Triceutical, Inc., of Farmingdale, New York, and Liqun Zhang, the company’s president, have agreed to stop production and distribution of dietary supplements under the terms of a consent decree because of violations of federal dietary supplement regulations, known as Current Good Manufacturing Practice (cGMP) requirements.
The U.S. Food and Drug Administration today approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action was taken under the agency’s accelerated approval program.
A federal judge in New York has signed a consent decree for permanent injunction between the United States and Mira Health Products Ltd., a dietary supplement manufacturer located in Farmingdale, New York, and Michael S. Ragno and Michael S. Ragno, Jr.
On June 25, the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede, Inc. (Laclede) of Rancho Dominguez, California, and its president, Michael A. Pellico. The complaint claims that Laclede illegally […]
Flowers Foods (NYSE: FLO) is voluntarily recalling the following brands of Bar-B-Q bread because they may contain undeclared milk. People who have allergies to dairy products run the risk of serious or life-threatening allergic reaction if they consume these products. No illnesses have been reported to date. Read The Complete Story!
Today, the U.S. Food and Drug Administration issued several policy documents regarding compounded drug products for human use, as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. The policy documents consist of a draft interim guidance, a proposed rule, a […]
The U.S. Food and Drug Administration today approved Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal.
The U.S. Food and Drug Administration today allowed marketing of the first motorized device intended to act as an exoskeleton for people with lower body paralysis (paraplegia) due to a spinal cord injury. ReWalk is a motorized device worn over the legs and part of the upper body that helps an individual sit, stand, and […]
Hematology and Oncology Center (HOC) PLLC of Somerset, Kentucky has pleaded guilty to federal charges that the firm purchased and sold unapproved and improperly labeled chemotherapy drugs. HOC’s former office manager, Natarajan Murugesan, also pleaded guilty to assisting with these activities, which are violations of the Federal Food, Drug, and Cosmetic Act. The charges were […]
Today, three final guidances and one draft guidance were issued by the U.S. Food and Drug Administration providing greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.
Nikki Haskell, the owner and chief executive officer of Balanced Health Products (BHP), has been sentenced by a United States magistrate judge in Manhattan federal court to a $60,000 fine for distributing dietary supplements that contained a prescription drug.
Kraft Foods Group is voluntarily recalling 260 cases of Velveeta Original Pasteurized Recipe Cheese Product because it does not contain appropriate levels of sorbic acid, a preservative ingredient. While unlikely, the affected product could spoil prematurely and/or lead to food borne illness. Read The Complete Story!
The U.S. Food and Drug Administration today approved Sivextro (tedizolid phosphate), a new antibacterial drug, to treat adults with skin infections.
Chicago, Illinois – June 16, 2014 – Vita Food Products, Inc. of Chicago, Illinois is notifying the public that it is recalling 1,878 pounds of Vita Classic Premium Sliced Smoked Atlantic Salmon due to possible contamination of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly […]
DOMEGA NY INTERNATIONAL CO LTD, 47-57 BRIDGEWATER STREET BROOKLYN NY 11222 is recalling Gong xiFacai gift chocolates because it contains undeclared peanuts and milk. Consumers who have allergies to peanuts and milk run the risk of serious or life-threatening allergic reactions if they consume this product. Read The Complete Story!
The U.S. Food and Drug Administration today approved a new use for Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic imaging agent used to help doctors determine the extent a type of cancer called squamous cell carcinoma has spread in the body’s head and neck region.
Fish Family Farm, Inc. of Bolton, CT is voluntarily recalling milk products and cream because as a precautionary measure they may be adulterated with peanut and tree nut (pistachio) allergens. People who have an allergy or severe sensitivity to peanuts or tree nuts (pistachios) run the risk of serious or life-threatening allergic reaction if they consume […]
The U.S. Food and Drug Administration and the U.S. Environmental Protection Agency today issued updated draft advice on fish consumption. The two agencies have concluded pregnant and breastfeeding women, those who might become pregnant, and young children should eat more fish that is lower in mercury in order to gain important developmental and health benefits. […]
The U.S. Food and Drug Administration today approved Eloctate, Antihemophilic Factor (Recombinant), Fc fusion protein, for use in adults and children who have Hemophilia A. Eloctate is the first Hemophilia A treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.