The U.S. Food and Drug Administration published a final rule today that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.
Category Archives: Food Safety News
FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products
The U.S. Food and Drug Administration published a final rule today that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.
Whole Foods Market’s Southwest Region recalls Vegan Pumpkin Pie due to Undeclared Walnuts
Whole Foods Market is recalling “Vegan pumpkin pie” produced and sold in the Southwest Region, which includes TX, OK, LA, AR, due to undeclared walnuts.
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FDA allows marketing of non-invasive device to help evaluate heart blood flow
The U.S. Food and Drug Administration today allowed marketing of the HeartFlow FFR-CT software, which permits health care professionals to non-invasively evaluate blood flow in the coronary arteries of patients showing signs and symptoms of coronary artery disease.
URGENT PRODUCT RECALL NOTICE
Acme Smoked Fish Corporation of Brooklyn, NY is voluntarily recalling 564 pounds of its Imported (Product of Denmark) Acme 4oz. (113g) vacuum packs of Smoked Nova Salmon with lot code of L.05122014 because it may be contaminated with Listeria monocytogenes. This organism can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems.
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Flying Cow Creamery Voluntarily Recalls Yogurt
Flying Cow Creamery is voluntarily recalling one lot of whole milk yogurt due to a faulty time and temperature recording during pasteurization. Pasteurization heats milk to eliminate all illness-causing bacteria such as Listeria monocytogenes and Salmonella.
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FDA finalizes menu and vending machine calorie labeling rules
The U.S. Food and Drug Administration today finalized two rules requiring that calorie information be listed on menus and menu boards in chain restaurants, similar retail food establishments and vending machines with 20 or more locations to provide consumers with more nutritional information about the foods they eat outside of the home. The rules are required by the 2010 Patient Protection and Affordable Care Act.
FDA warns against using laparoscopic power morcellators to treat uterine fibroids
Today, the U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.
FDA takes enforcement action against Michigan sandwich company
The U.S. Food and Drug Administration, in a complaint filed by the Department of Justice, is seeking to stop Scotty’s Incorporated, of Detroit, Michigan, which does business as Bruce Enterprises and Bruce’s Fresh Products, and Sandra J. Jackson, the firm’s co-owner and manager, from preparing and distributing ready-to-eat sandwiches.
FDA takes enforcement action against Michigan sandwich company
The U.S. Food and Drug Administration, in a complaint filed by the Department of Justice, is seeking to stop Scotty’s Incorporated, of Detroit, Michigan, which does business as Bruce Enterprises and Bruce’s Fresh Products, and Sandra J. Jackson, the firm’s co-owner and manager, from preparing and distributing ready-to-eat sandwiches.