Oct 31, 2009 - FDA has approved four vaccines for immunization against the 2009 H1N1 influenza virus. Three of them are inactivated virus vaccines for injection, manufactured by CSL Limited, Sanofi Pasteur, Inc, and Novartis Vaccines and Diagnostics Limited. The ...
Oct 31, 2009 - Covidien is recalling certain lots of its End-Tidal CO2 Detectors, the Pedi-Cap and Pedi-Cap 6, because a modification made by the manufacturer may occlude the patient's airway. This could make it difficult to manually ventilate a patient, and lead ...
Oct 31, 2009 - Tibotec Therapeutics is notifying healthcare professionals of severe and potentially life-threatening skin reactions from Intelence (etravirine), an antiretroviral drug used in HIV combination therapy. Intelence has been associated with cases of Ste...
Oct 31, 2009 - Philips Healthcare has alerted healthcare professionals about the possibility of inaccurate fetal heart rate readings from the company's Avalon fetal monitors, which use ultrasound to measure fetal heart rate. Inaccurate readings could result in unn...
Oct 31, 2009 - Healthcare professionals have been notified by the manufacturers of CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid) that these drugs, in combination with other immunosuppressive agents, have been associated with cases of pure red ce...
Oct 31, 2009 - The device company ConMed Linvatec is recalling certain surgical handpieces and cables. The handpieces are battery-powered devices used with drills, blades and other cutting devices during surgical procedures.
This action affects certain model an...
Oct 31, 2009 - FDA is requiring stronger warnings about an increased risk of lymphoma and other cancers in children and adolescents who are treated with drugs that block tumor necrosis factor. TNF blockers include Remicade (infliximab), Enbrel (etancercept), Humir...
Oct 31, 2009 - Smiths Medical is recalling certain Portex uncuffed tracheal tubes in pediatric sizes. The recall affects several models of 2.5, 3.0 and 3.5 mm tubes manufactured before September 2009.
The internal diameter of some of these tracheal tubes is sli...
Oct 31, 2009 - Emergency response help buttons are often worn by seniors to call for help in an emergency. The Philips Lifeline emergency button that is worn around the neck, may pose a choking hazard if the cord becomes accidentally entangled, and this can result...
Nov 24, 2009 - Timco Worldwide Inc. is recalling a limited number of its Large Seedless Watermelons because they have the potential to be contaminated with Salmonella. No illnesses have been reported to date in connection with this occurrence.
Nov 23, 2009 - Unilever United States, Inc., of Englewood Cliffs, NJ, in cooperation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling certain Shedd’s Country Crock® chilled side-dish products because they may contain undeclared sulfites. 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.
Nov 20, 2009 - Five Crowns Marketing, Brawley, California is issuing this release today voluntarily recalling cantaloupes packed under the Majesty label because of a potential health risk due to possible contamination of Salmonella. No illnesses have been reported to date, and the company is working with FDA to inform consumers of this recall.
Nov 20, 2009 - Superior Foods Co., Grand Rapids, MI. is recalling Lemon Pepper Marinated Catfish because it may contain undeclared soy and FD&C Yellow #5. In addition, Superior Foods Co. is recalling Cajun Style Marinated Catfish because it may contain soy and milk that is not declared on the label. People who have an allergy or severe sensitivity to these run the risk of serious or life-threatening allergic reaction if they consume these products.
Nov 20, 2009 - Service Smoked Fish Corp. of Brooklyn, NY, is recalling specific “Use-By” dates and lot codes of Brooklyn’s BEST brand SMOKED NOVA SALMON because they have 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 possibly 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.
Nov 20, 2009 - – Fresh & Easy Neighborhood Market is voluntarily recalling some fresh&easy™ “Pumpkin Cheesecake Pies” (40 oz.) because they may contain undeclared pecans. Individuals who have allergies to pecans run the risk of serious or life-threatening allergic reaction if they consume these products.
Nov 19, 2009 - The Procter & Gamble Company (NYSE:PG) announced today it is voluntarily recalling three lots of its Vicks Sinex nasal spray in three countries: the United States, Germany and the United Kingdom. The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany.
Nov 19, 2009 - Nassau Candy Distributors of Hicksville, New York, is voluntarily recalling possibly unlabeled pegable snack tubs because they contain the following undeclared allergens; Tree Nuts {Almonds}, Soy and Milk and may contain the following undeclared allergens Peanuts, other Tree Nuts {brazil nuts, walnuts, filberts, hazelnuts, pecans, pistachios, macadamia nuts, cashews and coconut}. People who have an allergy to any of these specific types of allergens run the risk of serious or life-threatening allergic reaction if they consume these products...
Nov 17, 2009 - Snacks on Racks, Inc. of Parkville, Missouri is recalling products from their line of Gourmet Snacks Packs because they may contain undeclared milk, peanuts, tree nuts, soy, egg, sulfites or wheat. People who have an allergy or severe sensitivity to milk, peanuts, tree nuts, egg, sulfites, soy or wheat run the risk of serious or life-threatening allergic reaction if they consume these products. The complete list of recalled products are listed at the end of this press release.
Nov 17, 2009 - RockHard Laboratories announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplement sold under the name RockHard Weekend (RHW) specific to the following Lot Numbers:
Blister Pack: T12 705 08 (exp: 10/11) / T12 705 09 (exp: 3/12, 8/12)
3ct Bottle: R417 0509 (exp: 09/12)
8ct Bottle: T237-0509 (exp: 06/12)
RockHard Laboratories is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that voluntary lab analysis found that RHW, specific to the above lot numbers, contains sulfoaildenfil, an analogue of Sildenfil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making RockHard Weekend an unapproved drug. The active drug ingredient is not listed on the product label.
Nov 17, 2009 - – Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII) has announced a voluntary recall of all lots of the ViperSheathTM Sheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use. CSI initiated the nationwide recall on November 2, 2009.
Nov 14, 2009 - Cardiac Science Corporation [NASDAQ: CSCX] is initiating a voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt. Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death. These AEDs have electronic components which may fail and the failure may not be detected by the device’s periodic self-tests.
Nov 13, 2009 - IDS Sports announced today that it is
conducting a voluntary nationwide recall of five of the company’s dietary supplement products sold
under the following names: Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and
Ripped Tabs TR.
The Food And Drug Administration (FDA) has notified IDS Sports that the recalled products contain the
following undeclared substances, which FDA considers to be steroids: “Madol,” “Turinabol,”
“Superdrol,” and/or “Androstenedione.”
Nov 13, 2009 - Today, ConAgra Foods, in cooperation with the U.S. Food and Drug Administration (FDA) is voluntarily recalling a limited number of 15 oz. tubs of Blue Bonnet Spread that were inadvertently mispackaged—the lid is for regular Blue Bonnet Spread and the tub portion describes the product as Blue Bonnet Light Spread. The product inside of the tub is regular Blue Bonnet Spread. As a result, the product tubs do not declare the allergen whey (milk), as an ingredient.
Nov 13, 2009 - Herbal Products, Inc. has been informed by the Food and Drug Administration (FDA) that Pai You Guo, a weight loss dietary supplement, sold and marketed by the firm contains undeclared drug ingredients. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss; and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States.
Nov 12, 2009 - Reports of loss of device height, which may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for surgery to modify the implanted device.
Nov 9, 2009 - Hospira, Inc. (NYSE: HSP), a global specialty pharmaceutical and medication delivery company, is voluntarily recalling 85 lots of Liposyn™ II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80 because some of the containers may contain particulate matter. The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process.
Nov 6, 2009 - Jelly Belly Candy Company is recalling 7.5-ounce cylinder-style packages of 49 Flavors Jelly Belly jelly beans because the package is incorrectly labeled. The mislabeled packages failed to list peanut butter and peanut flour in the ingredient statement...
Nov 5, 2009 - The U.S. Food and Drug Administration is issuing this health alert to warn consumers not to use Pig Ears and Beef Hooves pet treats manufactured by Pet Carousel because the products may be contaminated with Salmonella. The products were distributed nationwide in both bulk and retail packaging for sale in pet food and retail chain stores. Pet Carousel is based in Sanger, Calif.
Nov 24, 2009 - In this Consumer Update video, FDA Product Safety Expert Deborah Autor, J.D., helps explain the agency's warning, issued July 28, 2009, to stop using body building products that claim to contain steroids or steroid-like substances.
Nov 23, 2009 - The posting of FDA staff in overseas regions is a key part of the agency's strategy for expanding oversight of imported food and medical products.
Oct 27, 2009 - FDA has stepped up its campaign to inform consumers of—and protect them against—potential harm associated with unapproved products claiming to diagnose, prevent, or otherwise act against the H1N1 flu virus.
Oct 27, 2009 - Medical X-rays are an important tool for diagnosing and treating diseases, but they pose a small risk from radiation. This FDA Consumer Update video includes information on what you can do to reduce the risk.
Oct 22, 2009 - On October 15, 2009, the U.S. Food and Drug Administration (FDA) launched a study of the impact of LASIK on patients' quality of life, and issued warning letters to 17 LASIK surgery centers that release patients the same day as their surgery.
Nov 24, 2009 - The U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Sharkco Seafood International Inc., located in Venice, La. The injunction is intended to stop the seafood processing company from distributing scombrotoxin-forming fish in interstate commerce. Consumption of scombrotoxin-forming fish that are not properly preserved or refrigerated can result in scombroid food poisoning, a foodborne illness that results from eating spoiled or decayed fish. Scombrotoxin-forming fish most commonly include mackerel, sardines, tuna, bluefish, and mahi mahi.
Nov 20, 2009 - MICHAEL RALPH WORLEY, 43, of Camano Island, Washington, and DONALD ALAN PEPIN, 55, of Jupiter, Florida, were charged late yesterday by a federal grand jury in Seattle, Washington, with Conspiracy to Commit Wire Fraud and Engage in Interstate Transportation of Stolen Property and six counts of Wire Fraud. WORLEY is also charged with two counts of Interstate Transportation of Stolen Goods, while PEPIN is charged with two counts of Receipt of Stolen Goods. The conspiracy involved the theft of diabetic supplies, including insulin, from an Everett, Washington, Pharmacy. The insulin and other supplies were then sold to PEPIN for distribution to the public. Both men will be summoned to appear in federal court in Seattle for arraignment.
Nov 19, 2009 - The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against William F. Nickle of North East, Md., for allegedly selling veal calves for human consumption that contained illegal drug residues in edible tissues.
Nov 19, 2009 - The U.S. Food and Drug Administration today completed a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products.
Nov 18, 2009 - On Nov. 16, 2009, Judge Marvin J. Garbis of the United States District Court for the District of Maryland entered a Consent Decree of Permanent Injunction (Decree) against Old Carolina Farm and its owner, Francis Roderick, of Ijamsville, Md. The Decree prohibits the defendants from selling animals for slaughter for human consumption until they have implemented record keeping systems that will identify and track animals that have been treated with drugs.
Nov 18, 2009 - Patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel), the U.S. Food and Drug Administration warned on Nov. 17.
Nov 17, 2009 - The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles.
Nov 17, 2009 - The U.S. Food and Drug Administration (FDA) and Everyday Health today announced a collaboration that will expand the delivery of the agency’s vital consumer health information to the 30 million unique users who visit Everyday Health each month. This joint effort reflects FDA's emphasis on using innovative, technology-based strategies to carry out its mission of protecting and promoting the public health.
Nov 16, 2009 - The U.S. Food and Drug Administration announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus. The vaccine is manufactured by ID Biomedical Corp. of Quebec, Canada, owned by GlaxoSmithKline PLC.
Nov 13, 2009 - The Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) today released a report from the Institute of Food Technologists (IFT), which recommends clear objectives be set for all users of a simpler, globally accepted food supply chain that can benefit from existing commercial systems.
Nov 13, 2009 - The U.S. Food and Drug Administration today approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot.
Nov 13, 2009 - Several weeks ago, the FDA announced its intent to change, by summer 2011, its policy regarding the post-harvest processing of raw Gulf Coast oysters harvested in the warmer months. The intent of this change in policy, which would affect about 25% of the total annual harvest, would be to substantially reduce the number of Americans who suffer severe and painful illness and death from the Vibrio vulnificus bacteria. The FDA's announced change in policy was modeled on a successful California initiative that was implemented in 2003.
Nov 13, 2009 - The U.S. Food and Drug Administration today cleared for marketing the Platelet PGD Test System, the first rapid test for the detection of bacterial contamination in pooled platelets derived from whole blood.
Nov 13, 2009 - The Food and Drug Administration today notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.
Nov 13, 2009 - The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against seafood processor Haifa Smoked Fish Inc. of Jamaica, N.Y., and two of its top officers for violations of the Federal Food, Drug and Cosmetic Act.
Nov 12, 2009 - Toan Le, 51, and Hang Ho, 41, a married couple residing in Burien, Washington, pleaded guilty today in U.S. District Court in Seattle in connection with their attempt to import and use a cosmetic device that had not been approved for use in the U.S. by the Food and Drug Administration. LE pleaded guilty to providing an Illegal Gratuity to Public Official and HO pleaded guilty to Introduction or Delivery for Introduction Into Interstate Commerce of Adulterated Device. When sentenced by U.S. District Judge Ricardo S. Martinez, LE faces up to two years in prison and HO faces up to one year in prison.
Nov 12, 2009 - The U.S. Food and Drug Administration has approved the use of the CSL Limited’s 2009 H1N1 influenza vaccine to include children ages 6 months and older. This vaccine was previously approved only for use in adults, ages 18 years and older.
Nov 11, 2009 - Ming Yan, who operates a computer store in North Providence, has pleaded guilty to causing the misbranding of the prescription drug sildenafil citrate, which is marketed as Viagara, and to copyright infringement. Immigration and FDA agents seized counterfeit sildenafil citrate pills and more than 1,000 pirated movie DVDs from Yan’s store and home in March 2008.
Nov 10, 2009 - Dr. Margaret Hamburg, Commissioner of Food and Drugs, today sent a letter to America’s doctors thanking them for their efforts during the 2009 H1N1 influenza outbreak and providing information on the safety of the 2009 H1N1 vaccines.
Nov 9, 2009 - Cutaneous T-cell lymphoma affects about 1,500 Americans annually
The U.S. Food and Drug Administration has approved Istodax (romidepsin), an injectable medication, for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma (CTCL).