The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that sterile drug products made by ApotheCure, Inc. and sterile lyophilized (freeze dried powder) drug products made by NuVision Pharmacy were produced under conditions that could create a high potential for contamination. These products should not be administered to patients.
Category Archives: Food Safety News
FDA: U.S. Marshals seize food at New York-based food facility
U.S. Marshals have seized food products at a Ridgewood, N.Y. warehouse that manufactures and distributes kosher food products, after investigators from the U.S. Food and Drug Administration found widespread rodent infestation in the facility.
Wild Blue Yonder Foods issues Recall-Allergy Alert- Undeclared Almonds in Chappaqua Crunch GF Simply Granola with Flax and Fruit
April 12, 2013 – Wild Blue Yonder Foods of Lynn, MA is voluntarily recalling 834 cases of Chappaqua Crunch GF (Gluten Free) Simply Granola with Flax & Fruit because they contain undeclared almonds. People who have an allergy or severe sensitivity to almonds and other tree nuts run the risk of serious or life-threatening allergic reaction if they consume this product.
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FDA budget requests $4.7 billion to ensure safety of food supply and to modernize medical product safety
The U.S. Food and Drug Administration is requesting a budget of $4.7 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2014 budget. Industry user fees would fund 94 percent of the proposed budget increase, including new fees to support the landmark Food Safety Modernization Act (FSMA) and strengthen the FDA’s ability to oversee imported food.
FDA approves Diclegis for pregnant women experiencing nausea and vomiting
The U.S. Food and Drug Administration today approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting.
FDA approves Invokana to treat type 2 diabetes
The U.S. Food and Drug Administration today approved Invokana (canaglifozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.
Publix Issues Voluntary Recall on Publix Deli Tri Fruit and Grain Salad
March 26, 2013 – AKELAND, Fla., – Publix Super Markets is issuing a voluntary recall for Publix Deli Tri Fruit and Grain Salad since it may be adulterated with Listeria monocytogenes. Publix received notification of the potential contamination from their supplier, Allison’s Gourmet Kitchens.
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FDA approves new multiple sclerosis treatment: Tecfidera
The U.S. Food and Drug Administration today approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).
Gold Standard Baking Issues Allergy Alert on Undeclared Walnuts in Sweet P’s Bake Shop Branded Caramel Apple Danish Coffee Cake
Gold Standard Baking of Chicago, IL is recalling 1,134 cases of Sweet P’s Bake Shop branded Caramel Apple Danish Coffee Cake because it contains undeclared walnuts. People who have an allergy or severe sensitivity to walnuts and other tree nuts run the risk of serious or life-threatening allergic reaction if they consume this product.
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FDA issues proposal to improve the quality of automated external defibrillators
The U.S. Food and Drug Administration (FDA) today issued a proposed order aimed at helping manufacturers improve the quality and reliability of automated external defibrillators (AEDs). The proposed order, if finalized, will require manufacturers of these life-saving devices to submit pre-market approval (PMA) applications.