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- FDA Alerts
- Recalls (Drug & Food)
Hospira Issues A Voluntary Nationwide Recall of One Lot of 0.9% Sodium Chloride Injection, USP, 250...Mar 5, 2015 - Hospira, Inc. (NYSE: HSP), announced today that it will initiate a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL VisIV flex container (NDC 0409-7983-25, Lot 45-110-C6, Expiry 1MAR2016) to the user level due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as human hair free-floating within the solution.Maternal Science, Inc. Issues Allergy Alert on Undeclared Milk in healthy mama Boost It Up!tm Mango...Mar 4, 2015 - Maternal Science, Inc. of Montvale, NJ, is voluntarily recalling healthy mama® Boost It Up!tm Drink because it contains undeclared milk (whey protein isolate). People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product.Ateeco, Inc., Maker of Mrs. Ts Pierogies, Issues Voluntary Regional Product Recall of Mozzarella, T...Mar 2, 2015 - On February 27, 2015, Mrs. T’s Pierogies, of Shenandoah, PA, announced the voluntary recall of specific lots of its Mozzarella, Tomato & Basil variety of pierogies, due to safety concerns. The affected product was distributed to a limited number of retail customers and is being recalled due to plastic contamination in the product which may be a choke hazard.Talenti Gelato & Sorbetto Issues Allergy Alert for Limited Number of Jars of Talenti Gelato & Sorbe...Feb 28, 2015 - Talenti Gelato & Sorbetto, a Unilever company, is voluntarily recalling a limited number of jars of Talenti Gelato & Sorbetto Sea Salt Caramel Gelato because they may inadvertently contain peanuts (as peanut butter), which are not listed as an ingredient on the label. Persons who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume this product.Feb 27, 2015 - HeartWare International, Inc. (Nasdaq: HTWR), is issuing a voluntary Urgent Medical Device Recall in the United States related to older HeartWare Ventricular Assist System Controllers, which were distributed in the U.S. during the clinical trial period prior to Food and Drug Administration (FDA) approval in 2012. HeartWare has commenced this field action in other countries in recent weeks.Heritage Pharmaceuticals Initiates a Nationwide Voluntary Recall of Colistimethate for Injection US...Feb 25, 2015 - Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Heritage. Both products are sold in single vial mono-cartons in case packs of ten (10).Fairway Like No Other Market Recalls Fairway Brand Raw Hazelnuts (Filberts) Because of Possible Hea...Feb 25, 2015 - Fairway “Like No Other Market” of New York, NY, is recalling Fairway brand Raw Hazelnuts (Filberts), 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.Purina Animal Nutrition LLC Recalls One Lot of DuMOR Sheep Formula, 50 lbs. Bags Due to Potentially...Feb 24, 2015 - Purina Animal Nutrition LLC has initiated a limited voluntary recall of DuMOR Sheep Formula in Florida due to the potential for a higher-than-acceptable level of copper, which can cause health issues and potential mortality. There has been one report of sheep mortality associated with the single lot that is being recalled.Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Atracurium Besylate Injection, US...Feb 23, 2015 - Schaumburg, IL,Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent. Sagent has initiated this voluntary recall of Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer’s site potentially impacting product sterility. Non-sterility of a drug administered via the intravenous route has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised.Urgent: El Popocatepetl Ind., Inc. issues an allergy alert on Undeclared Milk and Yellow #5 in 8 in...Feb 21, 2015 - El Popocatepetl Ind., Inc. of Chicago, Illinois is voluntarily recalling El Popocatepetl’s 8 in. Chipotle, Spinach Pesto, and Sun Dried Tomato Wraps because they may contain undeclared milk and Yellow #5. People who have allergies to milk and/or Yellow #5 run the risk of serious or life-threatening allergic reaction if they consume these products.Feb 20, 2015 - WhiteWave Foods is voluntarily recalling 7.5 oz packages of Horizon Cheddar Sandwich Crackers because they may contain undeclared peanuts. People who have an allergy or sensitivity to peanuts run the risk of serious or life- threatening allergic reaction if they consume this product.CON YEAGER SPICE COMPANY'S REVISED VOLUNTARY RECALL FOR GROUND CUMIN AND SEASONING BLENDS (CONTAINI...Feb 20, 2015 - FOR IMMEDIATE RELEASE-February 20,2015 -New Castle,PA and Zelienople,PA - Con Yeager Spice Company has previously issued a voluntary recall for multiple sized packages under multiple brand names of ground cumin and multiple seasoning blends (containing ground cumin) due to undeclared Peanut allergens in the ground cumin.The company is revising its list of affected products to correct several brand names and provide additional gift box information.Old Home Kitchens Issues Allergy Alert and Voluntary Recall on Undeclared Pecans In "Sock It To Me ...Feb 20, 2015 - Old Home Kitchens is voluntarily recalling "Sock It To Me Creme Cake" under the "the Bakery baked with pride" label with a production code of 150301100 thru 150310700 ink jet coded on plastic dome, because they contain undeclared pecans. People who have allergy or sensitivity to pecans run the risk of serious or life threatening allergic reaction if they consume these products.Feb 20, 2015 - Hummingbird Wholesale in Eugene Oregon is recalling 110 jars of Hummingbird Brand Organic Chocolate Hazelnut Butter that may contain undeclared milk. People who have an allergy or severe sensitivity to milk products run the risk of serious or life threatening allergic reaction if they consume this product.Feb 19, 2015 - Kirsch Mushroom Co. Inc. of 751 Drake Street Bronx NY, is recalling its Chilean Mushrooms that were purchased from Nov 1st2014 to Dec 20th 2014 because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.Chocolate By Design Inc. Issues Allergy Alert on Undeclared Egg in Milk Chocolate Assorted Characte...Feb 19, 2015 - Chocolate By Design Inc. of Ronkonkoma, NY, is recalling its Milk Chocolate “Assorted Character Icing Pops”, “Christmas Icing Pops” and “Triple Heart Icing Pops” because they contain undeclared eggs. The Icing Pops may also contain trace amounts of FD&C colors Yellow 5 or 6, Red 3 or 40, and/or Blue 1.Spiceco Issues A Correction Regarding Allergy Alert On Undeclared Peanut Allergen In 5 Oz. Containe...Feb 18, 2015 - Spiceco of Avenel, NJ is recalling PRIDE OF SZEGED SWEET HUNGARIAN PAPRIKA because it may contain undeclared Peanut Allergen. People who have an allergy or severe sensitivity to Peanut Allergen run the risk of serious or life-threatening allergic reaction if they consume this product.Goya Foods, Inc. Announces Recall of Kirby Brand Black Beans with Creole Seasoning and Goya Brand B...Feb 17, 2015 - Certain lots of Kirby brand black beans with creole seasoning, 29 oz. size and Goya brand black bean soup, 29 oz. size made by Goya Santo Domingo, S.A. are being recalled. The voluntary recall was announced after the Company was notified by one of its ingredient suppliers that one lot of ground cumin had potentially been produced with undeclared peanut protein.Unilever United States, Inc. Issues Allergy Alert for Limited Number of Tubs of Breyers No Sugar Ad...Feb 17, 2015 - Unilever United States, Inc. is voluntarily recalling a limited number of tubs of Breyers® No Sugar Added Salted Caramel Swirl because they may inadvertently contain almonds, which are not listed as an ingredient on the label. Persons who have an allergy or severe sensitivity to almond run the risk of a serious or life-threatening allergic reaction if they consume this product.Whole Foods Markets Glastonbury Store Recalls Divine Treasures 100,000 Smooches Vegan Chocolate Due...Feb 14, 2015 - Whole Foods Market is recalling “Divine Treasures 100000 Smooches” sold at the Glastonbury, Connecticut location due to an undeclared peanut allergen. The product was sold in the Glastonbury store through February 11, 2015 and includes any Divine Treasures 1000000 Smooches with “Sell By” dates through May 6, 2015.
- Consumer Health Info
Feb 11, 2015 - If you or someone in your household is allergic to milk, take heed: a recent study by FDA found that many of the dark chocolate products contain milk. And you canÃ¢â‚¬â„¢t always tell thatÃ¢â‚¬â„¢s the case simply by reading the food label.Jan 27, 2015 - Scientists are working to develop breakthrough therapies for pancreatic cancer, one of the deadliest cancers that affects both men and women. FDA has approved three treatments for advanced pancreatic cancer to help patients live longer.Jan 15, 2015 - Have an overactive bladder? FDA-approved treatments can help adults of any age control their symptoms and live an active life.Jan 5, 2015 - Many so-called miracle weight loss supplements and foods (including teas and coffees) don't live up to their claims. Worse, they can cause serious harm.Dec 23, 2014 - In much of the Northern Hemisphere, this is prime time for colds, influenza (flu), and other respiratory illnesses. While contagious viruses are active year-round, fall and winter are when we're all most vulnerable to them.Dec 19, 2014 - When operated unsafely, or without certain controls, the highly-concentrated light from lasersâ€”even those in toysâ€”can be dangerous, causing serious eye injuries and even blindness. FDA has issued draft guidance on the safety of toy laser products to protect children from harm.Dec 17, 2014 - Got questions about the foods, drugs and other issues involving your pet? FDA's Center for Veterinary Medicine (CVM) may be able to answer them. Read these seven frequently asked questions, and CVM's answers.Dec 16, 2014 - FDA officials are concerned over the marketing of fetal keepsake videos and over-the-counter Doppler ultrasound heartbeat monitors.Dec 12, 2014 - FDA warns consumers about an undeclared ingredient in a coffee drink, a risk of infection from a children’s supplement, and a sexual enhancement product that contains the active ingredient found in Viagra.Dec 3, 2014 - The Food and Drug Administration is helping women and their health care providers to learn more about the effects of medicines during pregnancy and breastfeeding.Dec 3, 2014 - Pregnant women who are prescribed a drug may worry of the potential impact on their developing fetuses. FDAÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s pregnancy registries can help ease that worry.Dec 2, 2014 - FDA is working hard to make sure you have the information you need to make informed decisions about your health.Dec 1, 2014 - Continuous glucose monitoring technology alerts patients to low and high blood sugar levels, including how quickly they are changing.Nov 17, 2014 - Sometimes a cold is just a cold. What can worried parents do when their babies and young children have a cold? FDA has some advice and tips.Nov 14, 2014 - FDA warns consumers about baby wipes that may contain bacteria, undeclared drugs found in a product sold as a dietary supplement with weight loss claims, and a pain reliever packaging mix up.Nov 14, 2014 - To implement the section of the Affordable Care Act related to nutrition labeling, FDA is publishing final rules that require calorie information to be listed on menus and menu boards, and near self-serve foods and foods on display in certain chain restaurants, food stores, entertainment venues, and vending machines. The goal is to help consumers make more informed choices about what they eat away from home.Nov 12, 2014 - Food and Drug Administration analysts and entomologists investigate product samples and protect consumers from spoiled and contaminated food.Nov 5, 2014 - This guide provides tips and a quick-reference chart to help you report a problem to FDA.Nov 3, 2014 - If you eat meat or drink milk, you want to know: Are the veterinary drugs used in food-producing animals entering your diet? And if they are, are the amounts safe for human consumption? Those are some of the concerns of FDA's Division of Residue Chemistry.Oct 31, 2014 - Got a question about a medicine? FDA's Division of Drug Information can answer it.
- News Releases
Mar 4, 2015 - The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.Mar 4, 2015 - Today, the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages.Feb 25, 2015 - The U.S. Food and Drug Administration today approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.Feb 23, 2015 - The U.S. Food and Drug Administration today approved Farydak (panobinostat) for the treatment of patients with multiple myeloma.Feb 20, 2015 - The U.S. Food and Drug Administration today approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent.Feb 19, 2015 - The U.S. Food and Drug Administration today authorized for marketing 23andMe’s Bloom Syndrome carrier test, a direct-to-consumer (DTC) genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder.Feb 13, 2015 - Today, the U.S. Food and Drug Administration issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians.Feb 13, 2015 - The U.S. Food and Drug Administration today granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease).Feb 12, 2015 - A San Francisco, California-based food company, Fong Kee Tofu Co., Inc., and its owners, Jen Ying Fong, Suny Fong, and Yan Hui Fan, have agreed not to process or distribute food until it has been demonstrated to the U.S. Food and Drug Administration that its facility and practices comply with federal food safety requirements.Feb 12, 2015 - The U.S. Food and Drug Administration today allowed marketing of the Eclipse System for the treatment of fecal incontinence (FI) in adult women.Feb 12, 2015 - The FDA today cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation. This expanded use allows healthcare providers to use one or two negative Xpert MTB/RIF Assay test results to help them determine whether a patient showing signs and symptoms of pulmonary TB should continue to be kept in a hospital airborne isolation room.Feb 9, 2015 - The U.S. Food and Drug Administration today cleared for marketing the ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS), for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries. It is the first device designed to access the carotid arteries through an incision in the neck, instead of the groin, and uses a blood flow reversal system to capture pieces of the blockage dislodged during the procedure.Feb 6, 2015 - The U.S. Food and Drug Administration today expanded the approved use for Lucentis (ranibizumab injection) 0.3 mg to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME).Feb 4, 2015 - A federal judge from the U.S. District Court for the District of New Hampshire has entered a consent decree of permanent injunction against Maquet Holding B.V. & Co. KG (Maquet), and two of the company’s officers, Heinz Jacqui and Gail Christie, for repeatedly failing to correct violations at three of its companies, which are also named on the consent decree: Atrium Medical Corporation (Atrium) in Hudson, New Hampshire; Maquet Cardiovascular, LLC (Maquet CV) in Wayne, New Jersey; and Maquet Cardiopulmonary AG (Maquet CP) in Rastatt and Hechingen, Germany.Feb 4, 2015 - The U.S. Food and Drug Administration (FDA) today approved TissuGlu, the first tissue adhesive approved for internal use.Feb 3, 2015 - The U.S. Food and Drug Administration today granted accelerated approval to Ibrance (palbociclib) to treat advanced (metastatic) breast cancer.FDA seeks $4.9 billion for FY 2016 to implement the FDA Food Safety Modernization Act and improve t...Feb 2, 2015 - The U.S. Food and Drug Administration is requesting a budget of $4.9 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2016 budget – a nine percent increase over the enacted budget for FY 2015. The overall request includes $147.7 million in budget authority for initiatives tied to several key areas, including the implementation of the FDA Food Safety Modernization Act and the management of critical medical products issues.Jan 30, 2015 - The U.S. Food and Drug Administration today expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults. The drug is the first FDA-approved medication to treat this condition.Jan 30, 2015 - At the request of the U.S. Food and Drug Administration, a federal judge from the U.S. District Court for the Central District of California today entered a consent decree of permanent injunction against Laclede, Inc. of Rancho Dominguez, California, and its president, Michael A. Pellico. Laclede is the manufacturer of Luvena Prebiotic products.Jan 29, 2015 - The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for previously treated patients with Waldenström’s macroglobulinemia (WM), a rare form of cancer that begins in the body’s immune system. The drug received a breakthrough therapy designation for this use.