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).
Category Archives: Food & Drug Recalls
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.
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
Thoratec Corporation Issues Update on Worldwide Medical Device Correction Notification Relating to Sealed Outflow Graft Used With HeartMate II Left Ventricular Assist System
On February 23 2012 Thoratec Corporation initiated a voluntary worldwide medical device correction notification of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalog No. 104692 103393 104911 or 104912
FDA approves LINX Reflux Management System to treat gastroesophageal reflux disease
The Food and Drug Administration today approved the LINX Reflux Management System for people diagnosed with gastroesophageal reflux disease (GERD) who continue to have chronic symptoms, despite the use of maximum medical therapy for the treatment of reflux.
FDA approves first Boniva generics to treat or prevent osteoporosis
The U.S. Food and Drug Administration today approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause.
El Ranchero Del Sur, LLC Recalls El Ranchero Queso Fresco (Fresh Cheese), Los Corrales Queso Fresco en Hoja de Platano (Fresh Cheese in Banana Leaf), and El Ranchero Queso Oaxaca (String Cheese) Because of Possible Health Risk
El Ranchero Del Sur, LLC. of South River, New Jersey is recalling El Ranchero Queso Fresco 14 oz. (Fresh Cheese), Los Corrales Queso Fresco en Hoja De Platano 14 oz. (Fresh Cheese In Banana Leaf), El Ranchero Queso Oaxaca 14 oz. and 10 lb. (String Cheese) because they have 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.
Troyer Cheese, Inc. Recalls Backroad Country Caramel Puffcorn Sold in 8oz and 16oz Plastic Bags Because of Undeclared Milk
Troyer Cheese, Inc. is recalling specific expiration dates of their Backroad Country Caramel Puffcorn sold in 8 and 16 ounce plastic bags because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products.