FDA Alerts
FDA Adds Important Safety Information to Xolair Label
An FDA review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair (omalizumab) than in those who were not treated with Xolair.
Company Recalls Butternut Squash Ravioli Due to Undeclared Allergens
Carmel Food Group today issued a voluntary recall of Rising Moon Organics Butternut Squash Ravioli, a frozen product, because of mixed product in the packages with SELL BY APR 09 2015 (ONLY).
Whole Foods Recalls Pre-Packaged Salads for Undeclared Allergens
Whole Foods Market is recalling mini 4oz. containers of pre-packaged Caesar salad and Mesclun Goat Cheese salad sold in stores on July 8, 2014 throughout New York, New Jersey (Excluding Princeton, Cherry Hill and Marlton) and Connecticut (Excluding Glastonbury, West Hartford and Bishop’s Corner).
New Treatment Approved for Ragweed Allergy
The FDA today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age.
FDA Issues Draft Guidance to Accurately Label Medical Products Not Made with Natural Rubber Latex
The US Food and Drug Administration today issued draft recommendations to medical product manufacturers for providing consumers with accurate information about products that are not made with natural rubber latex (NRL).
Andy Capp’s Hot Fries Recalled Due To Undeclared Soy Allergen
Today, ConAgra Foods, Omaha, Neb., in cooperation with the US Food and Drug Administration (FDA) is voluntarily recalling a limited number of packages of its Andy Capp’s Hot Fries flavor product that may contain the Andy Capp’s Cheddar Fries flavor, and, therefore, an undeclared allergen—soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products. There have been no illnesses reported to date in connection with this product.
FDA Approves Generic Singulair
The US Food and Drug Administration approved the first generic versions of Singulair (montelukast sodium) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.
US Nutrition Issues Allergy Alert
US Nutrition, of Ronkonkoma , New York is recalling Daily Multiple for Women 50 + Tablets, because certain lots contain undeclared fish (fish gelatin). People who have an allergy or severe sensitivity to fish run the risk of a serious or life-threatening allergic reaction if they consume these products.