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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)
Hong Lee Trading Inc. Issues an Alert on Undeclared Sulfites in Mut Dua Non Young Coconut Candy (St...Mar 7, 2014 - Hong Lee Trading Inc., at 225 Johnson Avenue, Brooklyn, NY 11206 is recalling “Mut Dua Non” Young Coconut Candy (Strips) because it contains undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.Mar 7, 2014 - Net Foods Import & Export at 711 2nd Street, Secaucus, NJ 07094 is recalling Net Food Brand Turkey Diced Apricots because they contain undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life threatening allergic reactions if the consume this product.Pfizer Initiates Nationwide Voluntary Recall of Two Lots of Pfizers Effexor XR 150 Mg Extended-Rele...Mar 6, 2014 - Pfizer Inc. is voluntarily recalling one lot of 30-count Effexor XR® (venlafaxine HCl) 150 mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules and one lot of 90-count Greenstone LLC-branded Venlafaxine HC1 150 mg extended-release capsules.Crown Food Distributors, Inc. Issues Allergy Alert on Undeclared Sulfites and Undeclared Yellow #6 ...Mar 6, 2014 - Crown Food Distributors, Inc. of North Bergen, NJ is recalling 25 oz. large round plastic containers of “Golden Natural Fruit Island” because they contain undeclared sulfites and undeclared FD & C yellow #6. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.Gretchens Shoebox Express Issues Allergy Alert for Limited Number of Greek Yogurt Raspberry & Lemon...Mar 5, 2014 - Out of the utmost caution and care for our customers, Gretchen’s Shoebox Express in Seattle, Washington, is initiating a voluntary recall of a limited number of Greek Yogurt Raspberry & Lemon Parfait cups sold under the Starbucks brand in Seattle and Portland regional Starbucks stores because the product was mislabeled and failed to declare the presence of eggs, an allergen.Baxter Initiates U.S. Voluntary Recall of One Lot of Peritoneal Dialysis Solution Due to Container-...Mar 5, 2014 - Baxter International Inc. announced today it has initiated a voluntary recall in the United States of a single lot of DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose 6000mL (Ambu-Flex II) to the hospital/user level. The recall is being initiated as a result of complaints of particulate matter, identified as mold, resulting from a leak in the container.House of Flavors Issues Voluntary Recall Due to Possible Undeclared Nut Allergen in Belmont Chocola...Mar 5, 2014 - March 5, 2014 - Ludington, Michigan – House of Flavors Ice Cream Company, based in Ludington, Michigan, is recalling its Belmont Chocolate Chip Cookie Dough Ice Cream because it's ingredients may include an undeclared nut allergen. Consumers who may have an allergy or severe sensitivity to nuts run the risk of serious or life-threatening allergic reaction if they consume this product.HC Schau and Sons issues allergy alert on undeclared Pine Nuts in Fresh To Go Tuscan Style Combo on...Mar 4, 2014 - HC Schau and Son of Woodridge Illinois is recalling 3422 individual 8oz units of ‘Fresh To Go Tuscan Style Combo on Tomato Basil Bread’ because it may contain undeclared Pine Nuts (tree nuts).Mar 4, 2014 - Plum Organics is voluntarily recalling a limited quantity of two varieties of its World Baby line of pouch products due to intermittent damage to the plastic spouts during manufacturing.Thoratec Corporation Issues Worldwide Urgent Medical Device Correction Letter to Update its Labelin...Mar 4, 2014 - On March 4, 2014, Thoratec Corporation initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II® LVAS Pocket System Controller (the “Pocket Controller”).ACTUALIZACIN (RETIRO EXTENDIDO) La compaa Roos Foods retira del mercado voluntariamente una varieda...Mar 4, 2014 - Roos Foods emitió comunicados de prensa para el retiro del mercado de nuestros productos de queso. Este retiro del mercado se ha ampliado para incluir a todos los tamaños de los productos y contenedores de la marca Santa Rosa de Lima Queso Duro Blando (queso duro), y de la marca Mexicana Queso Cojito Molido.Lehigh Valley Dairy Conducts Voluntary Recall of Lehigh Valley, Swiss Premium, and Price Chopper Br...Mar 4, 2014 - Impacts Lehigh Valley and Swiss Premium, distributed to both retail and foodservice locations in Pennsylvania, New Jersey, Delaware, Maryland, Virginia, Washington, DC, and West Virginia. Price Chopper brand orange juice was distributed only in Pennsylvania. All of these products have the sell by date of March 23rd and have the UPC codes listed below.Twin Marquis, Inc Issues Allergy Alert on Undeclared Milk in Specific Lots of its Cooked Noodle and...Mar 4, 2014 - Twin Marquis, Inc. of Brooklyn, NY, is recalling specific lots of Twin Marquis COOKED NOODLE and LO MEIN NOODLE listed below because they 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.(UPDATE) EXPANDED - Roos Foods Voluntarily Recalls Variety of Cheeses (listed below) Due to Possibl...Mar 1, 2014 - On February 23 and 25, 2014 Roos Foods issued press releases for the recall of our cheese products. This recall has been expanded to include all product sizes and containers of Santa Rosa de Lima Queso Duro Blando (hard cheese), and Mexicana Queso Cojito Molido.Jinsunmi International Inc. Issues A Voluntary Recall Of Its 17.98 oz Lotte Brand Frozen Fruit Bar ...Mar 1, 2014 - Jinsunmi Int’l Inc. is issuing the following update regarding its previously announced voluntary recall of plastic pouch of Lotte Brand frozen fruit bar (watermelon flavor)Mars Food North America Voluntarily Recalls Specific Batch and Item Number Representing Less Than 3...Mar 1, 2014 - Mars Food North America is voluntarily recalling one specific production lot of UNCLE BEN’S READY RICE Original Long Grain White Rice product, representing less than 3,500 cases.Unilever United States, Inc. Issues Allergy Alert for Limited Number of 20-Count Boxes of Popsicle ...Mar 1, 2014 - Unilever United States, Inc. is voluntarily recalling a limited number of 20-count boxes of Popsicle brand Orange, Cherry and Grape flavored ice pops because they may have been inadvertently exposed to milk, which is not listed as an ingredient on the label.EXPANDIDO - La Compania Roos Foods Retira del Mercado Voluntariamente una Variedad de Quesos (Enlis...Feb 25, 2014 - Roos Foods of Kenton, DE esta retirando del mercado los quesos nombrados arriba porque tienen el potencial de estar contaminados con Listeria monocytogenes, un organismo que puede causar infecciones serias y a veces fatales en niños pequenos, personas debiles o ancianas , y otros con sistemas inmunologicos debilitados. Aunque las personas sanas pueden sufrir solamente sintomas a corto plazo, tales como fiebre alta, dolor de cabeza severo, rigidez, nauseas, dolor abdominal y diarrea, la infeccion por Listeria puede causar abortos involuntarios y mortinatos entre las mujeres embarazadas.EXPANDED - Roos Foods Voluntarily Recalls Variety of Cheeses (listed below) Due to Possible Health ...Feb 25, 2014 - Update: Roos Foods has voluntarily expanded their February 23, 2014 recall to include all lots of Amigo and Mexicana brands of Requesón (part-skim ricotta in 15 oz. and 16 oz. plastic containers and all lots of Amigo, Mexicana and Santa Rosa De Lima brands of Queso de Huerta (fresh curd cheese).La Compania Roos Foods Retira del Mercado Voluntariamente Una Variedad de Quesos (Enlistados Abajo)...Feb 24, 2014 - Roos Foods of Kenton, DE esta retirando del mercado los quesos nombrados arriba porque tienen el potencial de estar contaminados con Listeria monocytogenes, un organismo que puede causar infecciones serias y a veces fatales en niños pequenos, personas debiles o ancianas, y otros con sistemas inmunologicos debilitados. Aunque las personas sanas pueden sufrir solamente sintomas a corto plazo, tales como fiebre alta, dolor de cabeza severo, rigidez, nauseas, dolor abdominal y diarrea, la infeccion por Listeria puede causar abortos involuntarios y mortinatos entre las mujeres embarazadas.
- Consumer Health Info
Mar 3, 2014 - This page contains the most recent Consumer Update data available and links to past Consumer Update Analytics web pages.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 - 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 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 - 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 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.Jan 23, 2014 - FDA warns consumers about ADHD medications with a risk of long-lasting erections, dietary supplements that contain undeclared ingredients, a nipple aspirate test claiming to be a substitute for a breast biopsy or mammography and more.Jan 23, 2014 - Head lice. Every parent's nightmare. Learn how to check for them, how to treat them, and how to avoid having them in your home.Jan 16, 2014 - FDA has learned that some over-the-counter wart removal products have caught fire during use. Learn how to use cryogenic (removal by freezing) wart removal products safely and other options for removing warts.Jan 14, 2014 - FDA's Cybercrimes Investigations Unit, a special team created in March 2013, is working with other domestic and international agencies to track down the operators and suppliers of web sites that illegally sell prescription medicines.Jan 10, 2014 - FDA has developed a new online reporting tool to encourage consumers and health care providers to report damaged, defective, or contaminated tobacco products, and unexpected health and safety problems associated with tobacco products.Jan 8, 2014 - The FDA is warning that some over-the-counter laxatives are potentially dangerous. Find out who may be affected and why these laxatives may cause side effects or even death.Dec 23, 2013 - FDA is warning consumers to avoid products marketed as dietary supplements that claim to prevent, treat or cure concussions and other traumatic brain injuries. These claims are fraudulent because the products have not been shown to be safe or effective for such purposes.Dec 20, 2013 - FDA warns consumers about eyeliner testing positive for lead, skin discoloration from anti-seizure medication, antibiotics found in protein products and more.Dec 19, 2013 - Portable bed rails can provide support to those who need them, but they can also pose some safety hazards. FDA offers tips for safer use.Dec 16, 2013 - Will antibacterial soaps, in addition to keeping you clean, reduce your risk of getting an infection? Data suggest that the risks associated with long-term, daily use, may outweigh the benefits. Learn why FDA is asking for more evidence.
- News Releases
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.Feb 25, 2014 - The U.S. Food and Drug Administration today approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy.Feb 21, 2014 - The U.S. Food and Drug Administration issued orders today to stop the further sale and distribution of four tobacco products currently on the market. The action marks the first time the FDA has used its authority under the Family Smoking Prevention and Tobacco Control Act to order a manufacturer of currently available tobacco products to stop selling and distributing them.Feb 19, 2014 - The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have set-up a new 'cluster' on pharmacovigilance (medicine safety) topics. Clusters are regular collaborative meetings between the EMA and regulators outside of the European Union, which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration. Building on the experience of previous regular videoconferences between the FDA and the EMA in this area and on the recent creation of the EMA’s Pharmacovigilance Risk Assessment Committee, this cluster will provide a forum for a more systematic and focused exchange of information on the safety of medicines.Feb 18, 2014 - The U.S. Food and Drug Administration today approved Northera capsules (droxidopa) for the treatment of neurogenic orthostatic hypotension (NOH). NOH is a rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure.Feb 18, 2014 - The U.S. Food and Drug Administration is announcing the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs. In August 2013, the FDA published a notice in the Federal Register (78 FR 51192) to solicit companies to voluntarily submit applications for participation in this two-year program. Thirteen prequalified companies have now been designated to take part, and will receive expedited entry for the importation of up to five selected drug products into the United States.Feb 14, 2014 - The U.S. Food and Drug Administration today approved Vimizim (elosulfase alfa), the first FDA approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome). Morquio A syndrome is a rare, autosomal recessive lysosomal storage disease caused by a deficiency in N-acetylgalactosamine-6-sulfate sulfatase (GALNS). Vimizim is intended to replace the missing GALNS enzyme involved in an important metabolic pathway. Absence of this enzyme leads to problems with bone development, growth and mobility. There are approximately 800 patients with Morquio A syndrome in the United States.Illegal prescription drug sellers arraigned on charges for smuggling illicit cancer drugs into the ...Feb 13, 2014 - Two individuals today were arraigned for charges that they, among other things, smuggled adulterated and misbranded prescription cancer treatments from Turkey and other countries into the United States and conspired to defraud the United States and the U.S. Food and Drug Administration. The drugs did not meet the FDA’s standards and had not been approved for distribution in the United States.Feb 12, 2014 - The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.Feb 10, 2014 - The FDA, the Centers for Disease Control and Prevention (CDC), and state and local officials have been investigating a cluster of illnesses associated with Uncle Ben’s Infused Rice Mexican Flavor sold in 5- and 25-pound bags.Updated FDA requirements for infant formula will maintain high-quality standards and help ensure he...Feb 6, 2014 - Today, the U.S. Food and Drug Administration published an interim final rule to further safeguard the health of infants fed infant formula in the United States. The rule, which sets standards for manufacturers to produce safe infant formula that supports healthy growth, is accompanied by two draft guidance documents for industry.Feb 5, 2014 - Today, the U.S. Food and Drug Administration announced that Commissioner Margaret A. Hamburg, M.D. will travel February 10-18 to India to further strengthen cooperation between the FDA and its Indian regulatory counterparts.Feb 4, 2014 - The U.S. Food and Drug Administration today announced the launch of a national public education campaign to prevent youth tobacco use and reduce the number of kids ages 12 to 17 who become regular smokers. 'The Real Cost' campaign is the FDA's first of several planned tobacco education campaigns using the new authority granted under the Family Smoking Prevention and Tobacco Control Act, signed into law by President Obama in 2009.Feb 3, 2014 - The U.S. Food and Drug Administration today approved the expanded use of the Dexcom G4 Platinum Continuous Monitoring System for patients with diabetes ages 2 to 17 years. The G4 Platinum System, which monitors blood glucose levels in people with diabetes, had been approved for patients ages 18 and older.Jan 31, 2014 - The U.S. Food and Drug Administration today approved Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder (“non-24”) in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorder in the blind that causes problems with the timing of sleep. This is the first FDA approval of a treatment for the disorder.Jan 31, 2014 - The U.S. Food and Drug Administration today proposed a rule that would require certain shippers, receivers, and carriers who transport food by motor or rail vehicles to take steps to prevent the contamination of human and animal food during transportation.Jan 28, 2014 - he U.S. Food and Drug Administration, in close coordination with the Wyoming Department of Agriculture (WDA) and the U.S. Department of Agriculture (USDA), has been working to address a tragic accident that occurred at the Western Sugar Cooperative’s Lovell, Wyo., manufacturing facility on Jan. 4, 2014.FDA prohibits Ranbaxy's Toansa, India facility from producing and distributing drugs for the U.S. m...Jan 23, 2014 - The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012.Jan 22, 2014 - The U.S. Food and Drug Administration today launched the advisory committee membership nomination portal, an online, interactive system that allows interested individuals to submit nominations for membership to any of the agency’s 33 advisory committees.Jan 17, 2014 - • The U.S. Food and Drug Administration is warning consumers not to eat raw or partially cooked oysters harvested from Copano Bay, in Aransas County, Texas, harvested between Dec. 26, 2013 and Jan. 9, 2014.