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- Vaccine Approved for Japanese Encephalitis
TUESDAY, March 31 (HealthDay News) -- The Ixiaro vaccine to prevent Japanese encephalitis (JE) has been approved by the U.S. Food and Drug Administration as the only sanctioned JE vaccine in the United States. The mosquito-transmitted virus is...
- 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)
LL Bakery, Inc. Announces the Recall of White Farm Enriched White Bread, Butter Farm Enriched White...May 21, 2013 - LL Bakery Inc. of Torrance, CA is recalling all White Farm Enriched White Bread, Butter Farm Enriched White Bread, and Italian Cream Danish because product labels fail to declare the allergen "milk", in the whey powder listed in their ingredient statements. 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 these products.May 20, 2013 - Eco-Cuisine of Boulder, Colorado is recalling all lots of T3314 Basic Brownie Mix, T3333 Betty Brownie Mix with Vanilla, T3388 Ground Beef Style Quick Mix, T3394 Sausage Style Quick Mix, T3416 Chocolate Cookie Mix, T3417 Lemon Muffin Mix, and T3418 English Scone Mix, CM25COOK Basic Cookie Mix 25 lb. bag, CM25MUFF Basic Muffin Mix 25 lb. bag, CM25SCON Basic Scone Mix 25 lb. Bag, 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.Sandoz US Announces Voluntary Nationwide Recall of two lots of Methotrexate Sodium, USP, Injectable...May 20, 2013 - Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US, due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer. The product is preservative free.May 20, 2013 - Galveston Shrimp Company has issued a precautionary voluntary recall of its pre-packaged Texas Gulf Shrimp due to foreign material found in a bag. The pre-packaged bags are shipped to HEB Stores. Customers who recently purchased pre-packaged Gulf Shrimp are encouraged to check their refrigerators and/or freezers.Pentec Health Announces Limited Voluntary Recall of Certain Compounded Prescription Therapies for R...May 17, 2013 - Pentec Health, Inc. has decided to initiate a limited, voluntary recall of in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated with one of its laminar flow hoods used in compounding. The recall covers renal therapies that were compounded in this hood on or before May 2, 2013.Tropical Valley Foods Issues Allergy Alert on Undeclared Milk and Walnuts in Next by Nature Dark Ch...May 17, 2013 - Tropical Valley Foods Inc. of Plattsburgh, NY, is recalling next by Nature DARK CHOCOLATE BANANAS, 3 oz. bags, due to undeclared milk and walnuts. People who have an allergy to milk and/or walnuts run the risk of serious or life-threatening allergic reaction if they consume this product.May 17, 2013 - Rural King Distributing of Mattoon, IL is recalling 205 tons of Deer Corn, because it has the potential to be contaminated with aflatoxin. Aflatoxin is a naturally occurring mold by-product.May 16, 2013 - May 10, 2013 - Symbios Medical Products initiated a voluntary recall of all GoPump Rapid Recovery System kits and GOBlock Kits manufactured with flow control components assembled prior to July 2012. These products have been found to potentially cause excessively high flow rates, which presents a risk of patient toxicity and serious injury (e.g., seizure, dysrhythmia, death) due to the rapid influx of medication particularly in patients with low body mass or advanced age.Additional Lots Added: Voluntary Nationwide Recall of 21 Lots of Piperacillin and Tazobactam for In...May 10, 2013 - May 10, 2013 – Weston, Florida: Apotex Corp. announced today that it is conducting, on behalf of the manufacturer Hospira, Inc., a voluntary nationwide recall of 21 lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams, NDC number 60505-0773-00 to the hospital / healthcare provider /user level. The impacted lots of Piperacillin and Tazobactam for Injection, USP 40.5 grams may show precipitation / crystallization in IV bag or IV line after reconstitution.Beamonstar Products Issues Voluntary Nationwide Recall of SexVoltz, Velextra, & Amerect Marketed as...May 10, 2013 - Queen Creek, AZ, BeaMonstar Products is voluntarily recalling all of SexVoltz brand SKU’s 626570609490, 827912089028, 626570617877, 626570615316, 626570615316 Velextra brand SKU’s 626570613855, 626570619055, 626570617860, 626570617563 Amerect SKU’s 626570619031, 626570619628 capsules to the consumer level. Laboratory analysis conducted by the FDA on SexVoltz and Velextra has determined these products contain undeclared tadalafil. Amerect is voluntarily recalled because it has the potential to contain undeclared tadalafil. Tadalafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the products unapproved new drugs.Hannaford Supermarkets Issues Allergy Alert for Two Bakery Cookie Products That May Contain Undecla...May 10, 2013 - Hannaford Supermarkets is recalling two products sold in the bakery section because they may contain nuts that are not listed on the product packaging label. Individuals who have an allergy or severe sensitivity to any nuts may run the risk of serious or life-threatening allergic reaction should they consume these items.Smart & Final Expands Recall to Include Additional Production Dates; Allergy Alert - Undeclared Whe...May 10, 2013 - Smart & Final of Los Angeles, Calif., which previously announced a recall of certain production dates of 2.5 lb - La Romanella Tri-Color Cheese Tortellini, is expanding its recall to include additional production dates due to undeclared wheat, eggs and milk. People who have an allergy or severe sensitivity to wheat, eggs and/or milk run the risk of serious or life-threatening allergic reaction if they consume these products.In Cooperation with FDA, The Compounding Shop, LLC Declares a Voluntary Recall of All Lots of Steri...May 10, 2013 - The Compounding Shop, LLC is conducting a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired. The recall is being initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.Krinos Foods, LLC. is Expanding its April 28, 2013 Recall to Include Additional Expiration Dates Ja...May 10, 2013 - Krinos Foods, LLC. of Long Island City, New York is voluntarily recalling its TAHINI sesame paste, 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. 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.Dairy Fresh Conducts Voluntary Recall of IGA Brand Vanilla & Chocolate 1.75 Quart Ice Cream Because...May 10, 2013 - Dairy Fresh is voluntarily recalling a specific batch of IGA Brand “Vanilla & Chocolate” Ice Cream (1.75 quart, 1.66L) with the plant code “3783” and a SELL BY date of 08-13-13 because it incorrectly contains Heavenly Hash ice cream, which contains almonds, coconut, and soy, which are allergens not declared on the carton. People who have an allergy or severe sensitivity to almonds, coconut, or soy run the risk of serious or life-threatening allergic reaction if they consume this product.Whole Foods Market Recalls Mislabeled Curried Chicken Salad and Vegan Chickn Salad Sold at the Cold...May 9, 2013 - May 9, 2013 - CAMBRIDGE, MA. – Whole Foods Market is recalling bulk curried chicken salad and bulk vegan curried chick'n salad because in some stores these items may have been sold with reversed labels causing undeclared soy and egg allergens. Due to the label mix-up, allergens were undeclared; the vegan chick'n salad contains soy, and the curried chicken salad contains egg.Pure Herbs Ltd. Issues Allergy Recall Alert on Undeclared Allergens (Milk and Soy) in Protein Extra...May 9, 2013 - Today, Pure Herbs Ltd., Sterling Heights, MI is voluntarily recalling the 4oz and 1oz bottles of Protein Extract because they contain undeclared allergens - milk and soy. This labeling error was discovered during a routine Food and Drug Administration (FDA) inspection when a review of the ingredients found that milk and soy allergen ingredients were not listed on our main label.Bimeda Inc. on Behalf of Manufacturer Bimeda-MTC Animal Health Inc. Issues Voluntary Nationwide Rec...May 9, 2013 - Bimeda Inc., on behalf of the manufacturer, Bimeda-MTC Animal Health Inc. is voluntarily recalling one lot of Calcium Gluconate, one lot of Dextrose 50%, and one lot of Hypertonic Saline, all of which are in the form of injectable fluids, to the user level. These injectable fluids are being recalled as a precautionary measure; because of departures from customary sterility procedures, sterility cannot be entirely assured.May 8, 2013 - Nutraceutical company XYMOGEN in Orlando, Fla., is recalling artriphen, a product recommended for the support of healthy joint function, because it contains traces of the undeclared allergens soy and milk.Beamonstar Products Issues Voluntary Nationwide Recall of SexVoltz, Velextra, & Amerect Marketed as...May 7, 2013 - Queen Creek, AZ, BeaMonstar Products is voluntarily recalling all of SexVoltz brand SKU’s 626570609490, 827912089028, 626570617877, 626570615316, Velextra brand SKU’s 626570619475, 626570619475, 626570619475, 626570619475 , Amerect SKU’s 626570619031, 626570619598 capsules to the retail level. Laboratory analysis conducted by the FDA on SexVoltz and Velextra has determined these products contain undeclared tadalafil. Amerect is voluntarily recalled because it has the potential to contain undeclared tadalafil. Tadalafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the products unapproved new drugs.
- Consumer Health Info
May 21, 2013 - FDA’s MedWatch Safety Alerts alert consumers to problems with quality or safety of medical products. The April listing includes products such as anti-seizure medications, multivitamin supplements, mattress covers, blood glucose meters and compounded drugs.May 20, 2013 - This page contains the most recent Consumer Update data available and links to past Consumer Update Analytics web pages.May 15, 2013 - FDA has taken steps on multiple fronts to protect consumers from the skin damage that can be caused by too much exposure to the sun. This is the first summer in which FDA's new rules governing sunscreen labeling are in effect. And FDA is supporting "DonÃ¢â‚¬â„¢t Fry Day" on May 24.May 14, 2013 - GMOs, genetically modified organisms, biotech foods, or genetically engineered foods - whatever name they're called - seem to be a captivating topic. Learn more about them and how they are regulated in this FDA Consumer Update.May 10, 2013 - Pregnant and breastfeeding women can turn to FDA's Office of Women's Health for important health information, including details about the risks and benefits of taking medication during this special time.May 10, 2013 - Keep Listeria at bay by keeping your refrigerator temperature low and carefully cleaning kitchen surfaces.May 7, 2013 - Exposure to ultraviolet (UV) radiation - whether outdoors from the sun, or indoors under a sunlamp - causes damage to your skin, including skin cancer. Find out how FDA is proposing to change how it regulates sunlamps, including requiring labeling recommending that young people not use these devices.May 2, 2013 - Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor discusses his concerns about the increasing number of caffeinated products and their impact on children.Apr 30, 2013 - David White, chief science officer in FDA's Office of Food and Veterinary Medicine, and Edward Cox, director of FDA's Office of Antimicrobial Products, explain the efforts FDA is making to combat the public health impact of antibiotic-resistant bacteria.Apr 25, 2013 - FDA is working to increase minority participation in the clinical trials that test new medical products. Members of minority groups are move vulnerable to certain diseases, but are under-represented in these trials.Apr 24, 2013 - A tool invented by FDA scientists is being deployed in a partnership to fight counterfeit malaria drugs. Testing is planned in Ghana. More than a third of malaria drugs in Sub-Saharan Africa and Southeast Asia are counterfeit or substandard.Apr 23, 2013 - FDA's Patient Liaison Program helps to bring the unique perspective of patients, family members, caregivers and patient advocates to the decision-making processes of the FDA. Learn the many ways you can get involved and become part of the process that regulates food and drugs.Apr 16, 2013 - At FDA, achieving equality in health and health care is part of the mission of the Office of Minority Health. The office was established in 2010 to help the agency address the needs of Americans who may be more vulnerable because of their race, ethnicity or other factors.Apr 15, 2013 - FDA is inviting consumer comments on a petition from two dairy industry groups to change the standard of identity for flavored milk and 17 other dairy products. This would make it possible for manufacturers of some artificially sweetened dairy products to avoid stating that fact on the front of their packaging.Apr 11, 2013 - FDA's efforts to get dietary supplements containing the stimulant DMAA off the market illustrates the agency's role in regulating dietary supplements and serves as a warning to consumers.Apr 8, 2013 - At the Food and Drug Administration's National Center for Toxicological Research in Arkansas, scientists are using zebrafish as models for studying how certain drugs could affect humans. See how these tiny, transparent fish may make a difference to your health someday.Mar 26, 2013 - FDA finds that labels on over-the-counter nicotine replacement therapy products can be changed to allow consumers to use them longer and at the same time as other nicotine-containing products.Mar 25, 2013 - Are temporary tattoos just a little harmless fun? Not necessarily, say FDA experts. Learn the potential dangers of temporary tattoos made with henna ink and how they have sent many people to the emergency room.Mar 21, 2013 - Migraines affect more than 30 million Americans. Learn about what causes migraines, the newest, FDA-approved form of migraine treatment—a patch—as well as other treatments and things you can do to prevent these painful headaches.Mar 15, 2013 - Skip those “Law and Order” reruns. Listen to the real thing when an FDA special agent discusses how criminals selling counterfeit drugs online to U.S. consumers are brought to justice. Click here [www.fda.gov/AboutFDA/Transparency/Basics/ucm343200.htm] to find out how to connect to this 30-minute webinar.
- News Releases
FDA expands alert to health care providers about lack of sterility assurance of all sterile drug pr...May 18, 2013 - The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these products should not be administered to patients.May 17, 2013 - The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration (FDA), is seeking a preliminary injunction in the U.S. District Court for the Eastern District of New York against New York City Fish, Inc., and several key employees for manufacturing and distributing ready-to-eat fish products under insanitary conditions causing them to become adulterated.May 15, 2013 - The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.May 15, 2013 - The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.FDA approves first companion diagnostic to detect gene mutation associated with a type of lung canc...May 14, 2013 - The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10 percent of non-small cell lung cancers (NSCLC).May 14, 2013 - On May 10, the U.S. Food and Drug Administration approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from ruptured blood vessels in the brain (subarachnoid hemorrhage). Nimodipine previously was available only as a liquid-filled gel capsule.May 13, 2013 - The U.S. Food and Drug Administration has released a new tool to help bolster the food industry’s defense measures against an act of intentional food contamination. The Food Defense Plan Builder is a comprehensive, easy-to-use software program designed to help owners and operators of food facilities—ranging from primary production and manufacturing to retail and transportation—develop customized plans to minimize the risk of intentional contamination at their individual food facilities.May 10, 2013 - The U.S. Food and Drug Administration is warning consumers not to consume any juice products or other beverages from Juices Incorporated (aka Juices International and Juices Enterprises) of Brooklyn, N.Y. The company's carrot and beet juice products have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause botulism, a serious and potentially fatal foodborne illness. Consumers are warned not to consume these products even if they do not look or smell spoiled.May 10, 2013 - The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.FDA alerts health care providers of lack of sterility assurance of drug products from The Compoundi...May 8, 2013 - The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.May 6, 2013 - Today, the U.S. Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.May 6, 2013 - The U.S. Food and Drug Administration is alerting health care providers and patients that medications including and related to valproate sodium can cause decreased IQ scores in children whose mothers took the medication during pregnancy. Therefore, these drugs are being contraindicated for (should never be used by) pregnant women for the prevention of migraine headaches. Valproate products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of a...Apr 30, 2013 - The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older.Apr 30, 2013 - The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare disease or condition.Apr 29, 2013 - The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States.FDA launches partnership to protect against counterfeit anti-malarial medicines with FDA-developed ...Apr 24, 2013 - The U.S. Food and Drug Administration today announced a public-private partnership to help identify counterfeit or substandard anti-malarial medicines, including falsified products, with the deployment of the FDA-developed Counterfeit Detection Device, called CD-3.Apr 21, 2013 - Balanced Solutions Compounding Pharmacy (Balanced Solutions), a division of Axium Healthcare Pharmacy, Inc., of Lake Mary, Fla., is voluntarily recalling all lots of its sterile non-expired drug products due to a lack of sterility assurance and concerns with product quality controls.Apr 16, 2013 - The U.S. Food and Drug Administration today approved updated labeling for Purdue Pharma L.P.’s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).FDA issues alert about lack of sterility assurance of drug products from ApotheCure, Inc. and NuVis...Apr 15, 2013 - The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that sterile drug products made by ApotheCure, Inc. and sterile lyophilized (freeze dried powder) drug products made by NuVision Pharmacy were produced under conditions that could create a high potential for contamination. These products should not be administered to patients.Apr 15, 2013 - U.S. Marshals have seized food products at a Ridgewood, N.Y. warehouse that manufactures and distributes kosher food products, after investigators from the U.S. Food and Drug Administration found widespread rodent infestation in the facility.