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 walk with assistance from a trained companion, such as a spouse or home health aide.
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Kentucky oncology practice and its manager plead guilty to purchasing and selling unapproved chemotherapy drugs
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 brought by the U.S. Attorney’s Office for the Eastern District of Kentucky.
Doctor’s Best Issues Voluntary Nationwide Recall of Red Yeast Rice due to Undeclared Lovastatin
Doctor’s Best is voluntarily recalling lot 3121005 (7379 bottles) of Red Yeast Rice dietary supplement, 600 mg Capsules, 120-count bottles to the retail level.
FDA issues guidance to support the responsible development of nanotechnology products
Today, three final guidances and one draft guidance were issued by the U.S. Food and Drug Administration providing greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.
Producer of tainted dietary supplements sentenced in federal court
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 Voluntarily Recalls Small Quantity of Velveeta Original
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.
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FDA approves Sivextro to treat skin infections
The U.S. Food and Drug Administration today approved Sivextro (tedizolid phosphate), a new antibacterial drug, to treat adults with skin infections.
NDC Implements Voluntary Recall of the Hydrofinity™ Hydrophilic Guidewire
Nitinol Devices & Components, Inc. (NDC) announced today a voluntary recall of its HydroFinity™ Hydrophilic Guidewires. The HydroFinity Guidewire is a product developed and manufactured by NDC and distributed by Covidien.
Vita Food Products Issues Voluntary Recall of 4oz Vita Classic Premium Sliced Smoked Atlantic Salmon Due to Possible Health Risk
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 people, and others with weakened immune systems. Healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea.
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Hospira Announces Voluntary Nationwide Recall of One Lot of 0.5% Marcaine™ (Bupivacaine HCI Injection, USP), 30 ML, Single-Dose, Preservative-Free Vial Due to Visible Particulates
Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary nationwide recall to the user level for one lot of 0.5% Marcaine™ (Bupivacaine HCl Injection, USP), 30 mL, Single-dose Vial – Preservative Free (NDC 0409-1560-29), Lot 33-545-DD. The recall is due to a confirmed customer report of particulate embedded in the glass vial as well as visible particulate in the solution.