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- FDA Alerts
- Recalls (Drug & Food)
Boulder Dog Food Company, L.L.C. Voluntarily Recalls Seven Bags of Turkey Sprinkles, 3 oz with A Be...Jul 2, 2015 - Boulder Dog Food Company, L.L.C. is voluntarily recalling the Turkey Sprinkles (3 oz.) with a “Best By” date of “05/18/16, 05/28/2016 and 05/30/2016”, a Lot Number of “743”, and a UPC Code of 899883001224 because the product has the potential of being contaminated with Salmonella. Salmonella can affect animals eating the product, and there is risk to humans who handle the product, especially if the handler does not thoroughly wash his or her hands after having contact with the Product or any surfaces exposed to the product.Whole Foods Market's Southwest Region Recalls Cherry, Blackberry and Peach Pies in Four Stores Due ...Jul 2, 2015 - Whole Foods Market is recalling Cherry, Blackberry and Peach pies produced and sold in four retail stores in the Southwest Region, which includes TX, OK, LA, and due to undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products.Jul 1, 2015 - Vitamin Cottage Natural Food Markets Inc., a Lakewood, Colo., based natural grocery chain, is recalling one lot of Natural Grocers brand Caribbean Nut & Fruit Mix as the product contains macadamia nuts that 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.Jun 29, 2015 - Atkins Nutritionals, Inc. is initiating a voluntary recall of a limited quantity of Atkins Chocolate Candies – 5 ct. cartons - UPC code 637480075558 – because it may contain sachets of Atkins Peanut Candies. A small quantity of Atkins Peanut Candy individual sachets has been inadvertently placed into outer cartons for Atkins Chocolate Candies – 5 ct. sachets.Rocky Mountain Foods, Inc. Voluntarily Recalls Free Range Snack Co. Brand 16 oz. Island Fruit and N...Jun 29, 2015 - Rocky Mountain Foods, Inc. is voluntarily recalling certain lots of Island Fruit and Nut Trail Mix packaged under the Free Range Snack Co. Brand and certain lots of bulk Macadamia Nuts due to possible Salmonella contamination. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.Jun 27, 2015 - GRAND BK CORP. of MASPETH, NEW YORK is recalling 450 CASES OF GOODIES CASHEW RAW 9OZ, 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.H-E-B Issues Voluntary Recall H-E-B hamburger and hotdog buns and Hill Country Fare hotdog buns rec...Jun 26, 2015 - H-E-B, committed to the quality of its products, is issuing a voluntary recall for H-E-B brand hamburger and hotdog buns and Hill Country Fare hotdog buns due to the possible presence of foreign material that might impact the quality of the product. A terry cloth glove used for handling hot pans could have broken up in the dough, resulting in a potential choking hazard.Jun 26, 2015 - Whole Foods Market is voluntarily recalling packaged raw macadamia nuts due to possible Salmonella contamination. Salmonella is 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.Wish-Bone Salad Dressing Issues Allergy Alert on Undeclared Egg in 24 oz. Wish-Bone Ranch Salad Dre...Jun 23, 2015 - Pinnacle Foods Group LLC is voluntarily recalling a limited quantity of its Wish-Bone Ranch Salad Dressing variety, due to the product containing Wish-Bone Blue Cheese Dressing, inadvertently packed in Ranch Salad Dressing bottles and was brought to our attention by a consumer. This product contains eggs, a known allergen not declared on the packaging.Medtronic Implements Worldwide Voluntary Recall for Certain Lots of Neonatal and Pediatric Tracheos...Jun 23, 2015 - Medtronic (NYSE: MDT) announced that on May 8, 2015, it began notifying hospitals and distributors worldwide that affected lots of its Covidien Shiley(TM) tracheostomy tubes were formed with a wider-angle bend than standard models manufactured after November 29, 2012. The company initiated the field action following a small number of customer complaints that included reports of 12 serious patient injuries, such as breathing difficulties that impacted oxygen levels immediately upon tube placement or discomfort.Jun 23, 2015 - La Mexicana Food Products of Vernon, CA is recalling Spinach Dip because product labels failed to declare the food allergen, Milk, as a sub-ingredient of the listed ingredient, Sour Cream. People who have an allergy or severe sensitivity to Milk run the risk of a life threatening allergic reaction, anaphylaxis, that requires immediate medical attention should they consume products containing allergens.Jun 23, 2015 - Good Seed Inc. of Springfield, VA is voluntarily recalling all packages of soybean sprouts and mung bean sprouts because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals 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.Jun 22, 2015 - Project 7 is voluntarily recalling all lots distributed of Sour Caramel Apple Gum from August 20th, 2014 to June 11th, 2015 because the caramel flavoring ingredient in the gum contains a small amount of dairy, an allergen that is not declared on the packaging. People who have an allergy to milk run the risk of experiencing a serious or lifeÃ¢â‚¬ï¿½threatening reaction if they consume the product.Jun 19, 2015 - United Salad Co., the distributor of Portland, Oregon, is initiating a voluntary recall of Champ's Sliced Crimini Mushrooms, product of Canada, 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.Boulder Dog Food Company, L.L.C. Voluntarily Recalls Ten Bags of Chicken Sprinkles, 3 oz. With A Be...Jun 19, 2015 - Boulder Dog Food Company, L.L.C. is voluntarily recalling the Chicken Sprinkles (3 oz.) with a “Best By” date of “05/04/16”, a Lot Number of “998”, and a UPC Code of 899883001231 (the “Product”), because the Product has the potential of being contaminated with Salmonella. Salmonella can affect animals eating the Product, and there is risk to humans who handle the Product, especially if the handler does not thoroughly wash his or her hands after having contact with the Product or any surfaces exposed to the Product.The Raymond-Hadley Corporation Issues Allergy Alert on Undeclared Sulfites in Phoebe Mote Blanco Wh...Jun 18, 2015 - The Raymond-Hadley Corporation, 89 Tompkins Street, Spencer, NY 14883 is recalling PHOEBE MOTE BLANCO WHITE CORN SEMOULE DE MAIS BLANC, PESO NETO 396.9 g, NET WEIGHT 14oz. PHOEBE MOTE PELADO BLANCO 50lb. PHOEBE MOTE PELADO BLANCO PESO NETO 1530g, NET WEIGHT 54oz. PHOEBE MOTE BLANCO PEELED WHITE CORN PESO NETO 1814g, NET WEIGHT 4lb. because it may contain undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.G&C Natural Nutrition, Inc. Issues Voluntary Nationwide Recall of Pyrola Due to Undeclared Drug Ing...Jun 13, 2015 - G&C Natural Nutrition, Inc. is voluntarily recalling all lots of Pyrola, 430mg/capsule. Advanced Joint Formula capsules may contain undeclared diclofenac and chlorpheniramine.Philips Response To ResMed Update On Phase IV SERVE-HF Study Of Adaptive Servo-Ventilation (ASV) Th...Jun 11, 2015 - On May 15, 2015, Respironics, Inc., a Philips business, provided the following response to ResMed’s Update on Phase IV SERVE-HF Study of Adaptive Servo-Ventilation (ASV) Therapy in Central Sleep Apnea and Chronic Heart Failure. On May 13, 2015, ResMed issued a press release and a related Urgent Field Safety Notice.Wisconsin Firm Voluntarily Recalls Potato Salad Due to the Possible Presence of Listeria Monocytog...Jun 11, 2015 - A Wisconsin firm is voluntarily recalling its potato salad, due to the possibility of Listeria monocytogenes contamination. The product was distributed to Jewel stores in the Chicago area and may have been sold at delicatessen counters between May 30 and June 9 under the brand name Garden Fresh Steakhouse Potato Salad.Jun 10, 2015 - Vitamin Cottage Natural Food Markets Inc., a Lakewood, Colo., based natural grocery chain, is recalling additional lots of Natural Grocers brand Macadamia Nuts as the product 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.
- Consumer Health Info
Jul 1, 2015 - FDA is taking action against 16 prescription drugs labeled to relieve ear pain and swelling because they are unapproved and haven't been evaluated by FDA for safety, effectiveness and quality. Parents and other consumers still will have many other options for treating ear pain.Jun 25, 2015 - FDA is warning consumers about problems with mammograms at Coastal Diagnostic Center, Calif., and illegal Ebola Virus Test Kits.Jun 23, 2015 - Results of the National Youth Tobacco Survey provide a snapshot of tobacco products used by today's youth and reveal some surprising new trends.Jun 16, 2015 - FDA is taking action which will significantly reduce harmful trans fat in the U.S. food supply.Jun 8, 2015 - Occasionally pet foods and treats can be contaminated with harmful bacteria and can make pets, and sometimes owners, sick. FDA is studying this issue to help keep you and your four-legged friends safeJun 3, 2015 - Don't let expired or unused medicines collect in your home. Learn about community take-back programs, including the annual National Prescription Drug Take Back Day, and other ways to dispose of unused drugs safely.May 21, 2015 - FDA is releasing more information about its study finding that some dark chocolate products contain varying amounts of milk. And you can't always tell that's the case simply by reading the food label.May 13, 2015 - FDA reviews a study about a psychiatric drug, and warns consumers about mislabeled over-the-counter medicine, certain human and veterinary drugs, certain homeopathic products, and mammograms performed at a medical practice in North Carolina.May 8, 2015 - MotherÃ¢â‚¬â„¢s Day is May 11, an exciting time for new moms. But moms (and dads) of babies 12 months and younger can also have some worries. FDA medical officers offer health suggestionsApr 22, 2015 - FDA warns consumers about unapproved drugs in a weight loss pill, risk of side effects from a psychiatric drug, and an undeclared drug in a herbal supplement.Apr 20, 2015 - Colorectal cancer is preventable and, if caught early enough, treatable. FDA explains who should get screened and when.Apr 8, 2015 - The Food and Drug Administrationâ€™s Office of Communications has concluded a Memorandum of Understanding with Healthline.com, which has agreed, a.o., to post FDA Consumer Updates and other content on its website, produce a newsletter and alerts that feature FDA content, and provide direct links back to FDA web content such as the agencyâ€™s RSS feed for product recalls.Mar 23, 2015 - FDA recommends manufacturers stop using "latex-free" label because all products contain some natural rubber latex proteins.Mar 23, 2015 - FDA continues to warn companies when they make drug claims about cosmetic products that have not been approved by the agency.Mar 6, 2015 - The Food and Drug Administration (FDA) is approving Zarxio (filgrastim-sndz), the first biosimilar product (or biosimilar), and expects to approve others in the months ahead. What are biosimilars? How will they affect patient treatment?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.
- News Releases
Jul 2, 2015 - The U.S. Food and Drug Administration today approved the first drug for cystic fibrosis directed at treating the cause of the disease in people who have two copies of a specific mutation.Jul 1, 2015 - A federal judge for the District of New Jersey has entered a consent decree of permanent injunction between the United States and Acino Products LLC (Acino), of Hamilton, New Jersey, and the company’s president, Ravi Deshpande, for marketing unapproved and misbranded prescription drugs.Jul 1, 2015 - The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation.Jun 26, 2015 - Today, the U.S. District Court of the District of New Jersey sentenced the OtisMed Corporation’s (OtisMed) former chief executive officer, Charlie Chi, to 24 months in prison and also ordered him to serve one year of supervised release and to pay a $75,000 fine.Jun 22, 2015 - The U.S. Food and Drug Administration today approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. It is approved for adult patients undergoing percutaneous coronary intervention (PCI), a procedure used to open a blocked or narrowed coronary artery to improve blood flow to the heart muscle.Jun 18, 2015 - The Food and Drug Administration today allowed marketing of a new device that when used along with other assistive devices, like a cane or guide dog, can help orient people who are blind by helping them process visual images with their tongues.FDA takes action to protect consumers from potentially dangerous counterfeit medicines and devices ...Jun 18, 2015 - The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 1,050 websites that illegally sell potentially dangerous, unapproved prescription medicines and medical devices to consumers. These actions include the issuance of regulatory warnings to the operators of offending websites and seizure of $81 million worth of illegal medicines and medical devices worldwide.Jun 17, 2015 - The U.S. Food and Drug Administration today approved the SAPIEN 3 Transcatheter Heart Valve (THV) for patients with a narrowing in the heart's aortic valve, called aortic valve stenosis. Aortic valve stenosis obstructs blood flow from the heart into the aorta, which can lead to serious heart problems. The SAPIEN 3 THV is approved for patients with aortic valve stenosis who are inoperable or at high risk for death or complications associated with open-heart surgery.Jun 16, 2015 - Based on a thorough review of the scientific evidence, the U.S. Food and Drug Administration today finalized its determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. Food manufacturers will have three years to remove PHOs from products.Jun 12, 2015 - The U.S. Food and Drug Administration today approved the Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson’s disease and essential tremor, a movement disorder that is one of the most common causes of tremors. The Brio Neurostimulation System can help some patients when medication alone may not provide adequate relief from symptoms such as walking difficulties, balance problems, and tremors.Jun 2, 2015 - The U.S. Food and Drug Administration announced today the Veterinary Feed Directive (VFD) final rule, an important piece of the agency’s overall strategy to promote the judicious use of antimicrobials in food-producing animals. This strategy will bring the use of these drugs under veterinary supervision so that they are used only when necessary for assuring animal health. The VFD final rule outlines the process for authorizing use of VFD drugs (animal drugs intended for use in or on animal feed that require the supervision of a licensed veterinarian) and provides veterinarians in all states with a framework for authorizing the use of medically important antimicrobials in feed when needed for specific animal health purposes.May 28, 2015 - The U.S. Food and Drug Administration today approved Rapamune (sirolimus), to treat lymphangioleiomyomatosis (LAM), a rare, progressive lung disease that primarily affects women of childbearing age. This is the first drug approved to treat the disease.May 27, 2015 - The U.S. Food and Drug Administration today approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.May 19, 2015 - The U.S. Food and Drug Administration proposed a rule today that would require animal drug sponsors of all antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales by major food-producing species (cattle, swine, chickens and turkeys). The additional data would improve understanding of how antimicrobials are sold or distributed for use in major food-producing animals and help the FDA further target its efforts to ensure judicious use of medically important antimicrobials.May 18, 2015 - As part of its overall efforts to address compounded drugs, the U.S. Food and Drug Administration today released a draft “Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances.”May 8, 2015 - Today the U.S. Food and Drug Administration approved the Senza spinal cord stimulation (SCS) system (Senza System) as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain. The Senza System can reduce pain without producing a tingling sensation called paresthesia by providing high frequency stimulation (at 10 KHz) and low stimulation amplitudes.May 8, 2015 - The U.S. Food and Drug Administration today approved Avelox (moxifloxacin) to treat patients with plague, a rare and potentially fatal bacterial infection. The agency approval for plague includes use of the drug for the treatment of pneumonic plague (infection of the lungs), and septicemic plague (infection of the blood). Avelox is also approved for prevention of plague in adult patients.