Drug Search

May 22, 2012 - A team of researchers led by the U.S. Food and Drug Administration has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions.

May 22, 2012 - U.S. Marshals, acting at the request of the Food and Drug Administration, have seized HybriSil (methylprednisolone acetate 1% percentin silicone gel), an unapproved new drug marketed by Crescendo Therapeutics, L.L.C., of Vista, Calif.

May 17, 2012 - The U.S. Food and Drug Administration today approved generic versions of the blood thinning drug Plavix (clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.

May 15, 2012 - The U.S. Food and Drug Administration today expanded the use for the FilmArray Respiratory Panel, the first test that can simultaneously detect both viral and bacterial causes of respiratory infection from a single sample.

May 10, 2012 - The U.S. Food and Drug Administration is alerting health care professionals and patients about injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency (CCSVI).

May 9, 2012 - Today, the U.S. Food and Drug Administration announced that it is seeking public comment on a proposal encouraging manufacturers to consider the safety of children in the design of new X-ray imaging devices. In the draft guidance, FDA is recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients.

May 3, 2012 - The U.S. Food and Drug Administration issued its final rule on sterility testing, amending the requirements for most licensed biological products.

May 1, 2012 - On April 30, the U.S. Food and Drug Administration today allowed marketing of the first surgical instrument set that can be assembled and disassembled inside the body during surgery. The Percutaneous Surgical Set is intended to be used during minimally invasive laparoscopic abdominal surgery, in which a camera and surgical instruments are inserted through one or more small incisions (surgical cuts into body tissue) in the abdomen.

May 1, 2012 - The U.S. Food and Drug Administration today approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder.

Apr 30, 2012 - The U.S. Food and Drug Administration today approved Levaquin (levofloxacin) to treat patients with plague, a rare and potentially deadly bacterial infection. The agency also approved the drug to reduce the risk of getting plague after exposure to Yersinia pestis, the bacterium that causes the disease.

Apr 27, 2012 - The U.S. Food and Drug Administration today issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA.

Apr 27, 2012 - The U.S. Food and Drug Administration today approved Stendra (avanafil), a new drug to treat erectile dysfunction.

Apr 26, 2012 - The U.S. Food and Drug Administration today approved Votrient (pazopanib) to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy. Soft tissue sarcoma is a cancer that begins in the muscle, fat, fibrous tissue, and other tissues.

Apr 26, 2012 - The U.S. Food and Drug Administration today approved Afinitor (everolimus), the first drug approved specifically to treat non-cancerous kidney tumors (renal angiomyolipomas) not requiring immediate surgery in patients with tuberous sclerosis complex (TSC).

Apr 26, 2012 - This week, the U.S. Department of Agriculture (USDA) confirmed that a dairy cow in California tested positive for atypical bovine spongiform encephalopathy (BSE, or "mad cow" disease). The USDA also confirmed the cow did not enter the animal feed or human food supply. The U.S. Food and Drug Administration is working with federal and state authorities to further investigate this case.

Apr 23, 2012 - The U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D. today released the agency’s “Global Engagement Report” [INSERT HYPERLINK], detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency.

Apr 21, 2012 - A strengthened and modernized postmarket drug safety program has resulted in a substantial improvement in the U.S. Food and Drug Administration’s oversight of drugs once they reach the American public, according to a new report released today by the agency’s Center for Drug Evaluation and Research (CDER). The report, “Advances in FDA’s Safety Program for Marketed Drugs,” describes new scientific tools and enhanced capabilities that give the same priority to postmarket drug safety monitoring as to premarket drug review.

Apr 20, 2012 - Two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries were issued today by the U.S. Food and Drug Administration.

Apr 18, 2012 - U.S. Marshals, acting at the request of the Food and Drug Administration, today seized Other-Sonic Generic Ultrasound Transmission Gel located at Pharmaceutical Innovations Inc. in Newark, N.J. after an FDA analysis found that product samples contained dangerous bacteria.

Apr 13, 2012 - • Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif. is voluntarily recalling 58,828 lbs of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a ground product. • The product is not available for sale to individual consumers, but may have been used to make sushi, sashimi, ceviche and similar dishes available in restaurants and grocery stores. • The company name and Nakaochi Scrape AA or AAA were printed on boxes of the product when it was initially sold to distributors. However, the boxes may have been broken into smaller lots for further sale and may not be available to the end retailer or consumer. Therefore, the tuna may not be readily identifiable by retail outlets or by consumers as being from the implicated lots. • The Nakaochi Scrape AA and AAA from MMI was sold through distributors to restaurants and grocery stores that make sushi, and has been linked to an outbreak of Salmonella Bareilly, which has caused 116 illnesses in 20 states and the District of Columbia to date. Of the reported illnesses, there have been 12 hospitalizations, and no deaths. • Many of the people who became ill reported eating raw tuna in sushi as “spicy tuna.” • If you purchase “spicy tuna” or other sushi, sashimi, ceviche, or similar dishes that might contain Nakaochi Scrape from a restaurant or grocery store, check with the establishment to make sure that it does not contain raw recalled product from Moon Marine USA Corporation, also known as MMI. When in doubt, don’t eat it. • Consumers who think they might have become ill from eating possibly contaminated raw Nakaochi Scrape should consult their health care providers.

May 23, 2012 - Harris Teeter is recalling HT Traders Sorbet in the following flavors: Lemon, Raspberry, Mango, Coconut and Orange, due to possible undeclared milk protein. This recall affects the below products:

May 23, 2012 - Indonesianfoodmart.com of Rockville, MD, is recalling all packages of "Tempeh Starter Yeast" because they have 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.

May 22, 2012 - Taylor Farms Retail, Inc. is initiating a voluntary recall of Organic Baby Spinach with the potential to be contaminated with Salmonella following a random test conducted on a finished package of spinach by USDA.

May 22, 2012 - Pacific Coast Fruit Company, Portland, Oregon is voluntarily recalling multiple types of bagged processed salads based on the potential contamination of 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.

May 21, 2012 - Diamond Pet Foods is expanding a voluntary recall to include its Diamond Naturals Small Breed Adult Dog Lamb & Rice Formula dry dog food manufactured on Aug. 26, 2011 due to potential exposure to Salmonella. No illnesses have been reported.

May 20, 2012 - River Ranch Fresh Foods, LLC of Salinas, CA is expanding its voluntary recall of retail and foodservice bagged salads, because they have the potential of being contaminated with Listeria monocytogenes.

May 19, 2012 - Gills Onions, LLC of Oxnard, CA is initiating a voluntary recall, 2,360 pounds, of diced red onions with lot code 51RDA1A2119 and use-by-dates May 14, 15 and 17, 2012 because it may be contaminated by Listeria monocytogenes. The product is beyond its use-by-date, no illnesses have been reported in connection with this recall, and no other Gills Onions product is affected by this recall.

May 18, 2012 - Caribe Produce LTD Co. of McAllen, TX, is recalling 286 cases of Papaya Maradol, Caribeña Brand papayas packed in 35 lb. cartons marked with the brand “ Caribeña “ and “ Product of Mexico” stamped on the side. The papayas are sold individually, and each one bears a label which states “3112 CARIBENA Papaya MARADOL PRODUCT OF MEXICO

May 18, 2012 - River Ranch Fresh Foods, LLC of Salinas, CA is initiating a voluntary recall of retail and foodservice bagged salads,because they have the potential of being contaminated with Listeria monocytogenes following routine random retail salad finished product tests conducted in the marketplace by the Food & Drug Administration.

May 18, 2012 - WEST COAST NUTRITIONALS, LTD is conducting a voluntary recalling all lots of FIRMINITE, EXTRA STRENGTH INSTANT HOT ROD, AND LIBIDRON capsules to the consumer level. An FDA lab analysis of FIRMINITE distributed by West Coast Nutritionals was found to contain undeclared Tadalafil.

May 18, 2012 - Santos Agency, Inc. has initiated a recall of Santos Brand products i.e. various kinds of flours, legumes and spices because they may contain undeclared peanuts and wheat.

May 16, 2012 - Bakery El Monte Sinai Corp., located at 100 A North Franklin Street in Hempstead, New York 11550, is recalling rainbow cake because it may contain undeclared eggs.

May 12, 2012 - Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary user level recall of one lot of Hydromorphone Injection, USP, 1 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1283-31, due to two reported complaints of a single Carpuject containing more than the 1 mL labeled fill volume. Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed.

May 11, 2012 - Nestlé Purina PetCare (NPP) is voluntarily recalling one specific lot of its Purina Veterinary Diets® OM Overweight Management canned cat food, available through veterinarians in the U.S. and Canada. This precautionary measure is being taken in response to one consumer complaint received by FDA.

May 11, 2012 - On May 4, 2012, Natural Balance Pet Foods announced a voluntary recall of certain dry pet food formulas manufactured by Diamond Pet Foods at their Gaston, South Carolina facility. Link to original press release: http://www.fda.gov/Safety/Recalls/ucm303042.htm

May 11, 2012 - Whole Foods Market is recalling its variety cupcake six-packs sold in stores in Northern California because some of the products contain undeclared walnuts. One illness has been reported to date, and people who have allergies to walnuts run the risk of serious or life-threatening allergic reaction if they consume these products.

May 11, 2012 - Jonlly Fruits Inc. de Bayamon PR, hace un llamado al cosumidor de sus productos Jonlly Fruit Y Natural Tropic; China, Acerola, Uva, Parcha, Frutas, Limón, Toronja, Guanabana, Guava Piña, China Light, Mandarina, China Zanahoria. Porque prodria contener un tipo de alergeno no declarado en la etiqueta, específicamente; Partilly Hydrogenated Coconut oil, Corn Syrup Solids, Sodium Caseinate (a Milk Derivative), Xanthan Gum, Mono-And Diglycerides, Dipotassium Phosphate, Contains 2% or less of Sodium Silicoaluminate and Soy Lecithin.

May 11, 2012 - Jonlly Fruits Inc., Bayamón, PR, is alerting consumers about their brands Jonlly Fruit and Natural Tropic: China (Orange), Acerola (Wild Cherry), Uva (Grape), Parcha (Passion Fruit), Fruta (Fruit Punch), Limón (Lemon), Toronja (Grapefruit), Guava-Piña (Guava-Pineapple), Guanábana (Soursop), China Light (Orange Light), Mandarin (Mandarina), and China-Zanahoria (Orange-Carrot) because it may contain undeclared sodium caseinate (a milk derivative). People who are allergic or are severely sensitive to milk run the risk of a serious or a life-threatening allergic reaction if they consume these products.

May 9, 2012 - Moon Fishery (India) Pvt. Ltd., the Manufacturer of the Yellow Fin Tuna Nakaochi Scrape that was recently recalled by a U.S. Distributor, is also recalling its 22 pound cases of "Tuna Strips" Product of India AA or AAA GRADE because they have 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, nausea, vomiting and abdominal pain.

May 8, 2012 - Solid Gold Health Products for Pets, Inc., El Cajon, California, announced a voluntary recall of one batch of WolfCub Large Breed Puppy Food and one batch of Solid Gold WolfKing Large Breed Adult Dog, both with a Best Before date of December 30, 2012, and an "X" in the 11th digit of the date code.

May 22, 2012 - A new FDA database pulls the science on drug labels for kids into one place.

May 21, 2012 - In this webinar, FDA audiologist Sue-Chen Peng, Ph.D., offers consumers basic information on hearing loss and hearing aids.

May 18, 2012 - Michelle Yeboah of FDA’s Office of Minority Health tells how the agency is addressing health disparities among minority populations in America.

May 15, 2012 - FDA warns about a contaminated ultrasound gel, and a higher risk of blood clots with some birth control pills.

May 3, 2012 - During the outbreak of Salmonella Bareilly tied to spicy tuna sushi, , FDA's urgent-response team shifted into high gear.

Apr 29, 2012 - This page contains links to all past Consumer Update Analytics web pages.

Apr 23, 2012 - New "Global Engagement" report opens a window of FDA's work around the world to guarantee the safety of imported foods, medical products and other regulated goods.

Apr 20, 2012 - The Food and Drug Administration (FDA) is continuing a dialogue on nanotechnology by publishing draft guidelines on the use of nanomaterials in cosmetics and substances added to foods.

Apr 19, 2012 - FDA is warning that improper use, storage and disposal of the fentanyl patch, a potent pain medication, can be deadly to children who swallow it or apply it to their own skin.

Apr 19, 2012 - The Food and Drug Administration (FDA) announces safety alerts and reviews for some widely used medications, skin creams and baby food.

Apr 4, 2012 - Learn about these and other safety alerts at http://www.fda.gov/Safety/MedWatch.

Apr 4, 2012 - After a series of safety scares involving Chinese exports, the Food and Drug Administration's China office has trained nearly 1,600 Chinese manufacturers and regulators on U.S. safety standards. They hope the training will head off future problems.

Apr 2, 2012 - FDA is working with the Institute for Safe Medication Practices (ISMP) to protect consumers from medication errors, which are preventable mistakes in labeling, packaging, prescribing, dispensing, and order communication.

Mar 30, 2012 - The Tobacco Control Act created a path that companies may use to bring products to the market that are less harmful or reduce the risk of tobacco-related disease.

Mar 30, 2012 - FDA establishes a list of harmful or potentially harmful chemicals in tobacco products and smoke, and requires tobacco companies to report how much of these chemicals are in their products.

Mar 30, 2012 - The assessment by the Food and Drug Administration is that scientific evidence does not suggest that the very low levels of human exposure to BPA through the diet are unsafe.

Mar 6, 2012 - Federal health officials are warning consumers not to use skin creams, beauty and antiseptic soaps, or lotions that might contain mercury after products with the toxic metal turned up in at least seven states.

Feb 28, 2012 - The Food and Drug Administration (FDA) announces important safety changes for statins, the popular cholesterol-lowering drugs.

Feb 27, 2012 - To help rare disease patients become advocates for themselves and others, the Food and Drug Administration is holding a FDA Rare Disease Patient Advocacy Day.�

Feb 23, 2012 - The Food and Drug Administration and the National Institutes of Health have launched a nationwide study of smokers and nonsmokers to understand more about tobacco use.