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- FDA Alerts
Dec 31, 2010 - The FDA has issued updated information on atypical fractures of the femur associated with the use of bisphosphonates to treat osteoporosis. These drugs include Fosamax (alendronate sodium), Actonel (risedronate sodium), Boniva (ibandronate sodium), ...Dec 31, 2010 - Actavis is recalling certain lots of the company's fentanyl transdermal patches because they may release the active ingredient faster than they should. An accelerated release of fentanyl, a strong opioid narcotic, could lead to adverse events such a...Dec 31, 2010 - FDA is informing oncologists that recent changes in how serum creatinine is measured could lead to the wrong carboplatin dose. All clinical labs in the U.S. will soon be using a newly standardized method to measure serum creatinine -- Isotope Di...Dec 31, 2010 - The FDA has issued an update on its continuing investigation of excessive radiation exposure from CT brain perfusion scans, including expanded recommendations for radiology personnel performing these procedures. FDA is now aware of 385 patients ...Dec 31, 2010 - The labeling for Gonadotropin-Releasing Hormone (GnRH) agonists is being updated to describe an increased risk of diabetes and certain cardiovascular diseases in patients being treated for prostate cancer. GnRH agonists are sold under a variety of b...Dec 31, 2010 - FDA is notifying healthcare professionals about updated pediatric dosing recommendations for Valcyte oral tablets and solution. Valcyte is an antiviral medication used to prevent cytomegalovirus (CMV) disease in pediatric patients who have undergone ...Dec 31, 2010 - An FDA article in the journal Nursing2009 describes problems that can arise with the use alarms on patient monitoring equipment. From 2005 through 2008, FDA received 566 reports of patient deaths related to the alarms on monitoring devices. Part of ...Dec 31, 2010 - Resectoscopes are devices used to remove tissue during endoscopy procedures. Unless they are assembled properly before each procedure, these devices can fail. For example, FDA has a report about a 2-month-old infant undergoing cystoscopy to incise ...Dec 31, 2010 - FDA is warning people not to use Hyland's Teething Tablets because they may pose a risk to babies and children. The product, which is being recalled by the manufacturer, is intended to temporarily relieve a child's teething symptoms. Hyland's Te...
- Recalls (Drug & Food)
Apr 17, 2014 - Price Chopper Supermarkets is issuing a voluntary recall on its Price Chopper Brand Tuscan White Bean Hummus. The product is being recalled due to it being mislabeled with the ingredient panel for Price Chopper Sweet Potato Hummus, which does not declare that the product contains parmesan cheese, a known allergen.Natural Organics, Inc. Recalls one lot ofTHURSDAY PLANTATION TEA TREE MOUTHWASH Due to Bacterial Co...Apr 16, 2014 - Natural Organics, Inc. is expanding its April 3, 2014 recall of distributed Thursday Plantation Tea Tree Mouthwash to Lot 10952 after they were notified by its contract manufacturer INTEGRIA Healthcare (Australia} Pty Ltd. that this second lot of Tea Tree Mouthwash failed microbial contamination testing due to potential bacterial contamination. This bacterial contaminant, Pseudomonas aeruginosa, could pose a health risk to consumers.Health Matters America Inc. Issues Allergy Alert on Undeclared Milk in Organic Traditions Brand Dar...Apr 16, 2014 - HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is recalling specific lots of ORGANIC TRADITIONS BRAND DARK CHOCOLATE GOLDEN BERRIES AND DARK CHOCOLATE SACHA INCHI SEEDS because they were found to contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume these products.Apr 16, 2014 - The Purina Animal Nutrition LLC feed plant in Portland, Ore., has initiated a limited recall of certain poultry feeds due to the potential for lower-than-expected vitamin and trace mineral levels. The products were distributed to retailers in Oregon and Washington.Apr 14, 2014 - The Kroger Co. (NYSE: KR) said today it has recalled Private Selection Sweet Strawberry Sorbet sold at the company’s Kroger and Jay C stores in 13 states because the product may contain milk not listed on the label. People who are allergic to milk could have a severe reaction if they consume this product.La Compaa Fernndez Chile Inc. retira del mercado Chile Molido Puro de 4 onzas y Chile Rojo de 6 on...Apr 11, 2014 - La Compañía Fernández Chile Inc. de Alamosa , Colorado está retirando del mercado su Chile Molido Puro de 4 onzas (oz) código de barras UPC 77601- 10011 y Chile Rojo de 6 onzas (oz) con código de barra UPC 77601-10053, ya que pueden estar potencialmente contaminados con Salmonella, un organismo que puede causar infecciones serias y a veces fatales en los jóvenes, personas débiles o ancianas , y con sistemas inmunológicos debilitados.Sinco Inc Issues Allergy alert on undeclared Peanut Protein in Archer Farms Chocolate Hazelnut Swir...Apr 11, 2014 - SINCO INC is voluntarily recalling from sale Archer Farms Chocolate Hazelnut Swirl Gelato 30 FL OZ (UPC 085239-703618), imported from Italy and sold exclusively at Target stores nationwide. This product may contain traces of peanut protein, which is not declared on the label.Apr 11, 2014 - Covidien plc today announced that it has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline™ Embolization Device and Alligator™ Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices.Fernandez Chile Company Inc. Recalls 4oz Chile Molido Puro and 6oz Chile Rojo Potential Salmonella ...Apr 10, 2014 - Fernandez Chile Company Inc of Alamosa, Colorado is recalling 4oz Chile Molido Puro UPC code 77601-10011 and 6oz Chile Rojo UPC code 77601-10053 because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.Apr 10, 2014 - Karl Bissinger’s LLC today announced a recall of its Dark Chocolate Bunny Ears because one lot was mislabeled and contains undeclared milk. People who have a severe sensitivity to milk run the risk of a serious or life threatening reaction if they consume this product.Apr 10, 2014 - Swanson Health Products is voluntarily recalling Swanson Premium Brand Full Spectrum Cilantro (Coriander), item number SW1112, because it has the potential to be contaminated with salmonella.Lisy Corporation Issues Recall on: Lisy Sweet Basil (Albahaca) 6 Oz., Item 1132 Lot #'s A013 0518 &...Apr 9, 2014 - Lisy Corporation of Miami, FL is voluntarily recalling Lisy Sweet Basil (Albahaca), 6 oz jar, Item #1132, Lot #’s A013 0518 & A014 0518, because it has the potential to be contaminated with Salmonella. 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.The Robert Abady Dog Food Co., LLC Recalls "Abady Highest Quality Maintenance & Growth Formula for ...Apr 9, 2014 - The Robert Abady Dog Food Co., LLC of Poughkeepsie, NY, is recalling its 2 lb, 5 lb & 15 lb boxes of "Abady Highest Quality Maintenance & Growth Formula for Cats" 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.Apr 9, 2014 - Frontier Natural Products Co-op is voluntarily recalling several of its products manufactured with organic black peppercorns that were sold under its Frontier and Simply Organic brands, Whole Foods Market 365 Everyday Value, Nature’s Place and others due to potential Salmonella contamination. To date, no illnesses have been associated with these products.Buffalo Sav Inc. Issues Allergy Alert On Undeclared Soy In Grandma's Perogies Potato & Bacon Perogi...Apr 8, 2014 - Buffalo SAV Inc of Buffalo, NY is recalling its 907 g (2 lb) package of Potato and Bacon perogies Grandma`s perogies brand because it may contain undeclared soy protein allergen. People who have an allergy or severe sensitivity to Soy protein run the risk of serious or life-threatening allergic reaction if they consume these products.Natural Grocers by Vitamin Cottage Issues Recall on Organic Black Peppercorns Due to Possible Healt...Apr 8, 2014 - Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado based natural grocery chain, is recalling multiple lots of Natural Grocers brand Organic Black Peppercorns as the product has the potential to be contaminated with Salmonella. Consumption of products containing Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.H Group, Inc. Issues Voluntary Allergen Alert on Undeclared Allergens in Caesar Salad with Caesar D...Apr 7, 2014 - H Group, Inc. of Framingham, MA is voluntarily recalling 509 units of Trader Giotto’s Caesar Salad with Caesar Dressing (SKU 05161) sold in the refrigeration section. These 509 individual salads are marked with the following date codes: "Sell By 04/6/14, 04/7/14 and 04/8/14."Apr 4, 2014 - Sprouts Farmers Market, Inc. (the “Company”) is recalling Organic Black Peppercorns sold under the Sprouts brand name from all stores. This product has the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, the elderly, and others with weakened immune systems.Whole Foods Markets Northern California Region Recalls Chipotle Chicken Wraps Due to Undeclared Fis...Apr 4, 2014 - Whole Foods Market’s Northern California region is recalling its Chipotle Chicken Wrap because it contains an undeclared allergen. The wrap, labeled as “Chipotle Chicken Wrap,” is filled with a Chicken Caesar wrap mix, which contains a fish allergen (anchovies) not declared on the Chipotle Chicken Wrap label.Apr 3, 2014 - KORU Pacific Packaging, today issued a voluntary recall of AH!LASKA®, because one lot (LOTI# 3280 BEST BY APR/2015) of the product may contain milk, which is not labeled in the ingredients. People who have an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume this product.
- Consumer Health Info
Apr 16, 2014 - Patients have many choices when it comes to hemophilia medications. FDAâ€™s regulation of the biologic products used as treatments ensures they are safe and effective.Apr 15, 2014 - The Food and Drug Administration (FDA) wants to ensure that all Americans, including those with limited English abilities, get important health information. That’s why FDA developed its Language Access Plan – to reach people with limited English proficiency in a language and manner they understand.Apr 14, 2014 - Many people have Easter lilies in their home this time of year, but this could be dangerous if they have a cat. FDA warns that cats can suffer acute kidney damage and even die after eating even a small part of a lily.Apr 11, 2014 - FDA warns consumers about undeclared drugs found in pain relief pills, mistakenly low results from a blood glucose meter and a weight loss product that was recalled because of tampering.Apr 10, 2014 - Irritable bowel syndrome (IBS) is an often misunderstood and underdiagnosed condition that affects about 15.3 million people in the United States. No one remedy works for all patients, so the Food and Drug Administration (FDA) is working to bring more treatments to the market.Mar 26, 2014 - FDA has formed a web of veterinary labs to assist one another in detecting potentially harmful substances in animal foods and tissues.Mar 25, 2014 - The Office of Minority Health (OMH) at the Food and Drug Administration (FDA) is working on several fronts to help ethnic and racial minority groups stay healthy and, when appropriate, is helping to raise awareness of available treatments for diabetes.Mar 19, 2014 - Description: FDA historians Suzanne Junod and John P. Swann explain the History Office's mission and describe the variety of services that it offers consumers, scholars and organizations outside the agency. Timed to the 46th anniversary of the office's start this March.Mar 19, 2014 - As college women travel domestically and abroad for spring break, FDA's Office of Women's Health (OWH) reveals timely health tips for this population. We also include brief information about the office's college campaign.Mar 19, 2014 - This page contains the most recent Consumer Update data available and links to past Consumer Update Analytics web pages.Mar 14, 2014 - FDA warns consumers about an undeclared drug found in a weight loss pill, a glass particle found in a solution used most often to loosen mucous, a subpotent drug to treat a genetic disorder in children and more.Feb 28, 2014 - The Food and Drug Administration Office of Orphan Products Development is launching web-based educational resources for patients and industry on rare disease topics. The page debuts on International Rare Disease Day Feb. 28; topics include how to interact with FDA.Feb 27, 2014 - FDA proposes bringing the Nutrition Facts Label--which has become one of the most recognized graphics in the world--up to date with changes to its design and content. Proposed updates include the addition of added sugars and changes to some serving size requirements.Feb 27, 2014 - As part of its proposed update of the Nutrition Facts Label, FDA is proposing changes to some food serving size and package labeling requirements to be more in line with what Americans are actually eating.Feb 27, 2014 - The changes proposed to the Nutrition Facts Label are based on advances in nutrition science, the latest consensus reports from public health agencies, and the most recent public health and nutrition surveys.Feb 19, 2014 - Knowing how to use an automated external defibrillator (AED) can mean the difference between life and death. Learn how these devices, found in many public places, work. Find out how knowing how to use one may help save someoneÃ¢â‚¬â„¢s life.Feb 6, 2014 - FDA warns consumers about dietary supplements that contain undeclared ingredients, glucose meters set with incorrect measure level and a dietary supplement that contains undeclared milk and more.Feb 4, 2014 - Meant to get vaccinated last fall to prevent the flu, but somehow didn't get around to it? Think it's too late to get one now? Not so. Find out why it's still not too late.Feb 4, 2014 - FDA is launching its first public health education campaign 'The Real Cost' to prevent and reduce tobacco use among at-risk young people ages 12-17. Mitch Zeller, director of FDA's Center for Tobacco Products, explains why the agency is undertaking this effort, and how it will work.Jan 30, 2014 - Cervical cancer is largely preventable and, if detected early, curable. The keys to cervical health come down to two kinds of tests evaluated by FDA. Learn the role FDA plays and what you can do to maximize your cervical health.
- News Releases
Apr 17, 2014 - The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age.Apr 17, 2014 - In a safety communication notice issued today, the U.S. Food and Drug Administration discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.Apr 16, 2014 - Los Genuinos, Inc., a Bayamon, Puerto Rico, food manufacturer, has agreed under terms of a court order not to process or distribute food until it addresses the unsanitary conditions found by U.S. Food and Drug Administration investigators. The company must also correct its product labels to accurately reflect the ingredients used in its products.Apr 15, 2014 - The U.S. Food and Drug Administration today approved Tanzeum (albiglutide) subcutaneous injection to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.Apr 10, 2014 - The U.S. Food and Drug Administration today approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D), expanding the indication for use to patients with atrioventricular (AV) block and less severe heart failure.Apr 7, 2014 - The U.S. Food and Drug Administration is warning consumers to immediately stop using Zi Xiu Tang Bee Pollen, marketed as a product for weight loss and body reshaping. The product contains at least one potentially harmful active pharmaceutical ingredient that is not listed on the product’s label.Apr 3, 2014 - Today, the U.S. Food and Drug Administration allowed marketing of an expandable, multi-sponge wound dressing to control the bleeding from certain types of wounds received in battle. For military use only, the XSTAT is a temporary dressing for wounds in areas that a tourniquet cannot be placed, such as the groin or armpit. The dressing can be used up to four hours, which could allow time for the patient to receive surgical care.Proposed health IT strategy aims to promote innovation, protect patients, and avoid regulatory dupl...Apr 3, 2014 - The U.S. Department of Health and Human Services (HHS) today released a draft report that includes a proposed strategy and recommendations for a risk-based regulatory framework for health information technology (health IT) that promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally-mandated report proposes to clarify federal regulatory oversight of health IT products based on a product’s function and the potential risk to patients who use it.Apr 3, 2014 - For more than a decade, the U.S. Food and Drug Administration has been working to address the important public health problems associated with the misuse, abuse, addiction and overdose of opioid analgesics, while at the same time working to ensure continued access to effective and appropriate medications for millions of Americans currently suffering from pain. I firmly believe that these goals are compatible, and that actions to address one should not be at the expense of the other.Apr 3, 2014 - The U.S. Food and Drug Administration today approved a prescription treatment that can be used by family or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine chest.Apr 2, 2014 - The U.S. Food and Drug Administration recently approved Oralair to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in people ages 10 through 65 years. Oralair is the first sublingual (under the tongue) allergen extract approved in the United States. After administration of the first dose at the health care provider’s office, where the patient can be observed for potential adverse reactions, Oralair can be taken at home.FDA approves first long-acting recombinant coagulation Factor IX concentrate for patients with Hemo...Mar 28, 2014 - The U.S. Food and Drug Administration today approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.Mar 28, 2014 - Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The medication is taken on a daily basis to reduce the frequency of migraine headaches.Mar 28, 2014 - The U.S. Food and Drug Administration recently ordered Jensen’s Old Fashioned Smokehouse Inc., a processor of smoked fish products in Seattle, Wash., to stop processing, preparing, packing, holding and distributing any food at or from its facility.Mar 21, 2014 - The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).Mar 20, 2014 - The U.S. Food and Drug Administration today approved the first implantable device for people 18 and older with severe or profound sensorineural hearing loss of high-frequency sounds in both ears, but who can still hear low-frequency sounds with or without a hearing aid. The Nucleus Hybrid L24 Cochlear Implant System may help those with this specific kind of hearing loss who do not benefit from conventional hearing aids.Mar 19, 2014 - The U.S. Food and Drug Administration today approved Impavido (miltefosine) to treat a tropical disease called leishmaniasis.Mar 17, 2014 - The U.S. Food and Drug Administration warns consumers that it has tested and found milk protein in 3-ounce bars of Simply Lite brand 50% Cacao Low Carb Sugar Free Dark Chocolate bearing the lot codes “Best By: 01 18 2015A” or “Best By: 01 19 2015A.” Milk is a major food allergen, but it is not declared as an ingredient on the label.Mar 11, 2014 - Today, the U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain.Feb 27, 2014 - The U.S. Food and Drug Administration today proposed to update the Nutrition Facts label for packaged foods to reflect the latest scientific information, including the link between diet and chronic diseases such as obesity and heart disease. The proposed label also would replace out-of-date serving sizes to better align with how much people really eat, and it would feature a fresh design to highlight key parts of the label such as calories and serving sizes.