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- FDA Alerts
- Recalls (Drug & Food)
Aron Streit, Inc. Issues Allergy Alert On Undeclared Milk Allergens In "Streit's Dark Chocolate Coi...Jan 29, 2015 - Aron Streit, Inc. of New York, NY is recalling its .5 ounce packages of "Streit's Dark Chocolate Coins" because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if they consume this product.Aleias Gluten Free Foods, LLC Issues Allergy Alert on Undeclared Peanut Protein in Parmesan Crouton...Jan 29, 2015 - Aleias Gluten Free Foods, LLC has issued a voluntary and precautionary recall of certain lots of its 8 ounce Parmesan Croutons and Classic Croutons because they may contain undeclared peanut protein. People who have an allergy to peanuts run the risk of a serious or life-threatening allergic reaction if they consume these products.Jan 29, 2015 - Arcadia Trading Inc. of Brooklyn, N.Y. is recalling all packages of Red Thread Fish because they are uneviscerated. The product comes in a 7 oz. heat sealed plastic bag.Jan 27, 2015 - Elevated Ice Cream Co. advises our customers that our dairy, Snoqualmie Gourmet Ice Cream Dairy in Maltby, has issued a voluntary recall of all dairy products processed in their plant. Elevated Ice Cream uses dairy products processed by Snoqualmie Gourmet, therefore we are asking all of our customers not to eat any ice cream which may be in your home freezers.Jan 27, 2015 - Lime Green Grocer, Inc. of Seattle, Washington is recalling 783 individually wrapped Thai Delight Burritos, because it may contain undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product.Probar LLC Recalls Probar Base Frosted Peanut Butter Bars Due to Possible Presence of Undeclared Mi...Jan 27, 2015 - PROBAR LLC of Salt Lake City, UT has initiated a voluntary recall of its PROBAR Base Frosted Peanut Butter Bars due to the possible presence of an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of a serious allergic reaction if they consume this product. No other PROBAR products are affected.Comunicado Actualizado: Quesera Bendita LLC Retira Quesos Frescos Y Crema Agria Debido a Posibles R...Jan 26, 2015 - Quesería Bendita LLC, de Yakima, Washington, está retirando todos los lotes de productos de queso panela, queso fresco, requesón, queso Cotija y crema agria que incluyen TODAS las fechas de caducidad debido a la posibilidad de que estén contaminados con la bacteria Listeria monocytogenes, un organismo que puede causar infecciones graves y a veces hasta mortales en infantes, personas mayores o con una salud delicada y otras personas con un sistema inmunológico debilitado. Aunque las personas sanas quizás sólo sufran síntomas a corto plazo, tales como fiebre alta, dolor de cabeza intenso, rigidez, náuseas, dolor abdominal y diarrea, la infección por listeria puede causar abortos y mortinatos (nacimiento muerto del bebé) entre las mujeres embarazadas.Jan 26, 2015 - Korean Food Co. in Irving, Texas is recalling Mak kimchi in 32oz and half gallon glass jars, because it may contain undeclared shellfish (shrimp). People who have an allergy or severe sensitivity to shellfish (shrimp) run the risk of serious or life-threatening allergic reaction if they consume these products.Jan 23, 2015 - J.J. Fuds in Valparaiso, IN is recalling a select lot and product of J.J. Fuds Chicken Tender Chunks Pet Food 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.Jan 23, 2015 - Cox Veterinary Laboratory, Inc. is voluntarily recalling the lots of Gastroade Xtra identified below down to the consumer level distributed nationwide. Gastroade Xtra was previously marketed by Cox Veterinary Laboratory as an OTC drug for use in horses, and contains Omeprazole.Hospira Issues a Voluntary Nationwide Recall of One Lot of 0.9% Sodium Chloride Injection, USP, 250...Jan 23, 2015 - Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL (NDC 0409-7983-02, Lot 44-002-JT, Expiry 1AUG2016) to the user level due to one confirmed customer report of particulate in a single unit. Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.Jan 22, 2015 - Freeland Foods, Inc. of San Jose, CA is voluntarily recalling the Go Raw Organic Spicy Seed Mix, because it has the potential to be contaminated with Salmonella, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems.Gonnella Baking Company Issues Allergy Alert on Undeclared Milk in Jewel Brand Gourmet Sandwich Rol...Jan 22, 2015 - Gonnella Baking Company (GBC) of Schaumburg, Illinois is voluntarily recalling 20 oz. packages of Jewel brand Gourmet Sandwich Rolls (Product Code 11563) and 20 oz. packages of Gonnella brand Sub Buns (Product Code 15840) due to undeclared milk. Whey, which is derived from milk, is not listed as an ingredient on the labels.Jan 21, 2015 - Tarrier Foods of Columbus, OH is recalling 316 cases of Chopped Twix item 0807, because it may contain undeclared peanuts and eggs. People who have an allergy or severe sensitivity to peanuts and eggs run the risk of serious or life-threatening allergic reaction if they consume this product.Jan 20, 2015 - Northern Tier Bakery LLC of St. Paul Park, MN is voluntarily recalling Twix Bismarck doughnuts due to the possibility of an undeclared peanut allergen in the Twix topping sourced from a third party.Inventure Foods, Inc. Issues Voluntary Recall Of Its Rader Farms Fresh Start Smoothie Blend, Sunris...Jan 18, 2015 - Inventure Foods, Inc. of Phoenix, Arizona, has issued a precautionary recall of its RADER FARMS Fresh Start Smoothie Blend, Fresh Start Sunrise Refresh Fusion, and Fresh Start Daily Power Fusion because of a 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.Jan 16, 2015 - Queseria Bendita LLC of Yakima, Washington is recalling all lots of Panela, Queso Fresco, Requeson, Cotija fresh soft cheese products and Sour Cream to include those with best by dates up to 4/16/2015 because of a 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.Jan 16, 2015 - Oma's Pride of Avon, CT is recalling Purr-Complete Feline Poultry Meal because it has the potential to be contaminated with Salmonella.Ã‚Â Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.B&M, Inc. Issues Allergy Allert on Undeclared Peanut Protein in Ground Cumin and Other Seasonings S...Jan 16, 2015 - B&M, Inc. of Mount Vernon, Missouri is recalling certain seasoning blends that contain ground cumin that may contain peanut, an allergen that is not declared on the products’ ingredient statements. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.B&M, Inc. Issues Allergy Alert on Undeclared Peanut Protein in Ground Seasonings Sold at Harris Tee...Jan 16, 2015 - B&M, Inc. of Mount Vernon, Missouri is recalling certain seasoning blends that contain ground cumin that may contain undeclared peanut protein, an allergen that is not declared on the product’s ingredient statements. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.
- Consumer Health Info
Jan 27, 2015 - Scientists are working to develop breakthrough therapies for pancreatic cancer, one of the deadliest cancers that affects both men and women. FDA has approved three treatments for advanced pancreatic cancer to help patients live longer.Jan 15, 2015 - Have an overactive bladder? FDA-approved treatments can help adults of any age control their symptoms and live an active life.Jan 5, 2015 - Many so-called miracle weight loss supplements and foods (including teas and coffees) don't live up to their claims. Worse, they can cause serious harm.Dec 23, 2014 - In much of the Northern Hemisphere, this is prime time for colds, influenza (flu), and other respiratory illnesses. While contagious viruses are active year-round, fall and winter are when we're all most vulnerable to them.Dec 19, 2014 - When operated unsafely, or without certain controls, the highly-concentrated light from lasersâ€”even those in toysâ€”can be dangerous, causing serious eye injuries and even blindness. FDA has issued draft guidance on the safety of toy laser products to protect children from harm.Dec 17, 2014 - Got questions about the foods, drugs and other issues involving your pet? FDA's Center for Veterinary Medicine (CVM) may be able to answer them. Read these seven frequently asked questions, and CVM's answers.Dec 16, 2014 - FDA officials are concerned over the marketing of fetal keepsake videos and over-the-counter Doppler ultrasound heartbeat monitors.Dec 12, 2014 - FDA warns consumers about an undeclared ingredient in a coffee drink, a risk of infection from a children’s supplement, and a sexual enhancement product that contains the active ingredient found in Viagra.Dec 3, 2014 - The Food and Drug Administration is helping women and their health care providers to learn more about the effects of medicines during pregnancy and breastfeeding.Dec 3, 2014 - Pregnant women who are prescribed a drug may worry of the potential impact on their developing fetuses. FDAÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s pregnancy registries can help ease that worry.Dec 2, 2014 - FDA is working hard to make sure you have the information you need to make informed decisions about your health.Dec 1, 2014 - Continuous glucose monitoring technology alerts patients to low and high blood sugar levels, including how quickly they are changing.Nov 17, 2014 - Sometimes a cold is just a cold. What can worried parents do when their babies and young children have a cold? FDA has some advice and tips.Nov 14, 2014 - FDA warns consumers about baby wipes that may contain bacteria, undeclared drugs found in a product sold as a dietary supplement with weight loss claims, and a pain reliever packaging mix up.Nov 14, 2014 - To implement the section of the Affordable Care Act related to nutrition labeling, FDA is publishing final rules that require calorie information to be listed on menus and menu boards, and near self-serve foods and foods on display in certain chain restaurants, food stores, entertainment venues, and vending machines. The goal is to help consumers make more informed choices about what they eat away from home.Nov 12, 2014 - Food and Drug Administration analysts and entomologists investigate product samples and protect consumers from spoiled and contaminated food.Nov 5, 2014 - This guide provides tips and a quick-reference chart to help you report a problem to FDA.Nov 3, 2014 - If you eat meat or drink milk, you want to know: Are the veterinary drugs used in food-producing animals entering your diet? And if they are, are the amounts safe for human consumption? Those are some of the concerns of FDA's Division of Residue Chemistry.Oct 31, 2014 - Got a question about a medicine? FDA's Division of Drug Information can answer it.Oct 29, 2014 - Mammograms are still the best tool for breast cancer screening. As we observe Breast Cancer Awareness Month this October, learn how FDA certifies facilities that perform mammographyÃ¢â‚¬â€�and, clears and approves mammography devicesÃ¢â‚¬â€�to help keep you safe.
- News Releases
Jan 29, 2015 - The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for previously treated patients with Waldenström’s macroglobulinemia (WM), a rare form of cancer that begins in the body’s immune system. The drug received a breakthrough therapy designation for this use.Jan 28, 2015 - The U.S. Food and Drug Administration announced today that it will strengthen its review of automated external defibrillators (AEDs) to help improve the quality and reliability of these devices.Jan 26, 2015 - The U.S. Food and Drug Administration today approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach.Jan 26, 2015 - U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D., today appointed Robert Califf, M.D., a recognized global leader in cardiology, clinical research, and medical economics, as FDA Deputy Commissioner for Medical Products and Tobacco.Jan 23, 2015 - The U.S. Food and Drug Administration today approved Natpara (parathyroid horomone) to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 people in the United States.Jan 23, 2015 - The U.S. Food and Drug Administration today approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.Jan 23, 2015 - The U.S. Food and Drug Administration today allowed marketing of the first set of mobile medical apps that allow people with diabetes to automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time using an Apple mobile device such as an iPhone.Jan 23, 2015 - Today, the U.S. District Court of the Eastern District of Missouri sentenced Sabahhadin Akman, an owner of the Turkish firm Ozay Pharmaceuticals, to 30 months imprisonment and a $150,000 fine for smuggling counterfeit, misbranded and adulterated cancer treatment drugs into the U.S., including multiple shipments of Altuzan, the Turkish version of Avastin.Jan 21, 2015 - The U.S. Food and Drug Administration today approved Cosentyx (secukinumab) to treat adults with moderate-to-severe plaque psoriasis.Jan 16, 2015 - A California dietary supplement manufacturer was ordered by a federal court to stop selling its products until the company comes into compliance with the U.S. Food and Drug Administration’s dietary supplement manufacturing regulations and other requirements listed in the consent decree.Jan 14, 2015 - The U.S. Food and Drug Administration today approved the Maestro Rechargeable System for certain obese adults, the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness.Jan 8, 2015 - The U.S. Food and Drug Administration today approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.Jan 6, 2015 - The U.S. Food and Drug Administration today granted the first waiver to allow a nucleic acid-based test, the Alere i Influenza A & B test, to be used in a greater variety of health care settings. The test was previously only available for use in certain laboratories.Dec 23, 2014 - The U.S. Food and Drug Administration today approved Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.FDA Commissioner Margaret A. Hamburg's statement on FDAs blood donor deferral policy for men who ha...Dec 23, 2014 - The U.S. Food and Drug Administration is a science-based regulatory agency that works to protect and promote the public health. In this role, it is our responsibility to regulate the blood supply and to help ensure its continued safety for the patients who receive these life-saving products.Dec 22, 2014 - The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs.Dec 22, 2014 - On December 19, the U.S. Food and Drug Administration approved Rapivab (peramivir) to treat influenza infection in adults.Dec 19, 2014 - The U.S. Food and Drug Administration today approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).Dec 19, 2014 - The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.Dec 19, 2014 - The U.S. Food and Drug Administration today granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.