One 8-9 lb wheel of “Royal Blue Stilton” cheese contained in a master case with batch code B038 has been recalled by Atalanta Corporation, an Elizabeth, New Jersey based food distributor, because the product has 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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Federal government takes action against drug manufacturer and distributor
H&P Industries, Triad Group, and company officers agree to correct deficiencies
FDA approves Potiga to treat seizures in adults
On June 10, Potiga (ezogabine) tablets were approved by the U.S. Food and Drug Administration for use as an add-on medication to treat seizures associated with epilepsy in adults.
Potiga was approved for the treatment of partial seizures, the most common type of seizure seen in people with epilepsy.
FDA approves redesigned labels for some Merck drugs
The U.S. Food and Drug Administration today is announcing the approval of Merck’s redesigned drug container labels that include a new standardized format to improve readability and provide better information on product and strength differentiation.
FDA clears new system to perform simultaneous PET, MRI scans
The U.S. Food and Drug Administration today cleared the Siemens Biograph mMR system, the first device to simultaneously perform a positron emission tomography scan, commonly known as PET scan, and a magnetic resonance imaging (MRI) scan.
FDA takes ‘first step’ toward greater regulatory certainty around nanotechnology
The U.S. Food and Drug Administration today released draft guidance to provide regulated industries with greater certainty about the use of nanotechnology, which generally involves materials made up of particles that are at least one billionth of a meter in size. The guidance outlines the agency’s view on whether regulated products contain nanomaterials or involve the application of nanotechnology.
FDA announces new safety recommendations for high-dose simvastatin
The U.S. Food and Drug Administration today is announcing safety label changes for the cholesterol-lowering medication simvastatin because the highest approved dose–80 milligram (mg)–has been associated with an elevated risk of muscle injury or myopathy, particularly during the first 12 months of use.
FDA: Pfizer will voluntarily suspend sale of animal drug 3-Nitro
The U.S. Food and Drug Administration today announced that Alpharma, a subsidiary of Pfizer Inc., will voluntarily suspend U.S. sales of the animal drug 3-Nitro (roxarsone), a product used by poultry producers since the 1940s.
US NUTRITION Issues Allergy Alert On Undeclared Fish In Daily Multible For Women 50 + Tablets
US Nutrition, of Ronkonkoma, New York is recalling Daily Multiple for Women 50 + Tablets, because certain lots contain undeclared Fish (fish gelatin). People who have an allergy or severe sensitivity to Fish run the risk of a serious or life-threatening allergic reaction if they consume these products.
FDA: DDS probiotic products seized
U.S. Marshals, at the request of the U.S. Food and Drug Administration, today seized probiotic products from UAS Laboratories, Inc., of Eden Prairie, Minn. because the company markets the products as drugs.