Food and Drug Administration
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Service Smoked Fish Corp. Recalls Smoked Nova Salmon Because of Possible Health Risk
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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. (Source: Food a...
Source: Food and Drug Administration - November 20, 2009 Category: Food Science Source Type: organizations
Fresh & Easy Neighborhood Market Issues Allergy Alert on Undeclared Pecans in Mislabeled Fresh & Easy Pumpkin Cheesecake Pies
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– 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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 20, 2009 Category: Food Science Source Type: organizations
P&G Voluntarily Recalls Specific Lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 19, 2009 Category: Food Science Source Type: organizations
FDA Takes Action Against Maryland Veal Calf Dealer
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 19, 2009 Category: American Health Source Type: organizations
Nassau Candy Issues Nationwide Allergy Alert Because Of Possible Undeclared Allergens on their Tasty Dish Snack Tubs of Chocolate Almonds, Chocolate Raisins and Sour Neon Worms
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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... (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 19, 2009 Category: Food Science Source Type: organizations
FDA Issues 22 Warning Letters to Web site Operators
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 19, 2009 Category: American Health Source Type: organizations
FDA Takes Action Against Dairy Farm and Owner
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 18, 2009 Category: American Health Source Type: organizations
FDA Announces New Warning on Plavix: Avoid Use with Prilosec/Prilosec OTC
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 18, 2009 Category: American Health Source Type: organizations
SNACKS ON RACKS, INC. Issues Nationwide Allergy Alert because of Undeclared Allergens in Their Gourmet Snacks Pack Product Line
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 18, 2009 Category: Food Science Source Type: organizations
RockHard Laboratories Issues a Voluntary Nationwide Recall of Specific Lots of RockHard Weekend marketed as Dietary Supplement
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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 t...
Source: Food and Drug Administration - November 17, 2009 Category: Food Science Source Type: organizations
FDA Approves New Drug Treatment for Long-Term Pain Relief after Shingles Attacks
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 17, 2009 Category: American Health Source Type: organizations
Cardiovascular Systems Initiates Voluntary Recall of ViperSheathTM Sheath Introducer
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– 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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 17, 2009 Category: Food Science Source Type: organizations
FDA and Everyday Health Collaborate to Expand Reach of Consumer Health Information
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 17, 2009 Category: American Health Source Type: organizations
FDA Approves Additional Vaccine for 2009 H1N1 Influenza Virus
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 16, 2009 Category: American Health Source Type: organizations
Cardiac Science Notifies AED Customers of Nationwide Voluntary Medical Device Correction
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 14, 2009 Category: Food Science Source Type: organizations
New Report Recommends Enhanced Food Tracing Guidelines
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 13, 2009 Category: American Health Source Type: organizations
FDA Approves Lysteda to Treat Heavy Menstrual Bleeding
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 13, 2009 Category: American Health Source Type: organizations
IDS Sports Conducts a Voluntary Nationwide Recall of Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR
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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.” (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 13, 2009 Category: Food Science Source Type: organizations
Conagra Foods Issues Nationwide Allergy Alert on a Limited Number of 15 oz. Tubs of Blue Bonnet Light Spread
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 13, 2009 Category: Food Science Source Type: organizations
FDA Statement on Vibrio Vulnificus in Raw Oysters
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 13, 2009 Category: American Health Source Type: organizations
FDA Clears First Rapid Test for Bacterial Contamination in Pooled Platelets
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 13, 2009 Category: American Health Source Type: organizations
GMP Herbal Products, Inc. Issues a Voluntary Nationwide Recall of a Weight Loss Supplement Found to Contain Undeclared Drug Ingredients
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 13, 2009 Category: Food Science Source Type: organizations
FDA To Look Into Safety of Caffeinated Alcoholic Beverages
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 13, 2009 Category: American Health Source Type: organizations
FDA Takes Action against Seafood Processing Company, Executives
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 13, 2009 Category: American Health Source Type: organizations
U.S. Attorney News Release: Operators of Burien Salon Plead Guilty in Case Involving Bribe and Illegal Import of Cosmetic Equipment
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 13, 2009 Category: American Health Source Type: organizations
FDA Expands Use of CSL Limited’s Seasonal and H1N1 Vaccines to Infants and Children
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 12, 2009 Category: American Health Source Type: organizations
FDA Expands Approved Use of H1N1 Vaccines to Include Infants and Children
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 12, 2009 Category: American Health Source Type: organizations
U.S. Attorney News Release: Computer Salesman Pleads Guilty to Misbranding a Drug and Copyright Infringement
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 12, 2009 Category: American Health Source Type: organizations
U.S. Attorney News Release: Health Care Professional Sentenced To Prison For Product Tampering
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Demerol Diverted at Bellevue Surgery Clinic
DREA LYNNE GIBSON, 43, of Fall City, Washington, was sentenced today in U.S. District Court in Seattle to a year and a day in prison and three years of supervised release for product tampering in violation of federal law. GIBSON pleaded guilty in May 2009, admitting that she tampered with doses of Demerol, a narcotic pain medication, at the surgical center where she worked. At sentencing U.S. District Judge Ricardo Martinez said, “This is an extremely serious offense. Using Demerol for herself is one thing, stealing it is another. But replacing it with something else takes it ...
Source: Food and Drug Administration - November 11, 2009 Category: American Health Source Type: organizations
FDA Commissioner Addresses Nation’s Healthcare Professionals on H1N1 Vaccine
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 10, 2009 Category: American Health Source Type: organizations
FDA Approves Drug Treatment for Rare Cancer
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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). (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 9, 2009 Category: American Health Source Type: organizations
FDA Issues 2009 FDA Food Code
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Updated code is a model for state, city, county, tribal, territorial agencies and industry.
The Food and Drug Administration today announced the publication of the new FDA Food Code, a model code and reference document that provides a scientifically sound technical and legal basis for regulating the retail and food service segment of the food industry. The 2009 FDA Food Code is a key component of the President’s overall public-health-focused food safety framework for maintaining a safe food supply. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 9, 2009 Category: American Health Source Type: organizations
Hospira Issues Nationwide Voluntary Recall of Certain Lots of Liposyn™ and Propofol Products That May Contain Particulate Matter
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 9, 2009 Category: Food Science Source Type: organizations
Jelly Belly Issues Allergy Alert on Undeclared Peanuts in 7.5oz cylinder-style packages of 49 Flavors Jelly Belly jelly beans
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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... (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 6, 2009 Category: Food Science Source Type: organizations
FDA Warns Companies against Marketing Illegal Flavored Cigarettes
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The U.S. Food and Drug Administration is enforcing the flavored cigarette ban provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) by issuing several warning letters to companies continuing to sell illegal flavored cigarettes to consumers in the United States through their Web sites. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 6, 2009 Category: American Health Source Type: organizations
FDA Health Alert for Certain Pet Treats Made by Pet Carousel
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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. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 6, 2009 Category: American Health Source Type: organizations
FDA and FSIS Collaborate To Improve Tracing of Unsafe Food Products
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A joint public meeting focused on improving the system for tracing of food products and ingredients that are causing illness outbreaks or presenting other risks to the health of consumers was announced today by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA). (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 5, 2009 Category: American Health Source Type: organizations
PetSmart Voluntarily Recalls Dentley’s Beef Hooves
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PetSmart (NASDAQ: PETM) is voluntarily recalling two Dentley’s Beef Hoof products for potential salmonella contamination. The products were manufactured by Pet Carousel, Inc. in Sanger, Calif. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 5, 2009 Category: Food Science Source Type: organizations
FDA Warns Consumers on Sexual Enhancement Products
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The U.S. Food and Drug Administration is warning consumers that Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 5, 2009 Category: American Health Source Type: organizations
FDA Unveils Safe Use Initiative that Targets Preventable Harm from Medication Use
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The U.S. Food and Drug Administration today announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 4, 2009 Category: American Health Source Type: organizations
Centurion Medical Products - Premie Pack and Meconium Pack - Recall
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Kits recalled because the pediatric tracheal tubes were manufactured with an internal diameter smaller than indicated on the label. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 4, 2009 Category: Food Science Source Type: organizations
Charleston Cookie Company Issues Allergy Alert on Undeclared Butter in Almond Cookies Produced for Dean & Deluca
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Charleston Cookie Company of Charleston, SC is recalling packages of Almond Cookies which were sold as a component of the Dean and Deluca "Americana" cookie tin because the cookies contain undeclared butter (milk). (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 4, 2009 Category: Food Science Source Type: organizations
U.S. Attorney News Release: Doctor Sentenced for Writing Prescriptions Over the Internet for People Whom He Had Never Met or Examined
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A Virginia doctor was sentenced in federal court on charges that he wrote prescriptions over the Internet for people whom he had never met or examined, as well as tax evasion. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 4, 2009 Category: American Health Source Type: organizations
American Regent Expands Voluntary Recall to Include All Lots of Ketorolac Tromethamine Injection, USP 15 mg/mL; 1mL Single Dose Vials
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American Regent conducts nationwide voluntary recall of ALL lots of its Ketorolac Tromethamine Injection, USP 15 mg/mL:
NDC# 0517-0601-25 15 mg/mL 1mL Single Dose Vial
PLEASE NOTE: This recall is in addition to the voluntary recall initiated on October 16, 2009 when American Regent voluntarily recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 4, 2009 Category: Food Science Source Type: organizations
Pelican Bay Ltd. Issues Nationwide Allergy Alert on Undeclared Tree Nuts in Caramel Chocolate Truffle Hot Chocolate Mix
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Pelican Bay Ltd. of Dunedin, Florida is recalling all their Caramel Chocolate Truffle Hot Chocolate Mix because it may contain undeclared tree nuts. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 3, 2009 Category: Food Science Source Type: organizations
BODYBUILDING.COM Is Conducting a Voluntary Nationwide and International Recall of 65 Dietary Supplements That May Contain Steroids
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As part of its ongoing
cooperation with the Food and Drug Administration (“FDA”), Bodybuilding.com, LLC (the
“Company”) announced today that it is conducting a voluntary nationwide and international
recall of all lots and expiration dates of 65 dietary supplement products (the “Recalled Products”)
described on the attached list, that were sold through the Company’s website,
www.bodybuilding.com. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 3, 2009 Category: Food Science Source Type: organizations
FDA, JIFSAN Travel to Bangladesh to Teach Seafood Safety
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The U.S. Food and Drug Administration and the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) have sent a team of seafood specialists to Bangladesh this week to help train local officials on aquaculture safety and quality control techniques. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 2, 2009 Category: American Health Source Type: organizations
FDA Consumer Health Information Updates
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The U.S. Food and Drug Administration (FDA) today released a listing of eight recent consumer health information updates concerning the safety of FDA-regulated products. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 2, 2009 Category: American Health Source Type: organizations
FDA Publishes Guidance on Diagnostic Tests for 2009 H1N1 Influenza Virus
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The U.S. Food and Drug Administration today published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic, manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA). If granted, the EUA will allow the test to be used during the national public health emergency declared by Department of Health and Human Services Secretary Kathleen Sibelius in April. This guidance document outlines what information the FDA recommends that m...
Source: Food and Drug Administration - November 2, 2009 Category: American Health Source Type: organizations
FDA Transparency Task Force to Hold 2nd Public Meeting on Ensuring That Agency Information is Useful, Understandable, Accessible
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The U.S. Food and Drug Administration will seek comments on three specific issues related to transparency at the agency during a daylong public meeting on Tuesday, Nov. 3, 2009. (Source: Food and Drug Administration)
Source: Food and Drug Administration - November 2, 2009 Category: American Health Source Type: organizations
