with a “Best By” date of “05/18/16, 05/28/2016 and 05/30/2016”, a Lot Number of “743”, and a UPC Code of 899883001224 because the product has the potential of being contaminated with Salmonella. Salmonella can affect animals eating the product, and there is […]
The U.S. Food and Drug Administration today approved the first drug for cystic fibrosis directed at treating the cause of the disease in people who have two copies of a specific mutation.
Vitamin Cottage Natural Food Markets Inc., a Lakewood, Colo., based natural grocery chain, is recalling one lot of Natural Grocers brand Caribbean Nut & Fruit Mix as the product contains macadamia nuts that have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail […]
A federal judge for the District of New Jersey has entered a consent decree of permanent injunction between the United States and Acino Products LLC (Acino), of Hamilton, New Jersey, and the company’s president, Ravi Deshpande, for marketing unapproved and misbranded prescription drugs.
The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation.
H-E-B, committed to the quality of its products, is issuing a voluntary recall for H-E-B brand hamburger and hotdog buns and Hill Country Fare hotdog buns due to the possible presence of foreign material that might impact the quality of the product. A terry cloth glove used for handling hot pans could have broken up […]
Today, the U.S. District Court of the District of New Jersey sentenced the OtisMed Corporation’s (OtisMed) former chief executive officer, Charlie Chi, to 24 months in prison and also ordered him to serve one year of supervised release and to pay a $75,000 fine.
The U.S. Food and Drug Administration today approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. It is approved for adult patients undergoing percutaneous coronary intervention (PCI), a procedure used to open a blocked or narrowed coronary […]
United Salad Co., the distributor of Portland, Oregon, is initiating a voluntary recall of Champ’s Sliced Crimini Mushrooms, product of Canada, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. […]