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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)
Dec 3, 2013 - Cargill's animal nutrition business today announced a voluntary recall of two of its Nutrena NatureWise poultry feeds due to incorrect levels of calcium. The affected products were manufactured at Cargill's facilities in Flora, Ill., Oklahoma City, Okla., Abilene, Texas, and Mineola, Texas, between May 1, 2013 and Nov. 21, 2013.Huxtables Kitchen Issues Voluntary Allergy Alert on Undeclared Allergens in Butternut Squash & Crea...Dec 2, 2013 - Huxtable’s Kitchen Inc. of Vernon, California is voluntarily recalling one specific lot of Trader Joe’s Butternut Squash & Creamed Spinach Gratin (SKU 96541) sold in the refrigerated section with “Use By 12/13/13” date, because it may not list wheat and egg in the ingredients. People who have an allergy or severe sensitivity to wheat and egg run the risk of serious or life-threatening allergic reaction if they consume this product.IQ Formulations Issues a Voluntary Recall of HYDRAVAX Dietary Supplement Due to Possible Undeclared...Nov 29, 2013 - IQ Formulations, of Sunrise, Florida is initiating a precautionary and proactive recall of all lots of its 45-capsule bottles of HYDRAVAX due to potential inclusion of an unlisted ingredient. The FDA has advised IQ Formulations that an analysis of a sample from one lot of HYDRAVAX (Lot # 2458, Exp # 07/16) revealed the presence of an undeclared ingredient – a diuretic.Nov 27, 2013 - Flat Creek Farm and Dairy of Swainsboro, GA has recalled 200 pounds of Heavenly Blue cheese, because of potential contamination. As of November 27, 2013 at 11:00am, according to Flat Creek records, all of the purchasers have been notified and more than 90% of the product has been collected or destroyed.Abbott Issues Voluntary Recall of Certain FreeStyle and FreeStyle Lite Blood Glucose Test Strips in...Nov 27, 2013 - Abbott today announced it is initiating a voluntary recall of 20 lots of FreeStyle® and FreeStyle Lite® Blood Glucose Test Strips in the United States. These lots of test strips may produce erroneously low blood glucose results when used with both "FreeStyle® Blood Glucose Meter" and "FreeStyle® Flash Blood Glucose Meter” [neither of which have been in production since 2010], as well as the OmniPod® Insulin Management System.Nov 27, 2013 - Baxter International Inc. announced today it has initiated a voluntary recall of one lot of Nitroglycerin in 5% Dextrose Injection due to particulate matter found in one vial. If infused, particulate matter could lead to potential venous and/or arterial thromboembolism (blockage of blood vessels.)Nov 27, 2013 - ZIP INTERNATIONAL GROUP LLC, 160 Raritan Center Parkway #6, Edison, NJ 08837, is recalling herring fillet in oil (FOSFOREL, ATLANTIKA) 400 gram in plastic packaging due to Listeria contamination.Nov 25, 2013 - CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in response to FDA inspectional findings of deficiencies in the Quality System regulations for Medical Device Manufacturers, 21 Code of Federal Regulation (CFR) Part 820 and lack of Premarket Approval (PMA) for devices sold or distributed in domestic commerce. The Viscoelastic products, intended for human and animal use, have been determined to be a public health concern due to distribution in the US without FDA approval, which evaluates the safety and efficacy of the product, and violations of the QSR regulations related to sterility, and biocompatibility that may result in the release of contaminated products.Nov 23, 2013 - Jayone Foods, inc. of Paramount, CA is voluntarily recalling All date codes of Trader Joe’s Dried Seaweed Salad with Spicy Dressing (SKU 97677), because it may contain traces of peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.Marina's German Bakery Issues Allergy Alert on Undeclared Almonds, Walnuts, and Hazelnuts in Pastry...Nov 21, 2013 - Marina's German Bakery of El Paso, Texas is recalling two-count packages of pastry products, because they may contain undeclared Almonds, Walnuts, or Hazelnuts. People who have an allergy or severe sensitivity to Almonds, Walnuts, or Hazelnuts run the risk of serious or life threatening allergic reaction if they consume these products. The two count packages of Assorted Pastries were distributed in El Paso,Texas at Fort Bliss Commissary and in Alamogordo, New Mexico at Holloman AFB Commissary.Deseo Rebajar Inc. Issues Voluntary Puerto Rico Recall of Adipotrim XT Due to Underclared FluoxetineNov 21, 2013 - Deseo Rebajar Inc., is voluntarily recalling lot #052012 of Adipotrim XT to the consumer level. The FDA laboratory analysis of this dietary supplement found to contain undeclared Fluoxetine.Nov 20, 2013 - Los Angeles, CA Tendex is voluntarily recalling Lot# F51Q of P-Boost and Lot # F51Q of NatuRECT to the consumer level. FDA laboratory analysis on Lot# F51Q of P-Boost, which the firm also labels as NatuRECT, has determined that this product contains undeclared tadalafil.Nov 19, 2013 - USPlabs LLC, Dallas, TX is voluntarily conducting a national recall of all lots and sizes of the OxyElite Pro dietary supplement products listed below. These products contain Aegeline, a synthesized version of a natural extract from the Bael tree.Blount Fine Foods Voluntary Recall of Wegmans New England Clam Chowder Due to Possible Undeclared C...Nov 19, 2013 - Blount Fine Foods of Fall River, MA is recalling a single lot code of Wegman’s branded refrigerated New England Clam Chowder in 16 ounce retail cup pack size because of undeclared crab allergen. People who have an allergy or severe sensitivity to crab run the risk of suffering serious or life-threatening reactions if they consume this product.Fossil Fuel Products, LLC, Issues Voluntary Nationwide Recall of RezzRX Due to Undeclared Active In...Nov 18, 2013 - Fossil Fuel Products, LLC, is voluntarily recalling lots QL110714A102 (20-count bottles) and QL110408B046 (single blister packs) of “RezzRX” to the consumer level.Jobbers Wholesale Issues Voluntary Recall of Rhino 5 Plus, Maxtremezen and Extenzone Marketed as a ...Nov 18, 2013 - Paramount, CA, Jobbers Wholesale is voluntarily recalling Lot No. KWAKPMC030505175957019 of Rhino 5 Plus, Lot No. JBP-L-1270-70 of Maxtremezen and Lot No. KWAKPMC03050517 of Extenzone to the consumer level. FDA analysis found these products to contain undeclared desmethylcarbondenafil and dapoxetine.La Boulange Cafe & Bakery Issues an Allergy Alert for Undeclared Allergen (Hazelnut) in Product Ina...Nov 15, 2013 - La Boulange Cafe & Bakery voluntarily initiated a product recall of 75 Soft Caramel Jams in 8.4 oz. jars with lot number 822713 as a precautionary measure. This product was sold exclusively in 20 La Boulange Café & Bakery stores in the San Francisco Bay Area.Nov 15, 2013 - Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company's recently initiated voluntary field action related to certain guidewires as a Class I recall. Based on an internal investigation following a limited number of complaints, including one patient injury, Medtronic began notifying hospitals and distributors worldwide the week of Oct. 21 that some models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach.New Reliance Traders, Inc.- Voluntarily Recalls Hashmi Surma Special Eyeliner Due to Elevated Lead...Nov 15, 2013 - New Reliance Traders, Inc announced it is voluntarily recalling all lots of Hashmi Surma Special Eyeliner because it was found to contain high levels of lead that could cause health problems to consumers, particularly infants, small children, and pregnant women.Nature's Pharmacy and Compounding Center Issues Voluntary Recall of All Sterile Compounded Products...Nov 15, 2013 - ature's Pharmacy and Compounding Center of Asheville, NC is voluntarily recalling of all lots of sterile products compounded by the pharmacy that are not expired to the consumer level. The product will be in the form of an injectable drug or an eye drop.
- Consumer Health Info
Dec 3, 2013 - This page contains the most recent Consumer Update data available and links to past Consumer Update Analytics web pages.Nov 27, 2013 - FDA warns consumers about a hepatitis health advisory linked to supplement use, and undeclared ingredients found in a dietary supplement and more.Nov 25, 2013 - The Interstate Travel Program is responsible for inspecting the food, water and waste-disposal systems in all commercial transport vehicles that travel from one state to another. However, its involvement begins long before the food and water are loaded aboard.Nov 19, 2013 - FDA just launched a new version of its website that works well with the most popular mobile devices, including smartphones and tablets, while continuing to support traditional desktop and laptop computers.Nov 18, 2013 - Texas-based USPLabs has agreed to recall and destroy certain OxyElite Pro products, dietary supplements linked to cases of acute liver failure and acute non-viral hepatitis. The supplement had been advertised for losing weight and building muscle.Nov 14, 2013 - Scientists believe that acrylamide - a chemical that can form in some foods - may cause cancer in humans. Learn more about acrylamide and steps you can take to cut down on the amount that you and your family consume.Nov 7, 2013 - FDA targets partially hydrogenated oils, the major source in processed foods of trans fat, which has been linked to heart disease.Nov 6, 2013 - Hearing aids and personal amplification devices are not interchangeable. Consumers who suspect hearing loss should visit a health care specialist to avoid serious risks.Nov 5, 2013 - Non-steroidal anti-inflammatory drugs (NSAIDS) are used in both humans and animals to help relieve pain. But when given to pets, they can carry certain risks. Find out how to use NSAIDS safely with your pets and side effects that can signal danger.Nov 4, 2013 - Anabolic steroids pose special risks to teens, whose bodies are still developing. The damage may be irreversible in some cases.Oct 31, 2013 - A new strategic plan and proposed new rule aim to prevent shortages of critical drugs and biologics.Oct 29, 2013 - FDA warns consumers about supplements that contain a potentially dangerous stimulant, a recall of infant pain reliever, and sexual enhancement products with undeclared ingredients that could cause health problems.Oct 29, 2013 - A new report outlines FDA's role in advancing personalized medicine, the tailoring of medical treatments to the characteristics, needs and preferences of an individual patient.Oct 25, 2013 - For the first time, FDA is proposing a new set of protections for the production of animal foods, including the food pet owners give their companion animals and feed that farmers give their livestock. The goal: To keep all animal foods from being contaminated.Oct 24, 2013 - Many stores and websites are selling these decorative lenses illegally without a prescription and putting your vision at risk. Here's how to safely get those Twilight vampire eyes, multi-color lenses, or other fashion lenses.Oct 23, 2013 - Heartworm disease is fatal to pets. The good news: You can protect your pet from this disease. Learn more about the dangers of heartworm disease and the importance of year-round prevention.Oct 22, 2013 - Thousands of dogs and some cats in the U.S. have gotten sick after eating jerky pet treats. Despite extensive investigations, the cause remains elusive. FDA scientists are broadening the search for the cause by soliciting samples and information from consumers and veterinarians.Oct 21, 2013 - Fishermen trained by FDA scientists are performing sophisticated lab tests on clams while far out to sea -- a novel approach that has allowed the reopening of thousands of miles of ocean to clamming off the coast of New England.Sep 30, 2013 - It's Hispanic Heritage Month. In this story, FDA recounts the history of the agency's San Juan District office, which ensures that FDA-regulated products made or sold in Puerto Rico and the U.S. Virgin Islands comply with FDA regulations.Sep 26, 2013 - The more than 135 million doses of influenza vaccine produced this flu season include those made by new technologies and one that protects against four strains of the flu virus, rather than the usual three.
- News Releases
Dec 6, 2013 - The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Solvadi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.Dec 6, 2013 - The U.S. Food and Drug Administration today approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease.Dec 4, 2013 - The U.S. Food and Drug Administration has reached a $1.25 million settlement of a civil money penalty action against Advanced Sterilization Products (ASP), a division of Ethicon Inc., a Johnson & Johnson company, and two of ASP’s executives alleging that ASP manufactured and distributed adulterated and misbranded sterilization monitoring products.FDA issues safety communication on HeartStart automated external defibrillators from Philips Health...Dec 3, 2013 - Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the U.S. Food and Drug Administration said today in a new safety communication for users of these previously recalled devices.Nov 27, 2013 - A Bakersfield, Calif., food company has agreed under terms of a court order not to process or distribute food until after it cleans up the unsanitary conditions found by U.S. Food and Drug Administration inspectors.FDA study helps provide an understanding of rising rates of whooping cough and response to vaccinat...Nov 27, 2013 - A new study is helping to provide a better understanding of vaccines for whooping cough, the common name for the disease pertussis. Based on an animal model, the study conducted by the U.S. Food and Drug Administration (FDA) and published November 25, 2013, in The Proceedings of the National Academy of Sciences, shows that acellular pertussis vaccines licensed by the FDA are effective in preventing the disease among those vaccinated, but suggests that they may not prevent infection from the bacteria that causes whooping cough in those vaccinated or its spread to other people, including those who may not be vaccinated.Nov 25, 2013 - The U.S. Food and Drug Administration today announced it is requiring the removal of certain restrictions on prescribing and use of the diabetes drug Avandia (rosiglitazone) to reflect new information regarding the cardiovascular risk of the medicine. Today’s actions are consistent with the recommendations of expert advisory committees.Nov 22, 2013 - The U.S. Food and Drug Administration today approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.Nov 22, 2013 - The U.S. Food and Drug Administration today approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in people 18 years of age and older who are at increased risk of exposure to the H5N1 influenza virus.Nov 22, 2013 - The U.S. Food and Drug Administration today expanded the approved uses of Nexavar (sorafenib) to treat late-stage (metastatic) differentiated thyroid cancer.Nov 19, 2013 - Today the U.S. Food and Drug Administration allowed marketing of four diagnostic devices that can be used for high throughput gene sequencing, often referred to as “next generation sequencing” (NGS). These instruments, reagents, and test systems allow labs to sequence a patient’s DNA (deoxyribonucleic acid).Nov 18, 2013 - At the request of the U.S. Food and Drug Administration, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, Inc., located in Norcross, Ga., after FDA investigators found the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent. The retail value of the seized products is more than $2 million.Nov 14, 2013 - The U.S. Food and Drug Administration today approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.Nov 13, 2013 - The U.S. Food and Drug Administration today approved Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer.Nov 10, 2013 - The U.S. Food and Drug Administration announced today that USPlabs LLC, of Dallas, Texas, is recalling certain OxyElite Pro dietary supplement products that the company markets. The company took this action after receiving a letter from the FDA stating that the products have been linked to liver illnesses and that there is a reasonable probability that the products are adulterated.Nov 8, 2013 - The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.Nov 8, 2013 - The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).Nov 8, 2013 - A proposed U.S. Food and Drug Administration rule would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling.Nov 7, 2013 - The U.S. Food and Drug Administration announced its preliminary determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” for use in food. The FDA’s preliminary determination is based on available scientific evidence and the findings of expert scientific panels.FDA: Janssen Pharmaceuticals, Inc. to plead guilty and pay over $1.6 billion to resolve allegations...Nov 4, 2013 - On behalf of the U.S. Food and Drug Administration, the U.S. Department of Justice today announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) of Titusville, N.J., and a $400 million criminal fine for introducing a misbranded drug, Risperdal (risperidone), into interstate commerce. A Johnson & Johnson Company, JPI must also pay $1.25 billion under a separate civil settlement concerning the same drug. The combined criminal plea and civil settlement agreement related to Risperdal totals $1,673,024 billion.