November 20, 2018
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 […]
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November 20, 2018
First Source of Tonawanda, NY, is voluntarily recalling Chocolate and Nut Tray because it contains undeclared tree nuts, pecan and cashew. People who have an allergy or sensitivity to tree nuts (Pecan & Cashew) run the risk of serious or life-threatening allergic reaction if they consume this product.
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November 20, 2018
FDA issued warning letters issued to two companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine.
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November 20, 2018
FDA provides updates on medical device safety action plan describing recent actions we’ve taken to enhance device safety including implementation of NEST and registries on women’s health.
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November 20, 2018
The FDA approved Gamifant (emapalumab) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH.
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November 19, 2018
FDA issues a qualified health claim for oleic acid oils based on data showing it reduces cholesterols levels.
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November 19, 2018
Jay Robb Enterprises is recalling Jay Robb Unflavored Egg White Protein Product, manufactured by Agropur MSI, LLC of La Crosse, Wisconsin, because it may contain undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. Read The Complete […]
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November 17, 2018
Roche Diagnostics will be proactively replacing all CoaguChek XS PT Test Strips in the United States.
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November 16, 2018
The Quaker Oats Company, a subsidiary of PepsiCo, Inc., today announced a voluntary recall of a small quantity of Cap’n Crunch’s Peanut Butter Crunch cereal due to the potential presence of Salmonella. While the potentially affected product only reached five specific Target stores and is limited to 21 boxes of one variety with two Best […]
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November 16, 2018
Chukar Cherries of Prosser, WA is recalling 7.5oz Amaretto Rainier Chocolate Cherries because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
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November 16, 2018
Routine samples of the Green Cedar Ackawi cheese collected and tested by the U.S. Food and Drug Administration and the Michigan Department of Agriculture and Rural Development tested positive for the presence of Listeria monocytogenes.
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November 16, 2018
FDA approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool.
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November 16, 2018
The U.S. Department of Agriculture and U.S. Food and Drug Administration are announcing that USDA and FDA should jointly oversee the production of cell-cultured food products derived from livestock and poultry.
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November 16, 2018
The FDA is committed to making sure post-market studies are transparent to the public and that industry is fulfilling their PMRs and PMCs.
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November 16, 2018
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to reduce use of animals through a study aimed at eliminating the use of dogs in certain trials
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November 16, 2018
The FDA expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.
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November 15, 2018
New findings from the National Youth Tobacco Survey show that more than 3.6 million middle and high school students were current (past 30 day) e-cigarette users in 2018.
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November 15, 2018
Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes
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November 14, 2018
Nor Cal Food Solutions, LLC of Auburn, CA is announcing a recall of 567 cases of Pumpkin Pesto Tapenade, manufactured by Purveyors Kitchen, because it contains an undeclared tree nut (walnut). People who have an allergy or severe sensitivity to tree nuts (walnuts) run the risk of serious or life-threatening allergic reaction if they consume […]
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