The FDA is tasked with taking important steps to respond to the emerging Zika virus outbreak. One of the agency’s key public health responsibilities is to help ensure the safety of the nation’s blood supply.
The U.S. Food and Drug Administration approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.
The U.S. Food and Drug Administration today approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections.
Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling a limited quantity of Hy-Vee No-Salt-Added Black Beans across its eight-state region due the potential presence of plastic and/or metal pieces within the product. The presence of small pieces of plastic and/or metal has the potential to cause a choking hazard and may cause […]
Faribault Foods, Inc. of Faribault, MN, is initiating a voluntary recall of a limited number of 15 ounce No-Salt-Added Black Beans due to the potential presence of plastic and/or metal pieces within the product. Read The Complete Story!
On July 15, 2016, the U.S. District Court for the District of Minnesota entered a consent decree of permanent injunction between the United States and Kwong Tung Foods, Inc., doing business as Canton Foods; its president and owner, Vieta “Victor” C. Wang; and its vice-president, Juney H. Wang, for significant and ongoing violations of the […]
The U.S. Food and Drug Administration today approved the first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, intermediate and far distances.
Monogram Appetizers of Plover, Wisconsin is recalling approximately 5000 cases of Poppers Brand Mozzarella Cheese Sticks, because it may contain undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products. Read The Complete Story!
Kerry Inc. of Beloit, WI is recalling two lots of Golden Dipt Jalapeno Breader that were sold to foodservice distributors because one of our suppliers recalled an ingredient used in our mix for the potential presence of E. coli O121. Kerry Inc. was notified by our supplier that two of their products, a red bell […]
CHOKLAND MORK, CHOKLAND MORK 70%, CHOKLAD LINGON & BLABAR, CHOKLAD NOT, GODIS CHOKLADKROKANT, GODIS CHOKLADRAN and CHOKLAD LJUS, are being recalled due to undeclared Milk, Hazelnuts and/or Almond. “All Best Before Dates,” Sold from April 30, 2015 to July 1, 2016. Read The Complete Story!
The U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) agonist, approved by the FDA for dry eye disease.
The U.S. Food and Drug Administration today approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro uses magnetic resonance (MR) images taken during the procedure to deliver focused ultrasound to destroy brain tissue in a tiny area thought to be responsible for causing tremors.
Hearn Kirkwood is initiating a voluntary recall of “Evie’s Cheddar Potato Salad” 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. Read The Complete Story!
The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
The U.S. Food and Drug Administration today approved the Roche cobas HPV Test as the first test for Human Papilloma Virus (HPV) that can be used with cervical cells obtained for a Pap test and collected in SurePath Preservative Fluid.
FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests
On Tuesday, July 5, 2016, the U.S. District Court for the Southern District of Alabama entered a consent decree of permanent injunction between the United States and BEK Catering LLC. The business, owned by Billy B. Stembridge, Jr. and Kyle D. Huxen, operates as Floppers Foods selling ready-to-eat seafood products and is based in Daphne, […]
The U.S. Food and Drug Administration today approved the first fully absorbable stent to treat coronary artery disease. The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), which releases the drug everolimus to limit the growth of scar tissue, is gradually absorbed by the body in approximately three years.
The U.S. Food and Drug Administration today cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to Carbapenem antibiotics. Carbapenem antibiotics are widely used in hospitals to treat severe infections. These resistant organisms are commonly referred to as […]