The FDA warned four companies that they must stop marketing unapproved codeine sulfate tablets. These drugs, commonly called narcotics, are widely used to treat pain. These particular products have not received FDA approval and the agency has no evidence that they are safe and effective. Another manufacturer, Roxane Laboratories, markets FDA-approved codeine sulfate tablets and is able to meet the demand for the drug. The FDA does not anticipate a supply problem for codeine sulfate tablets.

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The U.S. Department of Justice, on behalf of the FDA, has filed a complaint for permanent injunction against Rel's Foods Inc. (Rel's) seeking to stop the company from manufacturing, producing and selling adulterated food products. Rel's prepares, processes and distributes a variety of ready-to-eat sandwiches to convenience stores, deli markets, liquor stores, mini-marts and gas stations in Nevada and California. The government's complaint alleges that Rel's has an extensive history of operating under unsanitary conditions.

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The FDA ordered manufacturers of certain types of pedicle screw systems, called dynamic stabilization systems, to conduct postmarket surveillance studies to collect clinical data on potential safety issues, including fusion rates and frequency of additional surgeries. Dynamic stabilization systems are used in spinal surgery; some are intended to provide stabilizing support to the spinal column during bone fusion. There are not enough clinical data to determine whether these dynamic stabilization systems provide enough spinal stability to allow for complete spinal fusion. The system components may loosen, bend or break over time. If fusion does not occur, a patient's condition could worsen and require additional surgery.

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The FDA alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common anti-clotting drug. To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug's unit dose. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.

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The FDA announced a ban on cigarettes with flavors characterizing fruit, candy or clove. The ban, authorized by the new Family Smoking Prevention and Tobacco Control Act, is part of a national effort by the FDA to reduce smoking in America. The ban highlights the importance of reducing the number of children who start to smoke, and who become addicted to dangerous tobacco products. Flavors make cigarettes and other tobacco products more appealing to youth. Studies have shown that 17-year-old smokers are three times as likely to use flavored cigarettes as smokers over the age of 25.

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The FDA cautioned users of personal emergency response buttons worn around the neck of a potential choking hazard associated with this product. There have been at least six reports between 1998 and 2009 of serious injury or death, from choking after the cord on the Philips Lifeline Personal Help Button became entangled on other objects worn around the neck. The device is used primarily by seniors living independently, who feel they are at risk for falls or other medical emergencies. The button is intentionally designed to not break away when tugged, which prevents the button from accidentally falling off. However, because it does not break away, there is a risk of choking, including the possibility of serious injury or death. Letters are being sent to 750,000 customers and labeling of this product has been changed to include a warning against the potential choking hazard.

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The FDA is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA's authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting health care professionals to the new boxed warning for this product. Promethazine should not be administered into an artery or under the skin because of the risk of severe tissue injury, including gangrene, the boxed warning says. There is also a risk that the drug can leach out from the vein during intravenous administration and cause serious damage to the surrounding tissue. As a result of these risks, the preferred route of administration is injecting the drug deep into the muscle.

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The FDA announced that Care-Tech Laboratories Inc. and its principal officers, John C. Brereton and Sherry L. Brereton, have signed a consent decree, agreeing to stop the illegal manufacture, marketing and distribution of over-the-counter (OTC) antimicrobial drugs used to treat and prevent infection. Inspectors found that Care-Tech violated many provisions of the FDA's current good manufacturing practice (cGMP) regulations. The products also do not conform to any applicable regulations for OTC drug products and have not undergone an FDA review, and therefore are considered unapproved drug products.

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The FDA is reminding the public that stolen vials of the long-acting insulin Levemir still may be on the market. Evidence suggests that the stolen insulin was not stored and handled properly, and may be dangerous. The FDA has received multiple reports of patients who suffered adverse events due to poor glucose control levels after using a vial from one of the stolen lots. When the FDA first alerted the public to the theft in June, it reported that three lots of Levemir totaling 129,000 vials had been stolen in North Carolina. So far only about two percent of the total amount stolen has been recovered.

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The FDA is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical and the over-the-counter medication Alli. Between 1999 and 2008, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 required hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the US. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness and stomach pain.

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The FDA issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen. The products contain ibuprofen in combination with a variety of other active ingredients. These products, marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed. Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products.

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The FDA is advising health care practitioners and patients against using certain glucose monitoring technologies that employ a specific test strip when patients are also receiving therapeutic products containing non-glucose sugars. The non-glucose sugars in some therapeutic products can falsely elevate glucose results, which may prompt excessive insulin administration. These therapeutic products are mostly used in patients with serious medical conditions. The glucose test strips in question contain glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ), the chemical that reacts with the non-glucose sugars (maltose, galactose and xylose) contained in some therapeutic products. This combination can produce a falsely high test result. Most GDH-PQQ devices are used in health care facilities.

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At the request of the FDA, U.S. Marshals seized tuna salad sandwiches and other food products from Bearden Sandwich Company Inc., doing business as Southern Belle Sandwich Company. The seized products violate the Federal Food, Drug, and Cosmetic Act because each has been prepared, packed and held under unsanitary conditions. The products may have become contaminated with filth or rendered injurious to the public's health. In addition, the tuna fish salad sandwiches were processed under conditions that violate Seafood Hazard Analysis Critical Control Point (HACCP) regulations. Recent FDA inspections found evidence of widespread and active rodent and insect infestation, filthy conditions and poor employee practices. The company distributes products to convenience and retail stores in southern Louisiana; Mobile and Montgomery, AL; and Crestview, FL.

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The FDA is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers. The warnings, which include an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, the inflammatory bowel disorder, Crohn's disease and other inflammatory diseases. In addition, the FDA is working with manufacturers to explore new ways to further define the risk of cancer in children and adolescents who use these drugs.

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The FDA announced an update to a previous safety alert on four botulinum toxin drug products. All four products now have boxed warnings on their labels and have developed Medication Guides for patients, as directed by the agency in April 2009. The boxed warning cautions that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include potentially life-threatening swallowing and breathing difficulties and even death. These symptoms have mostly been reported in children with cerebral palsy being treated with botulinum toxin for muscle spasticity, a use of the drugs that has not been approved by FDA. Symptoms have also been reported in adults treated both for approved and unapproved uses.

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U.S. Marshals, at the request of the FDA, have seized all skin sanitizers and skin protectants, including ingredients and components, at Clarcon Biological Chemistry Laboratory's Roy, Utah facility. The FDA is also warning consumers not to use any Clarcon products because they contain harmful bacteria and are promoted as antimicrobial agents that claim to treat open wounds, damaged skin and protect against infectious diseases. Clarcon voluntarily recalled the affected products in June 2009, following an FDA inspection that revealed high levels of potentially disease-causing bacteria. The inspection also uncovered serious deviations from the FDA's Current Good Manufacturing Practice regulations, including poor practices that permitted the contamination.

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The FDA announced a consent decree of permanent injunction that prohibits Teva Animal Health Inc., its president, and two principals from its parent company, from manufacturing and distributing adulterated veterinary drugs. The injunction, once entered by the court, will prevent the defendants from manufacturing and distributing veterinary drugs until they achieve compliance with current Good Manufacturing Practice (cGMP) and obtain FDA approval. During inspections between 2007 and 2009, the FDA found significant cGMP violations at Teva Animal Health's facilities.

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The FDA issued a Public Health Advisory (PHA) warning consumers to stop using bodybuilding products that are represented as containing steroids or steroid-like substances. The agency also issued a Warning Letter to American Cellular Laboratories Inc. for marketing and distributing bodybuilding products containing synthetic steroid substances. These products are unapproved and misbranded drugs. The PHA also advises consumers to stop taking bodybuilding products from any manufacturer that claim to contain steroid-like substances or to enhance or diminish androgen-, estrogen-, or progestin-like effects in the body.

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The FDA announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze. These battery-operated devices generally contain cartridges filled with nicotine, flavor and other chemicals. The electronic cigarette turns nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user. These products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. They are available in different flavors, such as chocolate and mint, which may appeal to young people.

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Luv N' Care Ltd. of Monroe, La., is initiating a nationwide recall of gel-filled teethers with the brand names "Nuby," "Cottontails" and "Playschool," because the liquid inside the gel-filled teethers has been found to contain Bacillus subtilis and Bacillus circulans bacteria in the gel. Although these bacteria generally do not cause illness in adults, infants and children with weakened immune systems can experience stomach pain, vomiting, diarrhea or more serious diseases, if the teether becomes punctured and the liquid gel is ingested. Consumers who have teethers with specific brand names and UPC codes should immediately stop using them and discard or return them to the place of purchase for a full refund.

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The FDA announced that it is conducting a safety review of Xolair, a drug used to treat certain adults and adolescents with moderate-to-severe persistent asthma. Reviewers are looking for a possible association between patients who use Xolair and an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke. The possible association has been identified based on interim results from an ongoing study of Xolair.

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The FDA will require manufacturers of some immunosuppressant drugs used in kidney (renal) transplantation to update their labeling to reflect an increased risk of infections. The labeling changes are being required based on review of reported adverse events. The labeling changes must reflect the reported increased risk for opportunistic infections, including activation of latent viral infections. These include BK virus-associated nephropathy, which can mainly affect kidney transplant patients. Such infections may lead to serious outcomes, including kidney graft loss.

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The U.S. Department of Justice, on behalf of the FDA, has filed a complaint for permanent injunction against Quality Formulation Laboratories, Inc., American Sports Nutrition Inc., Sports Nutrition International LLC and Mohamed S. Desoky, who oversees all three companies. The companies manufacture dietary supplements and protein powders and distribute them throughout the United States. The companies also export powder mixes and dietary supplements for sale by private customers. The complaint alleges that the companies have failed to follow current Good Manufacturing Practice (GMP) by manufacturing and storing food under filthy conditions that may cause major food allergens to enter products not intended to contain them. The complaint also alleges that the companies failed to disclose major food allergens on the product labels and have other labeling problems. FDA investigators also discovered live and dead rodents and rodent urine, feces and gnaw holes on bags of product.

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The U.S. Department of Justice, on behalf of the FDA, filed a complaint seeking injunctive relief against Peregrina Cheese, Inc. of Brooklyn, N.Y. and two of its officers. The company prepares and processes a variety of cheeses, sour cream, flan and gelatin products and distributes them to specialty grocery stores in Pennsylvania and the New York City area. The government's complaint alleges that the company has an extensive history of operating under unsanitary conditions and producing cheese contaminated with Listeria monocytogenes. Listeria is a foodborne pathogen. Listeriosis, the illness caused by Listeria monocytogenes, can cause fatal infections in young children, frail or older people and others with weakened immune systems. No illnesses have been reported to date from Peregrina Cheese products. However, if individuals have eaten the products and are experiencing any of the symptoms listed above, they should contact their health care professional.

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The FDA is taking actions to reduce the risk of overdose in patients using pain medications such as Darvon and Darvocet that contain propoxyphene. The actions were taken because of data linking propoxyphene and fatal overdoses. The agency is requiring manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose. These manufacturers will also be required to provide a medication guide to patients stressing the importance of using the drugs as directed. In addition, the FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses.

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The FDA is warning consumers not to buy or use Hardcore Energize Bullet or New Whey liquid products sold in test tube-like vials due to suspected product tampering. The products are being recalled. No one is known to have been hurt. The FDA advises consumers who may have purchased these products not to consume them. Health care professionals and consumers are encouraged to report serious adverse effects or product quality problems with the use of Hardcore Energize Bullet and New Whey liquid products to the FDA's MedWatch Adverse Event Reporting program.

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The FDA announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility and suicidal thoughts when taking these drugs. Similar information on mental health events will be required for bupropion marketed as the antidepressant Wellbutrin and for generic versions of bupropion. These drugs already carry a Boxed Warning for suicidal behavior in treating psychiatric disorders.

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The FDA announced that it has found E. coli O157:H7 (a bacterium that can cause serious foodborne illness) in a sample of prepackaged Nestlé Toll House refrigerated cookie dough currently under recall by the manufacturer and marketer, Nestlé USA. The contaminated sample was collected at Nestlé's facility in Danville, Va. The FDA and the CDC had previously warned consumers not to eat any varieties of prepackaged Nestlé Toll House refrigerated cookie dough due to the risk of E. coli contamination. As of Thursday, June 25, the CDC reports that 69 persons from 29 states have been infected with the outbreak strain. Thirty-four persons have been hospitalized. No one has died. Nestlé USA has fully cooperated with the FDA and CDC investigation and has recalled all of its prepackaged Nestlé Toll House refrigerated cookie dough products.

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Plainview Milk Products Cooperative is voluntarily recalling instant nonfat dried milk, whey protein, fruit stabilizers and gums (thickening agents) that it has manufactured over the past two years, because they might be contaminated with Salmonella. The company sells these products to other industry customers, including distributors and manufacturers, who may have incorporated them into their own products. None of Plainview's products were sold directly to the public. During an investigation of the Plainview facility, FDA found that some of the equipment was contaminated with Salmonella. At this time, the Centers for Disease Control and Prevention has not linked any human illnesses to potentially contaminated products from the Plainview facility.

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U.S. Marshals, at the request of the FDA, seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company's Michigan facilities in Detroit, Farmington Hills and Wixom. The seizure also includes ingredients held at these same facilities.This action follows Caraco's continued failure to meet the FDA's current Good Manufacturing Practice (cGMP) requirements, which assure the quality of manufactured drugs. The FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, choline magnesium trisalicylate oral tablets, which are commonly used as pain relievers. The FDA recommends in the event of a shortage, that health care providers consider alternative treatments that are safe and effective.

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The FDA is warning consumers not to eat California Prime Produce and Orange County Orchards brands of pistachios repacked by Orca Distribution West Inc. Orca received and repacked pistachios recalled by Setton Pistachio of Terra Bella Inc. The pistachios may 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. The FDA visited Orca as part of its audit checks to follow up on Setton Pistachio's recall. The products were distributed to retail locations in airports and hotels nationwide.

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The FDA and the Centers for Disease Control and Prevention are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes foodborne illness). The FDA advises that if consumers have any prepackaged, refrigerated Nestle Toll House cookie dough products in their home that they throw them away. Cooking the dough is not recommended because consumers might get the bacteria on their hands and on other cooking surfaces. Retailers, restaurateurs and personnel at other food-service operations should not sell or serve any Nestle Toll House prepackaged, refrigerated cookie dough products subject to the recall.

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The FDA warned consumers on May 1, 2009 about products related to the 2009 H1N1 flu virus offered on the Internet. The products involved are those that are promoted and marketed to diagnose, mitigate, prevent, treat or cure the 2009 H1N1 flu virus but are not approved, cleared or authorized by the FDA. The agency advised operators of offending Web sites that they must take immediate action to ensure that they are not marketing products that make such claims The FDA has issued more than 50 warning letters to offending Web sites. More than 66 percent of these Web sites have since removed the offending claims and/or products.

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The FDA has issued a Safety Communication about an ongoing review of stimulant medications used in children with ADHD. According to a study published in the American Journal of Psychiatry, there may be an association between the stimulant medications for ADHD and sudden cardiac death in healthy children. But the FDA says that because of the study's limitations, parents should not stop a child's medication based on the study. The FDA recommends that parents should discuss concerns about the use of these drugs with the prescribing health care professional.

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The FDA has learned that some stolen vials of the long-acting insulin Levemir, made by Novo Nordisk, Inc., have reappeared and are being sold in the U.S. market. Three lots, or a total of 129,000 vials of this product, were stolen. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use. The FDA has received one report of a patient who suffered an adverse event due to poor control of glucose levels after using a vial from one of these three lots.

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The FDA provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. The FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast. Leukotrienes are chemicals the body releases in response to an inflammatory stimulus, such as when a person breathes in an allergen.

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The FDA is alerting patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate. In rare cases, pacemaker-dependent patients may experience serious injury or even death. About 21,000 of the 1.7 million Kappa or Sigma pacemakers implanted in patients throughout the world are affected by this recall, most of which have been in patients for five years or longer.

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The FDA announced Clarcon Biological Chemistry Laboratory Inc. of Roy, Utah, is voluntarily recalling some skin sanitizers and skin protectants marketed under several different brand names because of high levels of disease-causing bacteria found in the product during a recent inspection. The FDA is warning consumers to not use any Clarcon products. Consumers should throw these products away in household refuse. Analyses of several samples of over-the-counter topical antimicrobial skin sanitizer and skin protectant products revealed high levels of various bacteria, including that can cause opportunistic infections of the skin and underlying tissues.

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The FDA has warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil for the treatment of Graves' disease. Propylthiouracil is considered second-line drug therapy, except in certain patients who are allergic to, or intolerant of, methimazole. Graves' disease is an autoimmune disorder that leads to overactivity of the thyroid gland.

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The FDA is advising consumers to stop using certain cosmetic "Face Paint" items that are labeled as being distributed by Oriental Trading Co., Omaha, Neb., due to adverse event reports of skin reactions in children. A cluster of adverse events in children exposed to various colors of these face paints has been reported. All exposures occurred on the same day at an organized event and included rashes, itchiness, burning sensation and swelling where the face paints were applied. Significant microbial contamination was indicated in most of the products in testing by an FDA laboratory.

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The U.S. District Court for the Eastern District of Michigan, Southern Division, today entered a consent decree that condemns and forfeits to the United States for destruction about $1.3 million worth of dietary supplements. At the request of the FDA, U.S. Marshals seized more than 23,300 bottles of three dietary supplement products distributed by LG Sciences LLC. Based on laboratory tests, the FDA determined that the products contain one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to assure that the ingredients do not present a significant or unreasonable risk of illness or injury.

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The FDA announced that it is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products' labels. The agency is requiring this action after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure). In most of the cases, users of these products failed to follow appropriate use instructions, resulting in direct contact between treated skin and the child. The gels are approved for use in men who either no longer produce testosterone or produce it in very low amounts.

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The FDA is warning consumers to immediately stop using Hydroxycut products. Some Hydroxycut products are associated with serious liver injuries. The manufacturer has agreed to recall Hydroxycut products from the market. The FDA has received 23 reports of serious liver problems ranging from jaundice and elevated enzymes to damage requiring liver transplant. Other health problems reported include seizures, heart problems and muscle damage.

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The FDA and the Federal Trade Commission are alerting the public to be wary of Internet sites and other promotions for products that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus ("swine flu"). The agencies are also advising operators of offending Web sites that they must correct and/or remove promotions of these fraudulent products or face enforcement action. Many of these deceptive products are being sold over the Internet via illegitimate Web sites. Operators of these web sites take advantage of the public's concerns about H1N1 influenza and their desire to protect themselves and their families. Consumers are urged to contact their health care providers or legitimate medical supply services if they have questions or concerns about medical products or personal protective equipment.

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The FDA announced that safety label changes, including a boxed warning and a Risk Evaluation and Mitigation Strategy (REMS), are necessary for all botulinum toxin products. The agency said it took the action because of reports that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Symptoms have included unexpected loss of strength, muscle weakness, hoarseness, trouble speaking, swallowing or breathing, loss of bladder control, vision problems and drooping eyelids. These symptoms have been reported mostly in children with cerebral palsy being treated with the products for muscle spasticity, which is an unapproved use of the drugs. Symptoms have also been reported in adults treated both for approved and unapproved uses.

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The FDA issued a final rule that requires manufacturers of OTC pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these drugs. Products covered by the FDA action include acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen and ketoprofen. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers. Manufacturers must now ensure that the active ingredients of these drugs are prominently displayed on drug labels on both packaging and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

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The FDA and the Centers for Disease Control and Prevention (CDC) recommended that consumers not eat raw alfalfa sprouts, including sprout blends containing alfalfa sprouts, because the product has been linked to Salmonella serotype Saintpaul contamination. The problem may be linked to contamination of alfalfa sprouts seeds. Because suspect lots of seeds may be sold around the country and may account for majority of the alfalfa seeds being used by sprout growers, and cases of illness are spread across multiple states, FDA and CDC are issuing this general advisory. FDA will work with the alfalfa sprout industry to help identify which seeds and alfalfa sprouts are not connected with this contamination, so that this advisory can be changed as quickly as possible.

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The FDA is alerting the public to the expanded, voluntary recall of sauces, oils and oil blends sold under the Uncle Chen and Lian How brands. The expanded recall is based on the investigation into the ongoing food borne illness outbreak of Salmonella Rissen. It is in addition to the recall announced last month by the company of its dry spice products. To date, 57 cases of illness caused by Salmonella Rissen have been reported, mostly in the western region of the country.

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The FDA announced that it had obtained a permanent injunction barring Neilgen Pharmaceuticals Inc., its parent company, Advent Pharmaceuticals, Inc., and two of their officers, Bharat Patel and Pragna Patel, from manufacturing and distributing any unapproved, adulterated or misbranded drugs. Both Neilgen, which does business as Unigen Pharmaceuticals Inc., and Advent are contract manufacturers and distributors of more than 50 different unapproved drug products. The products primarily include prescription cough and cold products. The unapproved drugs manufactured by these companies have not undergone the FDA's drug approval process, so their safety and effectiveness have not been established and the FDA has not reviewed the adequacy and accuracy of the directions for use and warnings on the labeling.

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Genentech, Inc. announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, Raptiva will no longer be available in the United States. Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva on how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to other alternative therapies for psoriasis.

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U.S. Marshals, at the request of the FDA, executed an inspection warrant at Westco Fruit and Nuts Inc. The company did not provide access to distribution documents and declined to recall products after an FDA request. Regulated companies are required by law to grant FDA entry for inspection, as well as provide access to distribution records. The FDA does not have authority to compel companies to recall food products. The company received peanuts and peanut product from the Peanut Corporation of America (PCA), which recalled products in January due to concerns of Salmonella contamination. Despite PCA's effort to remove the affected product from the market and FDA's intervention, Westco/Westcott has refused to recall its products.

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The FDA announced that manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type. Devices found by the FDA to be of high risk to consumers will need to undergo the agency's most stringent pre-market review process. These 25 device types were marketed in the U.S. prior to the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976. That law authorized the FDA to review new medical devices. This announcement is the first step toward completing the review of Class III device types predating the 1976 law.

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The FDA is warning consumers not to eat Strubs Norwegian Style Sliced Smoked Steelhead Salmon in 300 gram packages because of potential contamination with the bacterium Listeria monocytogenes. L. monocytogenes is a foodborne pathogen that can cause serious illness and death. The smoked steelhead salmon was imported from Canada, and 13 cartons were sold to three kosher retail stores in New York and Maryland. The FDA urges consumers who have purchased the Strubs product to dispose of the product in a safe manner and wash their hands thoroughly after handling the product. The contamination was discovered by the FDA and the Canadian Food Inspection Agency during routine testing.

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The FDA is alerting the public to a voluntary recall by Union International Food Company of the company's dry spice products. The recall is based on an investigation of an ongoing outbreak of Salmonella Rissen. This investigation is being conducted along with state health officials in California, Oregon, Nevada, Washington and the U.S. Centers for Disease Control and Prevention (CDC). The dry spices being recalled were sold under the brand names "Lian How" and "Uncle Chen." At this time, the distribution of products appears confined to the western region of the country.

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The FDA has warned nine companies to stop manufacturing 14 unapproved narcotic drugs that are marketed in several dosage forms and are widely used to treat pain. The FDA's warning letters notified the companies they may be subject to enforcement action if they do not stop manufacturing and distributing these unapproved products. These products include high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone.

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The FDA and the California Department of Public Health (CDPH) are investigating Salmonella contamination in pistachio products sold by Setton Pistachio of Terra Bella Inc. The company has stopped distributing all processed pistachios and will issue a voluntary recall involving approximately 1 million pounds of its products. The pistachios were used as ingredients in many foods, so this recall will likely impact several products and require additional pistachio product recalls.

The contamination involves many strains of Salmonella. Salmonella can cause serious and sometimes fatal infections in young children, seniors or people with compromised health. Several illnesses have been reported by consumers that may be associated with the pistachios. It is not yet known whether any of the Salmonella strains found in the pistachio products are linked to an outbreak. The FDA is conducting genetic testing of the samples to pursue all links.

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The FDA is advising retailers and food service operators not to offer for sale oysters harvested between Feb. 24 and March 17, 2009, from Mississippi Area 2C, located in the Mississippi Sound portion of the Gulf of Mexico near Pass Christian, Miss. Further, consumers are advised not to eat such oysters. Consumers who are uncertain about the origin of oysters they have should contact the place of purchase to determine if the oysters are from the affected area. The FDA is investigating an outbreak of norovirus illnesses associated with the oysters. Norovirus is a foodborne pathogen that can cause acute gastroenteritis in humans.

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The FDA is warning consumers not to consume any peanuts or peanut-derived products sold by Westco Fruit and Nuts Inc. (Westco/Westcott) due to possible Salmonella contamination. Peanuts in such products may have been distributed by the Peanut Corporation of America (PCA), which recalled the peanuts because of concern about Salmonella contamination. PCA's Blakely, Ga., facility is a source of the current Salmonella Typhimurium outbreak and led to PCA's recall of the peanuts. Between Nov. 19 and Dec. 30, 2008, Westco/Westcott received three shipments of Oil Roasted Salted Redskin Jumbo Peanuts from PCA's Blakely, Ga., facility.

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The FDA is expanding its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients. The FDA has identified additional weight loss products and new undeclared active pharmaceutical ingredients (fenproporex, fluoxetine, furosemide, and cetilistat). The list now includes 72 products. These products, some of which are marketed as dietary supplements, are promoted and sold on various Web sites, in some retail stores and beauty salons. Some claim to be "natural" or to contain only "herbal" ingredients, but actually contain potentially harmful ingredients not listed on the products' labels or in promotional advertisements. These products have not been approved by the FDA and are illegal.

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The FDA is warning consumers not to eat Queso Fresco Fresh Cheese Mexican style soft cheese (two specific lots) or any Queso Cotija Molido Mexican style grated cheese manufactured and distributed by Peregrina Cheese Corp. These products could be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in pregnant women, young children, frail or elderly people and others with weakened immune systems. Consumers who may have recently eaten these products and have these symptoms should contact their doctor.

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The FDA announced that Del Rey Tortilleria Inc., its president, and two general managers have entered into a consent decree of permanent injunction that prevents the company from manufacturing and distributing soft-shell flour tortillas until it obtains FDA approval. The FDA's enforcement action follows the company's extensive history of violating the Agency's current Good Manufacturing Practice (cGMP) requirements for food.

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The FDA announced that certain adhesive patches that deliver medication through the skin, if worn while undergoing magnetic resonance imaging scans or MRIs, can cause skin burns. The patches of concern include both brand name and generic products and ones purchased over the counter without a prescription. Patients should tell their MRI facility that they are using a patch when they call to schedule their appointment and should repeat this information when filling out their health history questionnaire after arriving for their appointment.

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The FDA announced a Consent Decree of permanent injunction enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs. The injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval. It will remain in place until the defendants sustain continuous compliance with FDA's current Good Manufacturing Practice (cGMP) and new drug approval requirements for six years.

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The FDA announced that manufacturers of metoclopramide must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. Metoclopramide is available in a variety of formulations including tablets, syrups and injections. More than two million Americans use these products.

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The FDA announced that a facility owned by Ranbaxy Laboratories falsified data and test results in approved and pending drug applications. The facility, Paonta Sahib, has been under an FDA Import Alert since September 2008. To date, the FDA has no evidence that these drugs do not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products. In the meantime, the FDA recommends that patients not disrupt their drug therapy because this could jeopardize their health. Individuals who are concerned about their medications should talk with their health care professional.

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At the request of the FDA, the U.S. District Court for the District of Minnesota on Feb. 17, 2009, entered an order of permanent injunction against seafood processor Captain's Select Seafood Inc., Minneapolis, MN, and its co-owners Carolyn M. Young and William J. Young. The defendants are charged with repeatedly violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA's Hazard Analysis Critical Control Point (HACCP) regulations for seafood processors. The court held that the evidence presented by the FDA showed a lengthy and undisputed history of violations from 2004 through at least early 2008.

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The FDA announced that Cardinal Health 303 Inc., formerly known as Alaris Medical Systems Inc., and three of its top executives have signed an amended consent decree to correct violations of current Good Manufacturing Practice (cGMP) requirements in the company's infusion pumps. Under the terms of the amended consent decree, Cardinal 303 agrees to comply with the cGMP requirements and Quality System (QS) regulations in the designing, manufacturing, processing, packing, repacking, labeling, holding or distributing of its infusion pumps. Cardinal 303 also must retain an independent expert consultant to inspect of all of its infusion pump facilities and recall procedures, and certify to the FDA that corrections have been made.

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The FDA is warning consumers not to take Venom HYPERDRIVE 3.0, a product sold as a dietary supplement and containing sibutramine. Sibutramine, a controlled substance with risks for abuse or addiction, is a potent drug that poses potential safety risks. The product was sold via distributors and in retail stores nationwide as well as in Canada, Poland, Sweden, Hungary, South Africa, the Netherlands, Australia, France and the United Kingdom.

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The FDA is investigating the source of a Salmonella Typhimurium outbreak that has been closely linked to peanut butter products. Sources have been traced to a plant owned by Peanut Corporation of America (PCA). The plant manufactures peanut butter and peanut paste. Both products are distributed to food manufacturers for use as an ingredient in commercial products. PCA also makes peanut butter that is distributed for institutional use in settings such as long-term care facilities and cafeterias. Major national brands of peanut butter in jars are not affected by the PCA recall.

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The FDA issued a Public Health Advisory to alert consumers, patients, health care professionals and caregivers about potentially serious and life-threatening side effects from the improper use of skin numbing products. The products, also known as topical anesthetics, are available by prescription and over-the-counter (OTC). Skin numbing products are used to desensitize nerve endings that lie near the surface of the skin, causing a numbness of the skin. These topical anesthetics contain drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel. When applied to the skin surface, they can be absorbed into the blood stream. Improper use may cause life-threatening side effects, such as irregular heartbeat, seizures, breathing difficulties, coma or even death.

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The FDA announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO). On Oct. 30, 2008, AMO voluntarily recalled all 4,439 units of Healon D lot no. UD30654 of Healon D, due to complaints of inflammation after eye surgery, including Toxic Anterior Segment Syndrome (TASS). However, as of December 3, 2008, AMO had retrieved only 964 units of the 1,450 that had been distributed in the United States. AMO received 66 adverse event reports associated with the recalled products. Tests of this lot revealed elevated levels of endotoxin, which has been associated with post-operative intraocular inflammation and TASS.

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The FDA is expanding its nationwide alert to consumers about tainted weight loss pills that contain undeclared, active pharmaceutical ingredients. The FDA has warned consumers not to purchase or consume 73 different products marketed for weight loss. An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent) and bumetanide (a diuretic).

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The FDA announced that the District Court for the Western District of Missouri entered a Consent Decree on Dec. 15, 2008, prohibiting Milbank Mills, an animal feed mill, from manufacturing, processing, or distributing medicated animal feed. Milbank Mills and its officers Edward P. Milbank and Darrell L. Allen, face these restrictions until they comply with current Good Manufacturing Practice (cGMP) requirements for medicated animal feeds.

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The FDA recommended that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular events as a heart attack. The recommendation is part of a new guidance for industry that applies to all diabetes drugs currently under development. Patients with diabetes have a two- to four-times greater risk of heart disease than their non-diabetic counterparts, and none of the currently approved antidiabetic therapies has been convincingly proven to reduce that risk.

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The FDA announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy. The FDA is also requiring the manufacturers to submit for each of these products a Risk Evaluation and Mitigation Strategy, including a Medication Guide for patients. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed.

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The FDA announced a Class 1 recall for two unapproved and uncleared devices, whose manufacturers claimed could treat various medical conditions. A Class 1 recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death. The manufacturers claimed their devices treated conditions ranging from cancer to migraines. The FDA is concerned that based upon the original health claims made by the company, patients may forgo approved therapies, and that this could result in more severe illness or death.

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The FDA is warning retailers and food service operators not to offer for sale ungutted, salt-cured alewives (also called gaspereaux fish) from Michel & Charles LeBlanc Fisheries Ltd., CAP-PELÈ, New Brunswick, Canada, because the fish may contain the Clostridium botulinum (C. botulinum) toxin. C. botulinum toxin can cause botulism, a serious and sometimes life-threatening condition. The toxin cannot be removed by cooking or freezing. The fish were imported into the United States and sent to these Florida distributors: Quirch Foods Inc., Den-Mar Exports LLC , Dolphin Fisheries Inc., Labrador & Son Food Products Inc.

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The FDA announced that it will add a Boxed Warning to the prescription oral sodium phosphate products Visicol and OsmoPrep to warn consumers about the risk of acute phosphate nephropathy (a type of acute kidney injury). The FDA has also directed the manufacturer of these products to develop a risk evaluation and mitigation strategy (REMS), distribute a Medication Guide to alert patients to the risk of acute kidney injury associated with the use of these products, and to conduct a post-marketing clinical trial to further assess the risk of acute kidney injury with the use of these products.

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The FDA announced that Wilderness Family Naturals LLC of Silver Bay, Minn., and its owners have signed a consent decree that prohibits them from manufacturing and distributing any products with unapproved claims that the products cure, treat, mitigate or prevent diseases. Wilderness Family has a history of promoting its products for the treatment of diseases, and recently referred customers to seemingly independent Web sites that were actually controlled by Wilderness Family. The Web sites claimed benefits for its products against diseases such as cancer, diabetes, heart disease, hyperthyroidism, chronic fatigue syndrome, HIV and AIDS, and arthritis.

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The FDA announced that there is no food or feed safety concern from an incident in which a small portion of an unauthorized genetically engineered (GE) cotton variety was harvested along with commercially available GE cotton. According to Monsanto, an estimated 60 tons of cottonseed was harvested, of which less than 0.5 percent was from the unauthorized GE cotton variety. Government policies for handling low-level presence (LLP) of unauthorized materials are applicable to incidents in which unauthorized materials become inadvertently mixed with commercial grain or seed. FDA, EPA and USDA are working together to investigate the matter.

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The FDA announced the participants in Phase II of its pilot program for voluntary third-party certification programs for imported aquacultured shrimp. The pilot will allow the FDA to identify and address technical and operational issues in assessing certification programs and processing certifications. The pilot program responds to a recommendation in the President¿s Action Plan for Import Safety, issued in November 2007, which called for the development of voluntary third-party certification programs for foreign producers who export to the United States.

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