FDA requests removal of Opana ER for risks related to abuse

Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.

Happy Sprout Inc. Recalls Soybean Sprouts Due To Possible Health Risk

Happy Sprout Inc. of Springfield, VA is voluntarily recalling all packages of soybean sprouts because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals 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.

Global Garlic Inc. Recalls "Queso Freso/Whole Milk Cheese" Because of Possible Health Risk

Global Garlic Inc., 11501 NW 107th ST, Miami, FL, is recalling its 16oz packages of “Queso Fresco/ Whole Milk” and (“Queso Fresco x LB(Barra)/Whole Milk Cheese” because they have the potential to be contaminated with Listeria monocytogenes, and 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 stillbirth among pregnant women.

Global Garlic Inc. Recalls "Queso Freso/Whole Milk Cheese" Because of Possible Health Risk

Global Garlic Inc., 11501 NW 107th ST, Miami, FL, is recalling its 16oz packages of “Queso Fresco/ Whole Milk” and (“Queso Fresco x LB(Barra)/Whole Milk Cheese” because they have the potential to be contaminated with Listeria monocytogenes, and 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 stillbirth among pregnant women.

FDA expands use of Sapien 3 artificial heart valve for high-risk patients

The U.S. Food and Drug Administration today approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high or greater.