The U.S. Food and Drug Administration today approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
Category Archives: Food Safety News
FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas
The U.S. Food and Drug Administration is reminding health care professionals and consumers about safety concerns with all sterile-use drug products made and distributed by Downing Labs LLC, doing business as NuVision Pharmacy, in Dallas, Texas. Health care professionals should not use any NuVision/Downing Labs sterile products for their patients because the firm cannot ensure the safety or quality of these products. Administration of a non-sterile drug product may result in serious and potentially life-threatening infection or death.
FDA allows marketing of the first test to assess risk of developing acute kidney injury
Today the U.S. Food and Drug Administration allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to help determine if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following the administration of the test. Early knowledge that a patient is likely to develop AKI may prompt closer patient monitoring and help prevent permanent kidney damage or death.
U.S. Marshals seize drug products from Flawless Beauty
Various unapproved and improperly labeled drug products that were marketed, sold and distributed via the Internet by Flawless Beauty LLC, of Asbury Park, New Jersey, have been seized by U.S. Marshals at the request of the U.S. Food and Drug Administration and the U.S. Attorney for the District of New Jersey. These products, including injectable drug products, were marketed, sold and distributed to individuals, retail outlets, health spas and clinics.
FDA approves Keytruda for advanced melanoma
The U.S. Food and Drug Administration today granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.
La Orocovena Biscuit Voluntarily Recalls Pound Cake de Queso Due to Undeclared Milk, Soy and Wheat
Through this means we inform to all La Orocoveña Biscuit clients that we will be conducting a recall of the product Pound Cake de Queso, 2oz. Exp. Dates 08/11/2014 to 10/12/2014, this since the product contains undeclared milk, wheat and soy.
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Tjs Place recalls Basil Pesto Pasta because of potential health risk
Tjs Place of Kirkland Washington is voluntarily recalling approx. 20 containers of Basil Pesto Pasta packed in 8 oz plastic tubs 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. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.
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4C Foods Corp. Voluntarily Recalls 4C Grated Cheese Homestyle Parmesan Because of Salmonella Contamination
4C Foods Corp. is recalling its 6-oz. glass jars of “4C Grated Cheese HomeStyle Parmesan”, UPC 0-41387-32790-8 with code dates BEST BY JUL 21 2016 and JUL 22 2016 due to possible contamination with Salmonella. This recall does not impact any other 4C cheese products. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, elderly people, and others with weakened immune systems.
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Regeneca Worldwide, a Division of Vivaceuticals, Inc Expands the Voluntarily Recall of Regeneslim Appetite Control Capsules Due to the Presence of DMAA that May Pose Possible Health Risk
Regeneca Worldwide a division of VivaCeuticals, Inc. Las Vegas, NV is expanding the voluntary nationwide recall of its RegeneSlim appetite control dietary supplement to include lot #823230415, lot #EX0616r 15813, Lot # EX0616R15814 and Lot #11414re5516 because FDA analysis confirmed the presence of DMAA. DMAA is also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract. DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products.
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Dole Fresh Vegetables Announces Allergy Alert and Voluntary Limited Recall of DOLE-branded Spinach Due to Possible Contamination by Walnuts
Although no illnesses or allergic reactions have been
reported, Dole Fresh Vegetables is initiating a limited voluntary recall of the following products:
This recall is due to possible contamination of these products by walnuts.
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