Today the U.S. Food and Drug Administration granted accelerated approval for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as a single therapy in adults unable to tolerate UDCA.
Whole Foods Market store in California issues consumer advisory on kimchi products due to undeclared food allergens
Whole Foods Market is issuing an advisory to customers who purchased Spicy Kimchi, White Kimchi, Kimchi Fried Rice and Kimchi Guacamole from one of its Los Angeles-area stores because the items contained fish, shellfish or tree nuts (pine nuts) that were not listed on product labels. All potentially affected products have been removed from store shelves, and the company is recalling the items out of an abundance of caution. People who have an allergy or severe sensitivity to tree nuts, fish or shellfish run the risk of serious or life-threatening allergic reaction if they consume these products.
Sweet Earth Natural Foods Issues Voluntary Recall of Mispackaged Big Sur Burritos That Contain the Santa Cruz Burrito: Potential Allergy Concern for Those with Milk Allergy
Sweet Earth Natural Foods is voluntarily recalling its Big Sur Burrito, 7 oz, due to a packaging error. As a result, a small number of these products contain an undeclared milk allergen.
Sid Wainer and Son Recalls Domaine de Provence La Cucina Tart Shells and Domaine de Provence Neutral 3" Cone Tart Shells Due to Undeclared Allergens
Sid Wainer & Son of New Bedford, MA is voluntarily recalling Domaine de Provence La Cucina Tart Shells and Domaine de Provence Neutral 3� Cone Tart Shells due to undeclared allergens. People who have an allergy or severe sensitivity to Tree Nuts, specifically Coconut and Eggs run the risk of a serious or life-threatening allergic reaction if they consume these products.
FDA approves Zinbryta to treat multiple sclerosis
The U.S. Food and Drug Administration today approved Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a long-acting injection that is self- administered by the patient monthly.
FDA approves new diagnostic imaging agent to detect recurrent prostate cancer
The U.S. Food and Drug Administration today approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment.
FDA approves first buprenorphine implant for treatment of opioid dependence
The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.
Voluntary Recall On Certain Backroad Country Brand Sunflower Kernel Products
Millersburg, OH – Troyer Cheese Inc, under advice from its packaging facility concerning, CRANBERRY NUT DELIGHT MIX PREPACK, HONEY ISLAND CRUNCH MIX PREPACKAGED, PRETZELS PEANUT BUTTER PREPACKAGED, and WALNUT HALVES/PIECES PREPACKAGED, is recalling a limited number of products that have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.
FDA issues final food defense regulation
The U.S. Food and Drug Administration today finalized a new food safety rule under the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) that will help to prevent wide-scale public health harm by requiring companies in the United States and abroad to take steps to prevent intentional adulteration of the food supply. While such acts are unlikely to occur, the new rule advances mitigation strategies to further protect the food supply.
C. J. Dannemiller Co. Annouces Recall of "Sunflower Kernels, Roasted and Salted" and "Sunflower Kernels, Roasted No Salt" Because of Possible Listeria monocytogenes
C. J. Dannemiller Co. is recalling SunOpta 50# bags and 30# cases of roasted sunflower kernels roasted and salted, and sunflower kernels roasted no salt because they have the potential to be contaminated with Listeria.