The U.S. Food and Drug Administration (FDA) has released two separate draft guidance documents: the first provides guidance on how companies will comply with the requirement to report on the quantities of potentially harmful chemicals in tobacco products, and the second provides guidance to companies that seek to advertise or market a tobacco product as less harmful or associated with reducing the risk of tobacco-related disease.
Category Archives: Food & Drug Recalls
The Hartz Mountain Corporation Recalls Four Lots of Wardley Advanced Nutrition Perfect Protein Tropical Flake Fish Food Because of Possible Salmonella Health Risk
The Hartz Mountain Corporation, located in Secaucus, N.J. is voluntarily recalling product from four specific lots of Wardley Advanced Nutrition Perfect Protein Tropical Flake Fish Food 1 oz. size due to concerns that one or more containers within the specified lots may have been potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall.
South Florida Produce, LLC. Recalls Jalapeno Peppers Because of Possible Health Risk
South Florida Produce, LLC is recalling Jalapeno Peppers, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.Â
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FDA to discuss risks and benefits of metal-on-metal hip replacements
The U.S. Food and Drug Administration today announced that it is seeking expert scientific and clinical advice on the risks and benefits of metal-on-metal (MoM) hip systems as well as potential patient and practitioner recommendations on the use of MoM hip systems and the management of patients implanted with such devices. FDA will discuss these issues at a two-day expert advisory panel meeting on June 27-28, 2012.
FDA pursues enforcement action against California fish processor
The U.S. Food and Drug Administration, in a complaint filed by the Department of Justice, is seeking to stop the processing and distribution of fish products at a California company because of a risk of botulism and other food hazards. If granted, the permanent injunction against Fujino Enterprises Inc., doing business as Blue Ocean Smokehouse, of Half Moon Bay, Calif., would stop the company from processing and distributing fish and fish products.
U.S. Marshals seize unapproved and misbranded drug products at Missouri distributor
Dara Corrigan, associate commissioner for regulatory affairs for the U.S. Food and Drug Administration, and David M. Ketchmark, Acting U.S. Attorney for the Western District of Missouri, announced today that U.S. Marshals have seized drugs being held by Notions-n-Things Distribution of Bogard, Mo.
Topnotch Cookies & Cakes Issues Allergy Alert On Undeclared Milk In Chocolate Chip Chunk Cookies
Topnotch Cookies & Cakes of Westland, MI is recalling 550 Chocolate Chip Chunk Cookies because it may contain undeclared traces of milk in the “butter vanilla flavor” “containing milk ingredients”. People who have an allergy or severe sensitivity to milk run the risk of life-threatening allergic reaction if they consume the product.
Castellini Company LLC Recalls Jalapeno Peppers Because Of Possible Health Risk
Castellini Company LLC is recalling certain jalapeno peppers distributed from its
Wilder, Kentucky facility because they have the potential to be contaminated with Salmonella, an organism
which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others
with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea
(which may be bloody), nausea, vomiting and abdominal pain.
Club Chef LLC Recalls Salsa Because Of Possible Health Risk
Club Chef LLC is recalling its 12 oz., 16 oz. and 5 lb. Salsa products because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
New FDA guidance on considerations used in device approval, de novo decisions
The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of certain medical devices are considered during pre-market review.