FDA issues update to Benefit-Risk Assessment plan as part of efforts to enhance the patient perspective and experience in drug development and review
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Health Nut Factory Recalls Organic Coconut Smiles Because Of Possible Health Risk
Healthy Nut Factory of Bayside, NY is recalling 7 oz. Pouches of Organic Coconut Smiles because it has 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.
Target Corporation Issues a Voluntary Recall For a Variety of Frozen Products Sold at a Single Store on Oahu
Target Corp. (NYSE: TGT) is voluntarily recalling a number of frozen items sold at a single Target store on Oahu located at 1450 Ala Moana Blvd., Honolulu, Hawaii. The products were not held at an appropriate temperature and may be contaminated by spoilage organisms or pathogens, which could lead to serious or life-threatening illness if consumed. The recall includes items listed here (Item Listlink)) that were sold on March 23, 2018 through March 27, 2018. No illnesses have been reported to date.
FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse
FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse
Federal judge approves consent decree with New York dietary supplement manufacturer Riddhi USA
A New York dietary supplement manufacturer has been ordered by a federal court to stop selling its products until the company comes into compliance with the FDA’s dietary supplement manufacturing regulations.
Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs
Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs
First Source Issues Allergy Alert on Undeclared Peanuts in Wegmans 9 Oz Yogurt Raisins
First Source of Tonawanda, NY, is voluntarily recalling 9 OZ packages of Wegmans Yogurt Raisins, because the product may contain undeclared peanuts. People who have an allergy or sensitivity to peanuts run the risk of serious or life- threatening allergic reaction if they consume this product.
FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices
The authorization classifies integrated continuous glucose monitoring devices in class II and subjects them to certain criteria called special controls
eBars Issues Allergy Alert on Undeclared Allergens
eBars LLC of Franklin, Tenn. is issuing a voluntary recall on its line of products that may contain undeclared peanut and/or almond allergens.
Darwin’s Natural Pet Products Issues Voluntary Recalls for Darwin’s Brand Dog Foods Due To Contamination Salmonella And Shiga Toxin-Producing Escherichia Coli O128
Darwin’s Natural Pet Products of Tukwila, Wash., a manufacturer of fresh raw meals for dogs, today announced it is voluntarily recalling a total of four lots of products after testing showed that some of the Chicken and Duck with Organic Vegetables Meals for Dogs may contain Salmonella, and the Turkey with Organic Vegetables Meals for Dogs sample may contain Salmonella and E. coli O128. These pathogens can cause serious and sometimes fatal infections.