Bayou Brothers of Austin, Texas is recalling its 33 oz. jars of its Bayou Brothers Creole Sauce because it contains undeclared fish. People who have an allergy or severe sensitivity to fish may run the risk of a serious or life-threatening allergic reaction if they consume this product.
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Category Archives: Food Safety News
Statement from FDA Commissioner Robert Califf, M.D. on the release of the final individual patient expanded access form
Today, the U.S. Food and Drug Administration finalized its efforts to streamline the process used by physicians to request expanded access, often called “compassionate use,” to investigational drugs and biologics for their patients. As a physician, I understand the importance of being able to access investigational treatments for a patient when there are no other options to treat their serious disease or condition.
FDA approves new diagnostic imaging agent to detect rare neuroendocrine tumors
The U.S. Food and Drug Administration today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs).
FDA approves new diagnostic imaging agent to detect rare neuroendocrine tumors
The U.S. Food and Drug Administration today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs).
FDA takes action against Kansas food manufacturer for repeated food safety violations
The U.S. District Court for the District of Kansas entered a consent decree of permanent injunction today between the United States and Native American Enterprises, LLC, located in Wichita, Kansas; its part-owner, William N. McGreevy; and its production manager, Robert C. Conner.
FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer
The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients. Such mutations are present in approximately 10-20 percent of non-small cell lung cancers (NSCLC).
FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer
The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients. Such mutations are present in approximately 10-20 percent of non-small cell lung cancers (NSCLC).
FDA issues draft guidance to food industry for voluntarily reducing sodium in processed and commercially prepared food
Today, the U.S. Food and Drug Administration issued draft guidance for public comment that provides practical, voluntary sodium reduction targets for the food industry. Average sodium intake in the U.S. is approximately 3,400 mg/day. The draft short-term (two-year) and long-term (10-year) voluntary targets for industry are intended to help the American public gradually reduce sodium intake to 2,300 milligrams (mg) per day, a level recommended by leading experts and the overwhelming body of scientific evidence. The targets are also intended to complement many existing efforts by food manufacturers, restaurants, and food service operations to reduce sodium in foods.
Expanded Voluntary Recall on Certain Backroad Country Brand Sunflower Kernel Products
Troyer® Cheese Inc, under advice from its packaging facility concerning, CRANBERRY NUT DELIGHT MIX PREPACK, HONEY ISLAND CRUNCH MIX PREPACKAGED, PRETZELS PEANUT BUTTER PREPACKAGED, WALNUT HALVES/PIECES PREPACKAGED, SUNFLOWER SEEDS R&S PREPACKAGED AND SUNFLOWER SEEDS R&S BULK 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.
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FDA approves Ocaliva for rare, chronic liver disease
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.