The U.S. Food and Drug Administration today approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children older than 6 years who have had inadequate response to conventional therapy.
FDA approves Soliris for rare pediatric blood disorder
The U.S. Food and Drug Administration today approved Soliris (eculizumab) to treat patients with atypical Hemolytic Uremic Syndrome (aHUS), a rare and chronic blood disease that can lead to kidney (renal) failure and is also associated with increased risk of death and stroke.
FDA: Over-the-counter asthma inhalers containing chloroflouorocarbons (CFCs) will no longer be made or sold after Dec. 31, 2011
The U.S. Food and Drug Administration says users of epinephrine inhalers containing chlorofluorocarbons (CFCs) should plan now to get a prescription for a replacement product because these inhalers will not be made or sold after Dec. 31, 2011.
FDA confirms Listeria monocytogenes on Jensen Farms’ Rocky Ford-brand cantaloupes
Today, the Food and Drug Administration announced that it found Listeria monocytogenes in samples of Jensen Farms’ Rocky Ford-brand cantaloupe taken from a Denver-area store and on samples taken from equipment and cantaloupe at the Jensen Farms’ packing facility. Tests confirmed that the Listeria monocytogenes found in the samples matches one of the three different strains of Listeria monocytogenes associated with the multi-state outbreak of listeriosis.
DEL BUENO RETIRA QUESO CON POSIBILIDAD DE RIESGO DE SALUD
Del Bueno de Grandview, WA esta retirando tamiaño de 16oz. paquetes de Queso Fresco Casero porque tienen el potencial de estar contaminados con Listeria monocytogenes, un organismo que causa serios y a veces fatales infecciones en niños pequeños, ancianos, y otros con sistemas inmunes débiles . Aunque personas saludables pueden sufrir solamente un corto plazo de síntomas como fiebre, severo dolor de cabeza, rigidez, nausea, dolor abdominal y diarrea, la infección de Listeria puede causar aborto involuntario y muerte fetal en mujeres embarazadas
Del Bueno Recalls Queso Fresco Casero Cheese Because of Possible Health Risk
Del Bueno of Grandview, WA is recalling all 16oz. size packages of Queso Fresco Casero Fresh Cheese with a date stamp of Sept 14, 2011 because it 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.
Qualitest Pharmaceuticals Issues a Nationwide Voluntary Recall of Oral Contraceptives
Qualitest Pharmaceuticals today issued a voluntary, nationwide, retail-level recall of multiple lots of oral contraceptives. The recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible.
FDA Drug Safety Podcast for Healthcare Professionals: Abnormal heart rhythms may be associated with use of Zofran (ondansetron)
On September 15, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public of an ongoing safety review of the anti-nausea drug Zofran, active ingredient ondansetron, ondansetron hydrochloride and their generics.
Strong America Ltd Issues Alert on Undeclared Sulfites in Huipu Chinese Wolfberry
Strong America Ltd, NY is recalling its 5.28 ounce packages for Huipu Chinese Wolfberry because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of the serious or life-threatening allergic reactions if they consume this product.
FDA establishes foodborne illness outbreak response network
The U.S. Food and Drug Administration (FDA) announced today a streamlined, integrated approach to effectively and rapidly respond to human and animal foodborne illness outbreaks: the FDA Coordinated Outbreak Response and Evaluation (CORE) Network.