The U.S. Food and Drug Administration today approved Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body.
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Ocean Group, Inc. Announces Recall of Ocean Brand Masago Lake Smelt Roe for Undeclared Allergens
Los Angeles, CA -Ocean Group, Inc. of Los Angeles, CA is recalling Ocean brand Masago Lake Smelt Roe product because product labels failed to declare food allergens Wheat and/or Soy, in their ingredient statements. People who have an allergy or severe sensitivity to wheat or soy run the risk of a life threatening allergic reaction, anaphylaxis, that requires immediate medical attention should they consume this product.
FDA approves new orphan drug to treat pulmonary arterial hypertension
On December 21, the U.S. Food and Drug Administration approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation.
The Swinomish Fish Company Voluntarily Recalls Native Catch Salmon Bacon Because of a Possible Health Risk
The Swinomish Fish Company is initiating a voluntary recall of packages of both Traditional and Peppered flavors of NATIVE CATCH SALMON BACON with a “BEST BY” date of 1/23/16 and 3/16/16 distributed in the Western Washington and Florida areas. The Native Catch Salmon Bacon has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death.
FDA updates blood donor deferral policy to reflect the most current scientific evidence and continue to ensure the safety of the U.S. blood supply
Today the U.S. Food and Drug Administration issued a final guidance outlining updated donor deferral recommendations that appropriately protect the U.S. blood supply by reducing the risk of transmitting human immunodeficiency virus (HIV) infection.
Mars Chocolate North America Issues Allergy Alert Voluntary Recall on Undeclared Peanuts, Wheat and Egg Ingredient for DOVE® Chocolate Assortment Snowflakes, 24.0 oz. Bag, Sold Only at One Major Retailer with Stores Across the U.S.
Today, Mars Chocolate North America announced a voluntary recall of its DOVE® Chocolate Assortment Snowflakes, 24.0 oz. bag – this is a seasonal item only sold at one major retailer with stores across the U.S.
Item# 10139802 – UPC# 400050521
LOT CODE: 537CG4PA30, 537DG4PA30, 538AG4PA30, 538AM4PA30, 541AG4PA20, 542EM4PA20
SmartLipo365 Issues Voluntary Nationwide Recall of Smart Lipo Due to Undeclared Sibutramine, Desmethylsibutramine and Phenolphthalein
SmartLipo365 is voluntarily recalling all lots of Smart Lipo (800, 900, 950 mg) capsules, to the consumer level. FDA’s analysis found the Smart Lipo products to contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010.
Voluntary Recall Notice for Zatarain’s Red Beans and Rice Original due to Possible Health Risk from Undeclared Ingredients
Zatarain’s is initiating a voluntary recall of 8 oz boxes of Red Beans and Rice Original with a “BEST BY” date of JUL 31 16Z distributed in the Midwest and Eastern regions of the U.S. The Red Beans and Rice Original product may actually contain Creamy Parmesan Rice Mix with dairy ingredients.
FDA permits marketing of fecal continence restoration system
The U.S. Food and Drug Administration today approved the Fenix Continence Restoration System to treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options.
FDA proposes tanning bed age restrictions and other important safety measures
Today, the U.S. Food and Drug Administration announced important proposed steps to protect public health by preventing the use of sunlamp products (also commonly known as indoor tanning beds) by minors and reducing the risk of using these devices for adults. The FDA is committed to protecting public health by informing consumers of the risks of indoor tanning.