U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D., today appointed Robert Califf, M.D., a recognized global leader in cardiology, clinical research, and medical economics, as FDA Deputy Commissioner for Medical Products and Tobacco.
The U.S. Food and Drug Administration today approved Natpara (parathyroid horomone) to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 people in the United States.
The U.S. Food and Drug Administration today approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
The U.S. Food and Drug Administration today allowed marketing of the first set of mobile medical apps that allow people with diabetes to automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time using an Apple mobile device such as an iPhone.
Today, the U.S. District Court of the Eastern District of Missouri sentenced Sabahhadin Akman, an owner of the Turkish firm Ozay Pharmaceuticals, to 30 months imprisonment and a $150,000 fine for smuggling counterfeit, misbranded and adulterated cancer treatment drugs into the U.S., including multiple shipments of Altuzan, the Turkish version of Avastin.
The U.S. Food and Drug Administration today approved Cosentyx (secukinumab) to treat adults with moderate-to-severe plaque psoriasis.
Northern Tier Bakery LLC of St. Paul Park, MN is voluntarily recalling Twix Bismarck doughnuts due to the possibility of an undeclared peanut allergen in the Twix topping sourced from a third party. Read The Complete Story!
B&M, Inc. of Mount Vernon, Missouri is recalling certain seasoning blends that contain ground cumin that may contain peanut, an allergen that is not declared on the products’ ingredient statements. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. Read […]
B&M, Inc. of Mount Vernon, Missouri is recalling certain seasoning blends that contain ground cumin that may contain undeclared peanut protein, an allergen that is not declared on the product’s ingredient statements. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these […]
A California dietary supplement manufacturer was ordered by a federal court to stop selling its products until the company comes into compliance with the U.S. Food and Drug Administration’s dietary supplement manufacturing regulations and other requirements listed in the consent decree.
H-E-B has issued a voluntary and precautionary recall specifically for the H-E-B Homestyle White Corn Tortillas due to the possible presence of foreign material. There have been no reported illnesses related to this precautionary recall. Read The Complete Story!
Gilster-Mary Lee of Chester, Illinois, is voluntarily recalling one lot of Market Pantry Honey & Oat Mixers Ready to Eat cereal because it may contain undeclared almonds. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume these products. Read The Complete Story!
The U.S. Food and Drug Administration today approved the Maestro Rechargeable System for certain obese adults, the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness.
Zenobia Company LLC. Of Yonkers, NY is recalling MY Spice Sage Cumin Ground in its 1 oz, 4 oz, 4.9 oz, 16 oz and 50 pound packages, because they may contain undeclared peanut protein. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. Read […]
The Santa Barbara Smokehouse Inc. of Santa Barbara, CA, is voluntarily recalling the following brands and batches of cold smoked salmon produced and packed between December 17th and December 24th 2014 because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, […]
The U.S. Food and Drug Administration today approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
H-E-B has issued a voluntary and precautionary recall for H-E-B Single Serving Tortilla Soup and H-E-B Single Serving Poblano Corn Chowder due to undeclared peanut allergens in seasoning provided by Southern Style Spices. There have been no reported illnesses related to this precautionary recall. Read The Complete Story!
Whole Foods Market is recalling its Assorted Cookie Platters, All Sizes for the presence of an undeclared nut allergens. The recalled cookie platters were sold in Whole Foods Market stores in Arizona, Southern California, Hawaii and Nevada in a round, clear plastic container with black plastic base and Whole Foods Market label beginning November 24, […]
The U.S. Food and Drug Administration today granted the first waiver to allow a nucleic acid-based test, the Alere i Influenza A & B test, to be used in a greater variety of health care settings. The test was previously only available for use in certain laboratories.