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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)
Oct 17, 2014 - JFC International Inc. of Los Angeles, CA is voluntarily recalling all lot codes of its 3-pack Hapi Pudding with a net weight of 8.46 ounces (UPC 11152 13417), because they may contain undeclared milk. People who have allergies to milk run the risk of a serious or life-threatening allergic reaction if they consume the products.AMS Health Sciences, LLC Issues Voluntary Recall of Saba Shark Cartilage Complex, 60 Capsule Bottle...Oct 17, 2014 - AMS Health Sciences, LLC is notifying the public that it is recalling 2014 bottles of Saba Shark Cartilage Complex due to possible contamination of 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.Hospira Announces Voluntary Nationwide Recall Of One Lot Of 1% Lidocaine HCI Injection, USP 10 MG P...Oct 17, 2014 - Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary recall of one lot of 1% Lidocaine HCI for Injection, USP, 10 mg per mL, 30 mL Single-dose, Preservative-Free (NDC 0409-4279-02; Lot 40-316-DK, Expiry 1APRIL2016) to the user level due to a confirmed customer report of particulate in a single unit. Hospira has identified the particulate as a human hair, embedded in and attached to a pinched area of the stopper.Oct 17, 2014 - Oasis Brands, Inc. of Miami, FL is recalling select lots of various Lacteos Santa Martha products with Best by dates of 07/01/14 through 12/31/14, because the products has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.United Natural Trading LLC dba/ Woodstock Farms Manufacturing Issues Allergy Alert for Undeclared P...Oct 17, 2014 - United Natural Trading LLC dba/ Woodstock Farms Manufacturing, Edison, New Jersey are recalling 22lb. bulk cases only (Lot# YOUI03) and Market Basket 12oz. tubs only (Lot# 14248) because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.Oct 17, 2014 - Out of an abundance of caution, Publix Super Markets is issuing a voluntary recall for Publix Asian Mix because the product contains peanuts that are not declared on the packaging.New Hope Mills Issues Allergy Alert on Undeclared Soy in New Hope Mills Gluten Free Chia Pancake an...Oct 17, 2014 - New Hope Mills Manufacturing of Auburn, NY is recalling all Gluten Free Chia Pancake and Waffle Mix because it may contain undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.Hospira Announces Voluntary Nationwide Recall Of Certain Lots of Several Lifecare Products Due To P...Oct 14, 2014 - Hospira, Inc. (NYSE: HSP), today announced the voluntary recall of certain lots of several products in its LifeCare™ line of flexible intravenous solutions due to the potential for leakage.Oct 13, 2014 - Real Foods of Seattle, LLC, (WA) is initiating a voluntary recall of 96 units of “Mexican Cheddar Dip” product due to an undeclared allergen.Oct 13, 2014 - SunBurst Foods, Goldsboro NC is voluntarily recalling all of its SunBurst, Fresh Bites and Private labeled products which are currently in the market because these products have the potential to be contaminated with Listeria monocytogenesCovidien Initiates Voluntary Field Safety Alert for Medi-Trace Cadence and Kendall Multi-function D...Oct 11, 2014 - Covidien today announced that it has notified customers of a voluntary Field Safety Alert for certain Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillators.Oct 10, 2014 - California Olive and Vine, LLC of Sutter, CA is taking precautionary measures and voluntarily recalling Pumpkin Seed Pesto because of irregular lab results.Oct 9, 2014 - LOTTE Confectionery Co., Ltd. (manufacturer), 21-5ka, Yangpyung-dong, Youngdeunpo-gu, Seoul, Korea, is recalling its 1.41 ounce (40g) and 5.64 ounce (160g) packages of Lotte Waffles because they contain undeclared egg ingredients.Oregon Compounding Centers, Inc. Issues Voluntary Recall of Unexpired Sterile Products in Oregon an...Oct 9, 2014 - Oregon Compounding Centers, Inc., dba Creative Compounds, is voluntarily recalling certain unexpired human and veterinary sterile products to the consumer level due to lack of sterility assuranceOct 8, 2014 - Oasis Brands, Inc of Miami, FL is recalling Cuajada en Hoja 12oz with Best By 10/01/14- 10/08/14 and 10/18/14, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.Hospira Issues a Voluntary Nationwide Recall of One Lot of Vancomycin Hydrochloride for Injection U...Oct 8, 2014 - Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary nationwide user-level recall of one lot of Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g Vancomycin (Sterile Powder), NDC 0409-6533-01, Lot 35-315-DD with expiration date of 01NOV 2015. This action is because the product may have experienced temperature excursions during shipment to a customer and then was further distributed by the customer.Oct 7, 2014 - HAR Maspeth Corp. of Maspeth, NY, is recalling its 2 ounce and 4 ounce packages of Jinga Ã¢â‚¬Å“Pan Fried AnchoviesÃ¢â‚¬ï¿½ due to contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems.J&b European Distribution Inc. Issues Allergy Alert For Undeclared Milk In Kupiec Rice Cakes With D...Oct 7, 2014 - J&B EUROPEAN DISTRIBUTION INC. of BROOKLYN, NY is recalling 40 cases of KUPIEC brand RICE CAKES WITH DARK CHOCOLATE, NET WT. 3.1 OZ. (90g), UPC # 5 906747 171742, because they may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product.SAM Medical Products Implements Voluntary Recall of its Accessory (Axilla) Strap for the SAM Juncti...Oct 7, 2014 - SAM Medical Products announced today that it has begun notifying customers of a voluntary recall to address a potential issue with a clip used to secure the accessory strap used for the Axilla application of the SAM Junctional Tourniquet (SJT).Markpol Distributors Inc. Issues Allergy Alert on Undeclared Milk in Kupiec Rice Cakes with Dark Ch...Oct 3, 2014 - Markpol Distributors Inc. of Wood Dale, Illinois is recalling Kupiec Rice Cakes with Dark Chocolate because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
- Consumer Health Info
Oct 16, 2014 - The Food and Drug Administration's Office of International Programs has offices around the world. Learn how the agency is working with Mexico.Oct 15, 2014 - At FDA's National Center for Toxicological Research, investigators are researching pediatric brain function; and they've developed an innovative tool.Oct 14, 2014 - FDA is collaborating with patients, members of academia, and the pharmaceutical industry to encourage the development of new treatments for sickle cell disease (SCD).Oct 14, 2014 - FDA warns consumers about the risk of lead poisoning from cold therapy, an updated drug alert on the lack of sterility assurance, and the recall of mole medication amidst safety concerns.Oct 7, 2014 - Antihistamines and other OTC drugs can impair your ability to drive and operate machinery.Sep 30, 2014 - Scientists at FDA are studying the next generation of screening and diagnostic devices, some of which borrow from the world of entertainment and videogames. In the future, those 3D images and displays may help doctors find hidden tumors and better diagnose cancers.Sep 24, 2014 - After a decade of progress FDA still keeping people informed about prostate cancer therapies.Sep 18, 2014 - In addition to supporting FDA's evaluation of new medications for animals, FDA's work with animals helps protect the U.S. food supply to keep people healthy.Sep 17, 2014 - FDA warns consumers about undeclared drugs found in appetite control pills, an undeclared drug ingredient found in a sexual enhancement product.Sep 17, 2014 - In the past year, FDA has given adults new options for treating migraines by allowing the marketing of two prescription devices for such headaches. Some patients don't tolerate migraine drugs well, and these devices can provide an alternative they didn't have before.Sep 10, 2014 - Today is World Youth Suicide Prevention Day. Learn how FDA-approved antidepressants are helping depressed kids.Sep 8, 2014 - FDA has approved the OraQuick In-Home HIV Test, a rapid home-use HIV test kit that enables users to collect fluid samples and get the test results themselves in 20-40 minutes. The goal is for a greater number of people at risk for HIV to be tested, by increasing accessibility to rapid in-home tests that assure anonymity.Sep 4, 2014 - At the National Center for Toxicological Research, scientists are working, in collaboration with the Center for Drug Evaluation and Research, on new ways to use MRI machines to help study damage to the brain from certain drugs and environmental chemicals.Sep 2, 2014 - Just as FDA reviews drugs for humans for safety and effectiveness before they can go on the market, the agency does the same for treatments for animals. Learn how FDA brings new oncology treatments to market and questions to ask your vet about your dogÃ¢â‚¬â„¢s cancer diagnosis.Aug 28, 2014 - As scientists learn more about psoriasis, more therapeutic options are becoming available for patients with this skin disease. Understanding how psoriasis develops enables them to target different steps in the disease pathway to broaden the types of treatments available.Aug 27, 2014 - Whether your child is an athlete who needs extra calories for that after-school game, or a teenager trying to maintain a healthy weight, here are four tips for making a nutritious lunch.Aug 26, 2014 - Had an issue with a medicine, medical device, or food product and did not know who to notify? FDA's MedWatch is here to help.Aug 25, 2014 - Some companies are marketing untested, unproven, and possibly dangerous products that claim to prevent, treat, or cure concussions and other traumatic brain injuries.Aug 19, 2014 - FDA warns consumers to avoid a weight loss supplement that contains undeclared drug ingredients; lack of sterility and particles in an anesthetic.Aug 15, 2014 - What is lupin, and why should you care: The answers to these two questions could have an important impact on your health.
- News Releases
Oct 17, 2014 - The U.S. Food and Drug Administration today approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.Oct 15, 2014 - The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).Oct 15, 2014 - The U.S. Food and Drug Administration today approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF).Oct 14, 2014 - A federal judge from the U.S. District Court for the Southern District of Ohio entered a consent decree for permanent injunction against Ascend Laboratories, LLC, of Montvale, New Jersey on Oct. 10. The U.S. Department of Justice filed the consent decree on behalf of the U.S. Food and Drug Administration.Oct 14, 2014 - The U.S. Food and Drug Administration today allowed marketing of the inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults who cannot contract the muscles necessary to push urine out of the bladder (impaired detrusor contractility or IDC).Oct 10, 2014 - The U.S. Food and Drug Administration today approved Lumason (sulfur hexafluoride lipid microsphere) for patients whose ultrasound image of the heart (echocardiograms) are hard to see with ultrasound waves.Oct 10, 2014 - The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.Oct 10, 2014 - The U.S. Food and Drug Administration today approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB). This is the first drug-coated balloon used to re-open arteries in the thigh (superficial femoral arteries) and knee (popliteal arteries) when narrowed or blocked as a result of peripheral artery disease (PAD).Oct 10, 2014 - The U.S. Food and Drug Administration today approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy.Oct 3, 2014 - The U.S. Food and Drug Administration is seeking a permanent injunction to stop Pharmaceutical Innovations Inc., and its principal officer, Gilbert Buchalter, from manufacturing, marketing, selling, and distributing medical products until they come into compliance with all applicable FDA requirements.Oct 1, 2014 - To strengthen the safety of medical devices, the U.S. Food and Drug Administration today finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.Sep 30, 2014 - The U.S. Food and Drug Administration today announced it has awarded 15 grants totaling more than $19 million to boost the development of medical device, drug, and biological products for patients with rare diseases, with at least a quarter of the funding going to studies focused solely on pediatrics.Sep 25, 2014 - U.S. Marshals at the request of the U.S. Food and Drug Administration today seized more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc. in Van Nuys, California.Sep 25, 2014 - The National Institutes of Health and the U.S. Food and Drug Administration will receive a top national award for the year’s most outstanding intellectual property licensing deal, for technology transfer of a pioneering, low-cost meningitis vaccine launched in sub-Saharan Africa. The 2014 Deals of Distinction Award will be presented to the two federal agencies and their collaborators by the Licensing Executives Society at the society’s 50th annual meeting, Oct. 5-8 in San Francisco.Sep 24, 2014 - Today the U.S. Food and Drug Administration cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized. This is the first blood glucose monitoring system (BGMS) cleared by FDA for use in these patients.Sep 23, 2014 - The U.S. Food and Drug Administration is asking for potential breakthrough ideas on how to find disease-causing organisms in food – especially Salmonella in fresh produce.FDA allows marketing of the first test to identify five yeast pathogens directly from a blood sampleSep 22, 2014 - The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/or Candida krusei.FDA releases updated proposals to improve food safety and help prevent foodborne illness in respons...Sep 19, 2014 - Based on extensive outreach and public comment, the U.S. Food and Drug Administration today proposed revisions to four proposed rules designed to help prevent food-borne illness. When finalized, the proposed rules will implement portions of the FDA Food Safety Modernization Act (FSMA), which aims to strengthen food safety by shifting the focus to preventing food safety problems rather than responding to problems after the fact.Sep 18, 2014 - The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.Sep 16, 2014 - The U.S. Food and Drug Administration today approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.