FDA Alerts
FDA: Neptune Manufacturing Must Take Steps to Safely Produce Seafood
On December 1, a federal judge from the U.S. District Court for the Central District of California entered a consent decree of permanent injunction against Neptune Manufacturing, Inc., of Los Angeles, and its owners, Alexander Goldring, Peter Oyrekh and Semyon Krutovsky.
FDA Approves Rx for Bone Marrow Disease
The U.S. Food and Drug Administration today approved a new use for Jakafi (ruxolitinib) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Jakafi is the first drug approved by the FDA for this condition.
FDA Approves Blincyto to Treat Rare Form of Leukemia
The U.S. Food and Drug Administration today approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.
FDA: Slim-Vie Contains Hidden Drug Ingredient
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Slim Vie, a product promoted and sold for weight loss on various websites, and possibly in some retail stores.
Case of Rare Brain Infection Reported in MS Patient Taking Tecfidera
FDA is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate) developed a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML), and later died.
FDA: Sexual Enhancement Product Contains Hidden Drug Ingredient
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Black Storm, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.
FDA Warns Consumers Not to Buy Weight Loss Product
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Super Extreme Accelerator, a product promoted and sold for weight loss on various websites, and possibly in some retail stores.
FDA: "Feng Shi Ling" Contains Undeclared Drug Ingredients
The Food and Drug Administration is advising consumers not to purchase or use “Feng Shi Ling,” a product promoted and sold as an herbal medication for arthritic pain associated with rheumatoid arthritis and osteoporosis.
FDA Recommends Adding Boxed Warning to Laparoscopic Power Morcellators
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.
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.