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.
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.
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.
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 […]
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 […]
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. Read The Complete Story!
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.
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 […]
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. Read The Complete Story!
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 […]
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) […]
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.
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.
Today, the U.S. Food and Drug Administration issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the Drug Quality and Security Act (DQSA), which was enacted in November 2013.
Today, the U.S. Food and Drug Administration issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the Drug Quality and Security Act (DQSA), which was enacted in November 2013.
Evershing International Trading is voluntarily recalling Vinacafe Brand Wake Up Weasel Instant Coffee mix 3-in-1 after learning that the product may contain Sodium Caseinate ( a Milk derivative), a Milk allergen, and Soy extract, a Soy Allergen, that is not declared on the products’ ingredient statement. People who have an allergy or severe sensitivity to […]
The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for […]
The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for […]
Lundberg Family Farms announced that it is voluntarily recalling specific bags of Brown Rice Flour because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems if consumed raw. Healthy persons infected with […]