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.
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.
FDA approves additional blood test for viruses linked to leukemia, neurologic diseases
Avioq HTLV-I/II Microelisa System, a test designed to detect antibodies to viruses in donors of human blood and blood components that are associated with several diseases, including some forms of leukemia and neurologic diseases, was approved today by the Food and Drug Administration.
FDA approves Omontys to treat anemia in adult patients on dialysis
The U.S. Food and Drug Administration today approved Omontys (peginesatide) to treat anemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD).
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.
El Ranchero Del Sur, LLC. Recall (Esta Piendo Devolución) Queso Fresco El Ranchero Del Sur, Queso Fresco En Hoja De Platano Los Corrales, Y Queso Hebra Queso Oaxaca El Ranchero Del Sur Debido A Posible Reigos De Salud
El Ranchero Del Sur, LLC. de South River, en el estado de Nueva Jersey está pediendo que devuelvan todos los productos Queso Fresco El Ranchero Del Sur de 14 onzas, Queso Fresco en Hoja de Plátano Los Corrales de 14 onzas, Queso Hebra Queso Oaxaca El Ranchero Del Sur de 14 onzas, y de 10 libras porque pueden estar potencialmente contaminados con Listeria monocytogenes, un organismo que puede causar graves y a veces infecciones mortales en niños pequeños, personas con estado de salud delicado, ancianos y personas con el sistema inmunológico débil. Aunque algunos individuos sanos pueden sufrir solo a corto plazo sÃntomas como fiebre alta, dolor de cabeza severo, rigidez, nauseas, dolor abdominal y diarrea, las infecciones de Listeria pueden causar abortos espontáneos y partos prematuros entre las mujeres embarazadas.
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Eagle Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 4 Lots of Argatroban Injection 50 mg/50 mL (1 mg/mL) Due to a Potential for Visible Particulates. NDC# 42367-203-07 (single unit) NDC# 42367-203-84 (10 pack)
The Medicines Company's supplier, Eagle Pharmaceuticals Inc., has issued a voluntary recall of all four (4) lots of Argatroban Injection, 50 mg per 50 mL ("Argatroban") from the market due to a potential for visible particulates.
The Medicines Company has not received any reports of adverse events related to this issue. However, due to the possible presence of visible particulates there is a risk of embolization/infarction to organs with potential organ complications.
Whole Foods Market issues allergy alert for undeclared walnuts in Mini Chocolate Chip Cookies
Whole Foods Market is recalling Mini Chocolate Chip Cookies because the product has undeclared walnuts. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reaction if they consume the product