Today, U.S. District Judge Kathleen M. Williams for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Stratus Pharmaceuticals Inc. of Miami, Florida, Sonar Products Inc. of Carlstadt, New Jersey and two of the companies’ officers, Alberto Hoyo and Juan Carlos Billoch.
Category Archives: Food Safety News
Gomacro Recalls Limited Number of Macrobars and Thrive Bars Because of Possible Health Risk
GoMacro, of Viola, Wis., is recalling a limited number of MacroBars and Thrive Bars because they 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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Statement from FDA Commissioner Scott Gottlieb, M.D. – FDA is taking new steps to help assess opioid drugs with abuse-deterrent properties
Last month, I asked my colleagues at the FDA to identify what additional and more forceful steps the FDA can take, on top of the vigorous work the agency is already doing, to address the crisis of opioid addiction. Everyone at the FDA is committed to focusing on all aspects of the epidemic. The new policy steps that we announced included the formation of a steering committee to examine additional regulatory and policy actions that we can take to combat this crisis. This steering committee will place particular emphasis on evaluating efforts we can take to reduce the number of new cases of addiction.
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.
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.
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.
Gilster-Mary Lee Corp. Issues a Recall For Undeclared Egg Noodles in Western Family Onion Soup Mix
Gilster-Mary Lee of Chester, Illinois, is voluntarily recalling one lot of Western Family Onion Soup Mix, UPC 15400-03604 because it may contain undeclared egg. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.
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Gilster-Mary Lee Corp. Issues a Recall For Undeclared Egg Noodles in Western Family Onion Soup Mix
Gilster-Mary Lee of Chester, Illinois, is voluntarily recalling one lot of Western Family Onion Soup Mix, UPC 15400-03604 because it may contain undeclared egg. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.
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FDA approves first generic Strattera for the treatment of ADHD
The U.S. Food and Drug Administration today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.
Caverflo.com Issues Voluntary Nationwide Recall of Caverflo Natural Herbal Coffee due to the Presence of Undeclared Active Pharmaceutical Ingredients and Undeclared Milk
Caverflo.com is voluntarily recalling all lots of Caverflo Natural Herbal Coffee, 25 grams to the consumer level. FDA laboratory analysis confirmed the presence of Sildenafil and Tadalafil which are the active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED). Caverflo.com has received a report of an individual death after use of the coffee. Caverflo Natural Herbal Coffee may also contain undeclared milk.
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