Following a rigorous, science-based review, the U.S. Food and Drug Administration announced today that for the first time it has authorized the marketing of new tobacco products through the premarket tobacco application (PMTA) pathway. This action permits the tobacco products to be sold in the U.S., but does not mean that they are safe or “FDA approved.” All tobacco products are potentially harmful and addictive and those who do not use tobacco products should continue to abstain from doing so.
FDA approves Cotellic as part of combination treatment for advanced melanoma
The U.S. Food and Drug Administration today approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation).
Brett Anthony Foods Issues Allergy Alert on Undeclared Chestnuts in Whole Foods Brand Wild Mushroom Soup Sold in Illinois, Indiana, Michigan, Missouri, Minnesota and Nebraska Stores
Brett Anthony Foods of Elk Grove Village Illinois is recalling 109, 24oz cups of Wild Mushroom Soup because it may contain undeclared chestnuts. People who have an allergy or severe sensitivity to chestnuts run the risk of serious or life-threatening allergic reaction if they consume these products.
Inaffit, LLC Issues Voluntary Nationwide Recall of Natureal Due to Undeclared Sibutramine
Inaffit, LLC is voluntarily recalling all lots of Natureal light green and dark green capsules to the consumer level after FDA laboratory testing found Natureal to contain sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010.
Zenobia Company LLC. Recalls Ground Flax Seed Meal Because of Possible Health Risk
Zenobia Company LLC. of Yonkers, NY is recalling Ground Flax Seed Meal, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
Blue Buffalo Company, Ltd. Voluntarily Recalls Limited Production of Kitty Yums Chicken Recipe Cat Treats Due to the Presence of Propylene Glycol
Blue Buffalo Company, Ltd. is voluntarily recalling a limited production of Blue Kitty Yums Chicken Recipe Cat Treats that may contain low levels of propylene glycol, which is not permitted by the FDA for use in cat food. Cats reacting to high doses of propylene glycol may exhibit signs of depression and may have a loss of coordination, muscle twitching, and excessive urination and thirst.
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Brett Anthony Foods Issues Allergy Alert on Undeclared Peanut, Egg, Sulfite in Whole Foods Brand Tofu Curry Cous Cous Box 16oz
Brett Anthony Foods of Elk Grove Village Illinois is recalling two 16oz containers of Tofu Curry Cous Cous Box because it may contain undeclared peanut, egg, sulfite. People who have an allergy or severe sensitivity to peanut, egg, sulfite run the risk of serious or life-threatening allergic reaction if they consume these products.
World Variety Produce, Inc. Voluntarily Recalls Italian Pine Nuts Because of Possible Health Risk
World Variety Produce, Inc. of Los Angeles, CA is voluntarily recalling Italian Pine Nuts 2oz and 3oz, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever,diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
Kozy Shack Recalls One Lot of Kozy Shack Indulgent Recipe Pudding
Kozy Shack Enterprises LLC is recalling one lot of Kozy Shack Indulgent Recipe Pudding in a Salted Caramel cardboard sleeve because it may contain Vanilla Bean Pudding cups, which contain egg. The Salted Caramel cardboard sleeve does not include egg in the ingredient statement.
Peru Food Imports, Inc. Issues Allergy Alert on Undeclared Sulfites in Mote Corn-Maiz Mote, Lot# 38-16
Peru Food Imports Inc. of Fairview, NJ is recalling Peru Food Mote Corn-Maiz Mote, Lot #38-16 because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.