A proposed U.S. Food and Drug Administration rule would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling.
Category Archives: Food Safety News
FDA approves first generic versions of Aciphex delayed-release tablets to treat GERD
The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).
FDA approves Aptiom to treat seizures in adults
The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.
Garden-Fresh Foods, Inc. Expands Recall Due to Potential Contamination with Listeria Monocytogenes
Garden-Fresh Foods has initiated an expansion of previous recalls of fresh cut vegetables, ready-to-eat salads, slaws, dips and spreads sold under various brands and code dates manufactured prior to November 06, 2013. All packaging types and sizes are included.
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FDA takes step to further reduce trans fats in processed foods
The U.S. Food and Drug Administration announced its preliminary determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” for use in food. The FDA’s preliminary determination is based on available scientific evidence and the findings of expert scientific panels.
Gourmet Express LLC. Voluntarily Recalls 32 Ounce Packages of "Fusia Chicken Lo Mein" and 21 Ounce Packages Of “Bremer 3 Cheese Chicken” and “Bremer Garlic Shrimp" Due to Possible Undeclared Eggs
GOURMET EXPRESS, LLC VOLUNTARILY RECALLS 32 OUNCE PACKAGES OF “FUSIA CHICKEN LO MEIN” AND 21 OZ PACKAGES OF “BREMER 3 CHEESE CHICKEN” AND “BREMER GARLIC SHRIMP SKILLET MEALS DUE TO POSSIBLE UNDECLARED. People who have allergies to egg, run the risk of serious or life-threatening allergic reaction if they consume these products.
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FDA: Janssen Pharmaceuticals, Inc. to plead guilty and pay over $1.6 billion to resolve allegations of misbranding and filing false claims for its schizophrenia drug Risperdal
On behalf of the U.S. Food and Drug Administration, the U.S. Department of Justice today announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) of Titusville, N.J., and a $400 million criminal fine for introducing a misbranded drug, Risperdal (risperidone), into interstate commerce. A Johnson & Johnson Company, JPI must also pay $1.25 billion under a separate civil settlement concerning the same drug. The combined criminal plea and civil settlement agreement related to Risperdal totals $1,673,024 billion.
Reser’s Fine Foods, Inc. Voluntarily Expands Recall of Refrigerated Ready-to-Eat Products Due to Potential Health Risk
Reser’s Fine Foods, Inc. of Beaverton, Oregon is voluntarily expanding its October 22, 2013 recall of refrigerated ready-to-eat products because they may be contaminated with Listeria monocytogenes. Listeria is an organism which can cause serious and sometime fatal infections in young children, frail or elderly people and individuals with weakened immune systems.
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Garden-Fresh Foods, Inc. Expanded Recalls on Specific Packages of Products Because of Possible Health Risk Recall Class I
October 30, 2013 – Garden-Fresh Foods is initiating an expansion to our voluntary recall on various ready-to-eat salads, slaw, and dip products sold under various brands and code dates (see attachment). The products included in the expanded recall were produced between the dates of September 5, 2013 through October 16, 2013.
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FDA approves Gazyva for chronic lymphocytic leukemia
The U.S. Food and Drug Administration today approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).