November 22, 2008FDA Acts to Avoid Shortage and Strengthen the Safety of Sucraid FDA Acts to Avoid Shortage and Strengthen the Safety of Sucraid
The U.S. Food and Drug Administration today issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution. Bottled Water Everywhere: Keeping it Safe Americans drink billions of gallons of bottled water each year. Find out about FDA's role in ensuring that bottled water products are safe. FDA Warns Public of Extortion Scam by FDA Impersonators The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. Outsmarting Poison Ivy and Other Poisonous Plants Poison ivy and other poisonous plants are a hazard all year round. Here are tips for preventing and treating the itchy rash and blisters. Drug Shortages: Resolved Drug Shortages; Vinblastine Sulfate Injection See Related information section FDA delays decision on Genzyme drug - Boston Globe FDA delays decision on Genzyme drug - Boston Globe
Genzyme Corp ., a Cambridge drug maker, said the US Food and Drug Administration has extended its deadline for reviewing Genzyme's application to market a new version of Myozyme, a drug for Pompe disease, manufactured at the company's Boston plant by Source: www.boston.com Now see this: Ohio boy gets prosthetic iris - Newark Advocate CINCINNATI (AP) — An Ohio boy born without irises is starting to see colors more clearly after receiving a prosthetic iris. Surgeons from the Cincinnati Eye Institute implanted the custom-made device Thursday into the right eye of 7-year-old Source: www.newarkadvocate.com US Food and Drug Administration to open China offices in effort to - Duluth News Tribune The U.S. Food and Drug Administration will open three offices in China this week in an unprecedented effort to improve the safety of exports headed to America amid recurring product safety scares. The new FDA offices, which are the first outside of Source: www.duluthnewstribune.com New mad cow rule poses dangers of its own - Dubuque Telegraph Herald LITITZ, Pa. (AP) -- A federal regulation aimed at preventing mad cow disease from getting into the food supply could create health risks of its own: many thousands of cattle carcasses rotting on farms, spreading germs, attracting vermin and polluting Source: www.thonline.com Wolters Kluwer Health Expands Tall Man Drug Name Lettering in Medi - Businesswire.com INDIANAPOLIS--( BUSINESS WIRE )--Wolters Kluwer Health, a leading global provider of information for healthcare professionals and students, announced today that its Medi-Span product line will significantly increase the number of “ Tall Man Source: www.businesswire.com Parents seek solution for coughs and colds - Times Daily Parents seek solution for coughs and colds - Times Daily
For years, if a child had a cough or cold, parents could find a wide selection of over-the-counter medications. Coughs and colds An estimated 10 percent of American kids take one or more cough and cold medications during a given week. A FDA review Source: www.timesdaily.com FDA Approves New Drug for Severe Epilepsy - BusinessWeek FRIDAY, Nov. 21 (HealthDay News) -- A new drug called Banzel (rufinamide) has been approved as a supplementary treatment for a severe form of epilepsy called Lennox-Gastaut syndrome, the U.S. Food and Drug Administration announced Friday. The Source: www.businessweek.com UPDATE: Annan, Carter Denied Visas, Cancel Zimbabwe Trip - Beurs.nl JOHANNESBURG (AFP)--Former U.N. Secretary General Kofi Annan and former U.S. President Jimmy Carter said Saturday they had been forced to cancel a trip to Zimbabwe because they hadn't been given their visas. 'We had to cancel our visit because the Source: www.beurs.nl Allergens hide out in kids' food - Akron Beacon Journal CHICAGO: American children with food allergies are suffering life-threatening — and completely avoidable — reactions because manufacturers mislabel their products and regulators fail to police store shelves, a Chicago Tribune investigation has Source: www.ohio.com FDA's plan to keep mad-cow disease out of food supply presents own - Arizona Daily Star LITITZ, Pa. — A federal regulation aimed at preventing mad-cow disease from getting into the food supply could create health risks of its own: many thousands of cattle carcasses rotting on farms, spreading germs, attracting vermin and polluting the Source: www.azstarnet.com November 21, 2008Recalls and Safety Alerts: Increased Risk of Death in Elderly Patients Taking Conventional Antipsychotics for Dementia Recalls and Safety Alerts: Increased Risk of Death in Elderly Patients Taking Conventional Antipsychotics for Dementia
FDA is requiring that "conventional" antipsychotic drugs carry a boxed warning stating that these drugs increase the risk of death when they are used to treat dementia-related psychosis in elderly patients. This category includes such drugs as Haldo... Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Related information section for posted letter Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial) See Web site for additional information Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10% See information in Related Information section. FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Related information section for updated Letter from Mallinckrodt Drug Shortages: Resolved Drug Shortages; Fentanyl transdermal patch See Related information section Drug Shortages: Resolved Drug Shortages; Vinblastine Sulfate Injection See Related information section The Comeback of the Century? - Motley Fool The Comeback of the Century? - Motley Fool
AstraZeneca 's (NYSE: AZN ) Iressa had such potential . The lung cancer therapy was given an accelerated approval by the Food and Drug Administration in 2003 based on initial trial results. But the follow-up trial 18 months later showed that patients Source: www.fool.com Senator Urges FDA To Investigate Lead, Dental Work - WBNS 10TV Columbus COLUMBUS, Ohio — Senator Sherrod Brown on Friday called on the Food and Drug Administration to further explore the presence of lead in dental work. In a letter, Brown urged the FDA to explore its standards for domestic and foreign dental work, and Source: www.10tv.com More money and strong leader wanted at FDA - Reuters NEW YORK (Reuters) - Drug makers are calling for steady leadership, political independence and a boost in funding to improve the climate at the U.S. Food and Drug Administration under President-elect Barack Obama. The FDA has suffered with high Source: www.reuters.com Ligand and Glaxo Like the FDA's Answer - Motley Fool Christmas came really early for GlaxoSmithKline (NYSE: GSK ) and Ligand Pharmaceuticals (Nasdaq: LGND ) , and the drugmakers got exactly what they wanted: favorable news from the jolly old elves at the Food and Drug Administration. After months of Source: www.fool.com FDA Accepts Filing and Grants Priority Review for DX-88 for Hereditary - Phramalive.com CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov 21, 2008 - Dyax Corp. (NASDAQ: DYAX) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's Biologics License Application (BLA) for DX-88 (ecallantide) for the Source: www.pharmalive.com FDA approves GSK's Promacta (Eltrombopag) - News-Medical.Net GlaxoSmithKline has announced that the United States Food and Drug Administration (FDA) granted accelerated approval for PROMACTA (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic Source: www.news-medical.net The Globavore's Dilemma Your questions about food contamination, with - Slate A baby drinks formula The Food and Drug Administration opened a new branch in Beijing on Wednesday in response to a spate of recent high-profile contamination scares. Meanwhile, the embarrassed Chinese government has promised to tighten inspection Source: www.slate.com Popular plastic surgery option can lead to blotches, bumps and scars - Minneapolis Star Tribune WASHINGTON - Hundreds of thousands of baby boomer women who think they've found an antidote to aging in cosmetic facial fillers must be better informed of possible risks, government health advisers said Tuesday. A panel of independent advisers urged Source: www.startribune.com The Globavore's Dilemma Your questions about food contamination, with - Slate The Globavore's Dilemma Your questions about food contamination, with - Slate
A baby drinks formula The Food and Drug Administration opened a new branch in Beijing on Wednesday in response to a spate of recent high-profile contamination scares. Meanwhile, the embarrassed Chinese government has promised to tighten inspection Source: www.slate.com Johnson & Johnson gets FDA approval for pain drug - CNN Money NEW YORK (Associated Press) - Diversified health care company Johnson & Johnson said Friday the Food and Drug Administration approved its pain drug Tapentadol. The drug is only approved for adults. The Drug Enforcement Agency will now review the Source: money.cnn.com Jazz Pharmaceuticals, partner report positive fibromyalgia drug tests - San Jose Business Journal Jazz Pharmaceuticals Inc. and partner biopharmaceutical company UCB S.A. Belgium on Friday reported positive results from the first of two Phase III clinical trials for treating fibromyalgia. Palo Alto-based Jazz (NASDAQ:JAZZ) and UCB already engaged Source: sanjose.bizjournals.com More money and strong leader wanted at FDA - Reuters NEW YORK (Reuters) - Drug makers are calling for steady leadership, political independence and a boost in funding to improve the climate at the U.S. Food and Drug Administration under President-elect Barack Obama. The FDA has suffered with high Source: www.reuters.com New mad-cow rule poses health dangers of its own - Evening Sun LITITZ, Pa.—A federal regulation aimed at preventing mad cow disease from getting into the food supply could create health risks of its own—thousands of cattle carcasses rotting on farms. At issue is a Food and Drug Administration rule that will Source: www.eveningsun.com Ligand and Glaxo Like the FDA's Answer - Motley Fool Christmas came really early for GlaxoSmithKline (NYSE: GSK ) and Ligand Pharmaceuticals (Nasdaq: LGND ) , and the drugmakers got exactly what they wanted: favorable news from the jolly old elves at the Food and Drug Administration. After months of Source: www.fool.com FDA Approves Epilepsy Drug - Post Chronicle The U.S. Food and Drug Administration has approved a new drug, rufinamide -- marketed as Banzel -- to treat severe epilepsy. The drug is to be used as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome. "This approval offers Source: www.postchronicle.com US drug panel splits on pair of antibiotics - International Herald Tribune COLLEGE PARK, Maryland : Federal health advisers on Wednesday backed the benefits of an experimental antibiotic but rebuffed another, citing questions that it would be able to fight dangerous staph infections that are becoming increasingly common. A Source: www.iht.com FDA approves GSK's Promacta (Eltrombopag) - News-Medical.Net GlaxoSmithKline has announced that the United States Food and Drug Administration (FDA) granted accelerated approval for PROMACTA (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic Source: www.news-medical.net Nestle Withdraws Nestle Farinha Lactea Cereal in the United States (November 3) Nestle Withdraws Nestle Farinha Lactea Cereal in the United States (November 3)
Nestle is withdrawing Nestle Farinha Lactea cereal in the United States. Nestle is taking this action as we have learned that the product may contain residual traces of a pesticide not currently approved for use on wheat in the U.S. While the pesticide is approved for use in Brazil and the noted levels are well below Brazilian standards, it is not used on wheat products in the United States and therefore there is no set standard for its presence in cereal. The pesticide is permitted in the United States on grain crops other than wheat. CSI USA, Inc. Issues Voluntary National Recall of Topical Acne Cream (November 13) CSI, USA, Inc. issued a voluntary nationwide consumer product recall of all lots of 1 ounce (28 g) tubes of 10 Percent Benzoyl Peroxide Acne Cream with the following names: "DG Maximum Strength Acne Medicated Gel" (sold at Dollar General); "Kroger Acne Gel 10 Percent Benzoyl Peroxide Acne Medication" (sold at Kroger); and "Equate: Medicated Acne Gel" (sold at Wal-Mart). Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY Gourmet Sold at Wal-Mart locations in Fifteen States due to Potential Salmonella Contamination Mars Petcare US today announced a voluntary recall of a limited number of bags of SPECIAL KITTY Gourmet Blend dry cat food sold at Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia. The pet food is being voluntarily recalled following a positive test result indicating a potential contamination with Salmonella. Recalls and Safety Alerts: Serious Fungal Infections with Humira, Cimzia, Enbrel and Remicade The manufacturers of Humira (adalimumab), Cimzia (certolizumab pegol), Enbrel (etanercept), and Remicade (infliximab) must strengthen warnings about the risk of developing opportunistic fungal infections from these drugs. These infections have been ... Roche's RoActemra Receives Backing From EU Drug Regulator - CNN Money Roche's RoActemra Receives Backing From EU Drug Regulator - CNN Money
ZURICH -(Dow Jones)- Swiss drugmaker Roche Holding AG (RHHBY) said Friday it received the backing of medical advisors to the European Union Commission for RoActemra, a new drug for the treatment of rheumatoid arthritis. Roche, based in Basel , said Source: money.cnn.com Amgen gets positive EU nod for blood-clot drug - CNN Money NEW YORK (Associated Press) - Shares of Amgen Inc. rose Friday after the company said a European advisory committee is in favor of approving the biotechnology company's drug Nplate, which treats a rare blood-clotting disorder. The stock rose $1.27 Source: money.cnn.com Drug Resistance Differences Among HIV Types and Subtypes: A Growing - Medscape News The material presented here does not necessarily reflect the views of Medscape or companies that support educational programming on www.medscape.com. These materials may discuss therapeutic products that have not been approved by the US Food and Drug Source: www.medscape.com The Globavore's Dilemma Your questions about food contamination, with - Slate The Food and Drug Administration opened a new branch in Beijing on Wednesday in response to a spate of recent high-profile contamination scares. Meanwhile, the embarrassed Chinese government has promised to tighten inspection standards in the wake of Source: www.slate.com Top U.S. Health Official: American Importers Have Duties on Product - Wall Street Journal U.S. Secretary of Health and Human Services Michael O. Leavitt – speaking in Shanghai at the tail end of a visit to China this week to open outposts of the U.S. Food and Drug Administration –- said American importers of Chinese goods also have an Source: blogs.wsj.com FDA Approves New Option to Treat Major Depression - Psychiatric News The clearance of the transcranial magnetic stimulation device gives psychiatrists a new weapon to treat depression. The Food and Drug Administration (FDA) has cleared the first transcranial magnetic stimulation (TMS) device for treatment of Source: pn.psychiatryonline.org Children at risk in food roulette - Chicago Tribune American children with food allergies are suffering life-threatening--and completely avoidable--reactions because manufacturers mislabel their products and regulators fail to police store shelves, a Tribune investigation has found. In effect Source: www.chicagotribune.com E-cigarette gets the FDA's attention - KVUE It looks like, puffs like, but isn't a cigarette. There's no tar or tobacco in the electronic device called Smoking Everywhere, but because there is real nicotine, the Food and Drug Administration is investigating whether e-cigarettes should be Source: www.kvue.com Targanta shares dive 82% after drug is rejected - Boston Globe Targanta shares dive 82% after drug is rejected - Boston Globe
Shares of Targanta Therapeutics Corp. plummeted 82 percent yesterday, a day after the Cambridge biotechnology company failed to convince a federal advisory panel that its key product, an experimental antibiotic, should be approved. The Food and Drug Source: www.boston.com Glemnark recieves USFDA approval for Ranitidine tablets - Reuters India MUMBAI, Nov 21 (Reuters) - Glenmark Pharmaceuticals Ltd (GLEN.BO: Quote , Profile , Research ) received approval from the United States Food and Drug Administration for distribution and marketing of Ranitidine tablets in the U.S. market, it said in a Source: in.reuters.com FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer
The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity. FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. Using Over-the-Counter Cough and Cold Products in Children FDA supports the voluntary actions of drug manufacturers to better inform consumers about the safe and effective use of over-the-counter cough and cold medicines in children. Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24) Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. Nonna's Real Italiana Cuccine Issues an Allergy Alert on Undeclared Milk, Soy, and Wheat in Stuffed Artichokes (October 22) This product is distributed through retailers in the Greater New Orleans area including the Northshore from October 8, 2008 to October 17, 2008. The product is individually wrapped in clear plastic wrap bearing the label: "STUFFED ARTICHOKE, Net Wt. 15 oz., NONNA'S REAL ITALIANA CUCCINE". Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. Amy's Kitchen Inc. Issues Allergy Alert and Voluntary National Recall due to Possible Undeclared Milk in Tofu Scramble in a Pocket Sandwich; Lot Code H148 (November 7) The products could cause an allergic reaction if consumed by any individuals allergic to milk. People who have an allergy or severe sensitivity to dairy products run the risk of serious or life-threatening allergic reaction if they consume the product. Consumers without milk allergies can safely consume the product. November 20, 2008Recalls and Safety Alerts: Serious Fungal Infections with Humira, Cimzia, Enbrel and Remicade Recalls and Safety Alerts: Serious Fungal Infections with Humira, Cimzia, Enbrel and Remicade
The manufacturers of Humira (adalimumab), Cimzia (certolizumab pegol), Enbrel (etanercept), and Remicade (infliximab) must strengthen warnings about the risk of developing opportunistic fungal infections from these drugs. These infections have been ... Propafenone HCl Tablets (150 mg, 225 mg, 300 mg), Isosorbide Mononitrate Extended Release Tablets (30 mg and 60 mg), Morphine Sulfate Extended Release Tablets (15 mg), Morphine Sulfate Immediate Release Tablets (15 mg and 30 mg), Dextroamphetamine Sulfate Tablets (10 mg) Propafenone HCl Tablets (150 mg, 225 mg, 300 mg), Isosorbide Mononitrate Extended Release Tablets (30 mg and 60 mg), Morphine Sulfate Extended Release Tablets (15 mg), Morphine Sulfate Immediate Release Tablets (15 mg and 30 mg), Dextroamphetamine Sulfate Tablets (10 mg)
Generic products recalled because of the potential for oversized tablets that could cause serious or life-threatening consequences. Outsmarting Poison Ivy and Other Poisonous Plants Poison ivy and other poisonous plants are a hazard all year round. Here are tips for preventing and treating the itchy rash and blisters. Benzoyl Peroxide Acne Cream 10% marked as: DG Maximum Strength Acne Medicated Gel; Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication; Equate: Medicated Acne Gel Voluntary recall due to samples of the products containing Burkholderia Cepacia bacteria. Update on Early Communication: Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D); Etidronate (Didronel); Ibandronate (Boniva); Pamidronate (Aredia); Risedronate (Actonel, Actonel W/Calcium); Tiludronate (Skelid); Zoledronic acid (Reclast, Zometa) Early Communication about the FDA's review of safety data showed no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation Use Caution With Ayurvedic Products The presence of heavy metals in some Ayurvedic products makes them potentially harmful. In-Body Pediatric Devices Pose Unique Challenges Implantable pediatric medical devices are exciting examples of cutting-edge medical technology. But they require special considerations on the part of parents, health professionals, and scientists who design devices. Thoratec HeartMate II Left Ventricular Assist System Device correction because the wear and fatigue of the percutaneous lead connecting the blood pump with the system controller may cause serious injury or death. Recalls and Safety Alerts: Serious Hypersensitivity Reactions with Abacavir (Ziagen) FDA is alerting healthcare professionals that certain patients are more likely to experience serious and potentially fatal hypersensitivity reactions when treated with the antiretroviral drug abacavir. Abacavir is sold under the trade name Ziagen an... FDA Requires Stronger Fungal Infection Warning for TNF Blockers FDA has told the makers of drugs known as "tumor necrosis factor alpha blockers" (TNF-alpha blockers) to strengthen existing labeling. Recalls and Safety Alerts: Updated Warning on Byetta In October 2007, FDA warned healthcare professionals about reports of acute pancreatitis in patients taking the antidiabetic drug Byetta (exenatide). Since then, FDA has received reports of six cases of hemorrhagic or necrotizing pancreatitis in pat... FDA approves generic version of Astra asthma drug - Seattle Times FDA approves generic version of Astra asthma drug - Seattle Times
Pharmaceutical company AstraZeneca PLC said Wednesday that its rival Teva Pharmaceutical Industries Ltd. has been granted approval by the U.S. Federal Drug Administration for a generic version of its child asthma medication Pulmicort Respules Source: seattletimes.nwsource.com Bottled Water Everywhere: Keeping it Safe Bottled Water Everywhere: Keeping it Safe
Americans drink billions of gallons of bottled water each year. Find out about FDA's role in ensuring that bottled water products are safe. FDA Warns Bayer About Two Unapproved Aspirin Products FDA has sent warning letters to Bayer HealthCare regarding two over-the-counter products that combine aspirin with a dietary supplement into a single pill. Thoratec HeartMate II Left Ventricular Assist System Device correction because the wear and fatigue of the percutaneous lead connecting the blood pump with the system controller may cause serious injury or death. Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator Class I recall because of unsupported claims. Preventing Medical Errors: Tragic Events with Concentrated Opiate Oral Solutions An alert from the Institute for Safe Medication Practices warns about potentially fatal errors that can occur with concentrated oral opiate solutions. ISMP cites a recent case involving an 18 year old who was prescribed oxycodone oral solution to ... Is It Really FDA Approved? Some marketers say their products are "FDA approved", but how can you know for sure? Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. Update on Early Communication: Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D); Etidronate (Didronel); Ibandronate (Boniva); Pamidronate (Aredia); Risedronate (Actonel, Actonel W/Calcium); Tiludronate (Skelid); Zoledronic acid (Reclast, Zometa) Early Communication about the FDA's review of safety data showed no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation November 19, 2008Drug Shortages: Resolved Drug Shortages; Argatroban InjectionGood luck to FDA Friday - Greenville Advocate Good luck to FDA Friday - Greenville Advocate
To many of the football players at Fort Dale Academy, this may feel like the longest week of their lives. The ballgame in Troy Friday represents the culmination of a year of hard work and preparation. A state championship is the ultimate goal at the Source: www.greenvilleadvocate.com HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief
Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections. FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity. Harry and David Issues Nationwide Allergy Alert on Undeclared Pecans in Harry and David Moose Munch Confection, Milk Chocolate Gingerbread (October 22) Harry and David, of Medford, Oregon, is voluntarily recalling approximately 400 1 lb. 4 oz. boxes labeled Harry and David Moose Munch Confection, Milk Chocolate Gingerbread because the package may contain a different Moose Munch product which contains pecans not declared on the ingredient statement. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume this product. Recalls and Safety Alerts: Serious Injection Site Reactions with Vivitrol FDA is alerting healthcare professionals about the risk of serious reactions at the injection site among patients treated with Vivitrol (naltrexone). Vivitrol is administered intramuscularly to treat alcohol dependence. FDA has received nearly ... Everlasting Distributors Inc. Issues a Nationwide Recall of Fresh and Crispy Jacobina Biscuits Because of Possible Health Risks (October 29) Everlasting Distributors Inc., Bayonne NJ is initiating a nationwide recall of all their 3.88oz (110gm) packages of Fresh and Crispy Jacobina Biscuits because it may be contaminated with Melamine. FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. Nestle Withdraws Nestle Farinha Lactea Cereal in the United States (November 3) Nestle is withdrawing Nestle Farinha Lactea cereal in the United States. Nestle is taking this action as we have learned that the product may contain residual traces of a pesticide not currently approved for use on wheat in the U.S. While the pesticide is approved for use in Brazil and the noted levels are well below Brazilian standards, it is not used on wheat products in the United States and therefore there is no set standard for its presence in cereal. The pesticide is permitted in the United States on grain crops other than wheat. Recalls and Safety Alerts: Importance of Influenza Vaccination for Health Care Personnel As the flu season approaches, FDA is urging healthcare facilities to ensure that influenza vaccination programs are available for their personnel. Vaccinating healthcare workers will decrease the likelihood that they will contract influenza, and als... November 18, 2008US says will work with China on product safety - Jakarta Post US says will work with China on product safety - Jakarta Post
US says will work with China on product safety The Associated Press , Beijing | Wed, 11/19/2008 8:39 AM | World The United States prepared to open its first Food and Drug Administration offices outside the country Wednesday as it works Source: www.thejakartapost.com Facial fillers should have better labeling on risks, FDA panel says - Los Angeles Times Reporting from Washington -- Cosmetic surgery patients who think facial fillers are a magical antidote to aging should be better informed of possible risks, government health advisors said Tuesday. A panel of independent advisors urged the Food and Source: www.latimes.com Drugs' Heart Risk Is FDA's Biggest Worry: Official - Post Chronicle The rise of serious heart risks in drugs that treat chronic conditions has become one of the U.S. Food and Drug Administration's top worries and is changing how the agency weighs new medicines, a top FDA official said on Tuesday. The agency is Source: www.postchronicle.com FDA Extends METOZOLVâ„¢ ODT Review Date - PR Inside www.salix.com - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the U.S. Food and Drug Administration (FDA) has informed Wilmington Pharmaceuticals that the Prescription Drug User Fee Act action date for the New Drug Application (NDA Source: www.pr-inside.com Aurobindo Pharma gets first US nod for alfuzosin HCL - Reuters India MUMBAI, Nov 19 (Reuters) - The U.S. Food and Drug Administration has tentatively approved Aurobindo Pharma Ltd's (ARBN.BO: Quote , Profile , Research ) alfuzosin hydrochloride extended release tablets, the regulator's website showed. The drug is used Source: in.reuters.com US says will work with China on product safety - Jakarta Post The United States prepared to open its first Food and Drug Administration offices outside the country Wednesday as it works with China to strengthen measures to ensure products imported into the U.S. are safe. Worries about the quality of Chinese Source: www.thejakartapost.com Use of antipsychotics in children is criticized - International Herald Tribune WASHINGTON : Powerful antipsychotic medicines are being used far too cavalierly in children, and federal drug regulators must do more to warn doctors of their substantial risks, a panel of federal drug experts said Tuesday. More than 389,000 children Source: www.iht.com U.S. opening food inspection office in Beijing - International Herald Tribune HONG KONG : After 18 months of food and safety scandals involving Chinese-made toys, toothpaste, cough syrup, pet food, drugs and milk, the United States on Wednesday was to open a Beijing office of the Food and Drug Administration. The office is the Source: www.iht.com US to open Food and Drug Administration office in China to help - MSN UK News The U.S. is preparing to open its first Food and Drug Administration office in China to strengthen measures to ensure products imported into the U.S. are safe. U.S. Health and Human Services Secretary Mike Leavitt says a new strategy is needed Source: news.uk.msn.com US says will work with China on product safety - International Herald Tribune US says will work with China on product safety - International Herald Tribune
BEIJING : The United States prepared to open its first Food and Drug Administration offices outside the country Wednesday as it works with China to strengthen measures to ensure products imported into the U.S. are safe. Worries about the quality of Source: www.iht.com Genzyme treatment gets FDA fast track - Boston Business Journal Genzyme Corp. (Nasdaq: GENZ) announced that an accelerated approval schedule for Myozyme, a treatment for Late Onset Pompe disease, a life-threatening disorder affecting about 2,000 people in the United States. According to a company press release Source: boston.bizjournals.com Shares of Targanta surge on positive FDA review - Forbes The Cambridge, Mass.-based company asked the Food and Drug Administration to approve oritavancin for use against serious skin infections caused by antibiotic-resistant bacteria. The FDA will ask a panel of outside experts to weigh in on the Source: www.forbes.com Reuters Summit-US FDA working to meet drug deadlines - Guardian Unlimited NEW YORK, Nov 18 (Reuters) - U.S. regulators are aiming to meet more drug approval deadlines after what may have been the worst year for evaluating products on time, a senior Food and Drug Administration official said on Tuesday. The FDA agreed to Source: www.guardian.co.uk FDA Extends METOZOLVâ„¢ ODT Review Date - PR Inside www.salix.com - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the U.S. Food and Drug Administration (FDA) has informed Wilmington Pharmaceuticals that the Prescription Drug User Fee Act action date for the New Drug Application (NDA Source: www.pr-inside.com Use Caution With Ayurvedic Products Use Caution With Ayurvedic Products
The presence of heavy metals in some Ayurvedic products makes them potentially harmful. FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes (November 5) The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. Vaccines Stand Ready for Flu Season FDA has approved six vaccines for the 2008-2009 flu season. The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk (October 20) The Hartz Mountain Corporation, Secaucus, NJ is voluntarily recalling one specific lot of Hartz Chicken-Basted Rawhide Chips due to concerns that one or more bags within the lot are potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall. Harry and David Issues Nationwide Allergy Alert on Undeclared Pecans in Harry and David Moose Munch Confection, Milk Chocolate Gingerbread (October 22) Harry and David, of Medford, Oregon, is voluntarily recalling approximately 400 1 lb. 4 oz. boxes labeled Harry and David Moose Munch Confection, Milk Chocolate Gingerbread because the package may contain a different Moose Munch product which contains pecans not declared on the ingredient statement. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume this product. Antisoma AGM update and Interim Management Statement - MSN MoneyCentral Antisoma AGM update and Interim Management Statement - MSN MoneyCentral
Cancer drug developer Antisoma plc (LSE: ASM; USOTC: ATSMY) holds its AGM today and provides an update on its key pipeline products and other corporate developments. Glyn Edwards, Antisoma's CEO, said: "We are finishing 2008 in a strong position Source: news.moneycentral.msn.com US Food and Drug Administration to open China offices - China Economic Net The US Food and Drug Administration will open three offices in China this week to help check the safety of exports headed to America. The new FDA offices, which are the first outside of the United States, will increase effectiveness in protecting Source: en.ce.cn Mylan Pharmaceuticals (MYL) Receives Tentative FDA Approval for - StreetInsider.com Mylan Pharmaceuticals (MYL) Receives Tentative FDA Approval for Generic Effexor XR Mylan Receives Tentative FDA Approval for the Generic Version of the Antidepressant Effexor XR(R) Morgan Stanley Starts Mylan (MYL) at Overweight Mylan's Dey L.P Source: www.streetinsider.com China urges US to lift food import restrictions - San Francisco Gate The Chinese Foreign Ministry said it regretted the move by the U.S. Food and Drug Administration last Thursday to order dozens of imported foods from China held at the border. Most are ethnic treats, including snacks, drinks and chocolates. The U.S Source: www.sfgate.com China urges US to lift food import restrictions, saying food safety - Daily Press BEIJING (AP) _ China urged Washington on Tuesday to lift new restrictions that U.S. health officials have imposed on imported foods from China, insisting Beijing has taken effective measures to improve food safety standards since it was hit by a Source: www.dailypress.com UPDATE 1-Targanta drug appears similar to rival-US FDA staff - Forbes NEW YORK, Nov 17 (Reuters) - Targanta Therapeutics Corp's clinical trial data show its antibiotic is about as safe and effective as another similar drug already on the U.S. market, Food and Drug Administration staff said on Monday. In general, the Source: www.forbes.com FDA will open product-safety offices in China - The Washington Times The U.S. Food and Drug Administration will open three offices in China this week in an unprecedented effort to improve the safety of exports headed to America amid recurring product-safety scares. The new FDA offices, which are the first outside of Source: www.washingtontimes.com US Food and Drug Administration to open China offices in effort to - Minneapolis Star Tribune BEIJING - The U.S. Food and Drug Administration will open three offices in China this week in an unprecedented effort to improve the safety of exports headed to America amid recurring product safety scares. The new FDA offices, which are the first Source: www.startribune.com Shares of Targanta surge on positive FDA review - Forbes The Cambridge, Mass.-based company asked the Food and Drug Administration to approve oritavancin for use against serious skin infections caused by antibiotic-resistant bacteria. The FDA will ask a panel of outside experts to weigh in on the Source: www.forbes.com Targanta Therapeutics announces posting of briefing documents for - News-Medical.Net Targanta Therapeutics Corporation announced today that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the November 19, 2008 Anti-Infective Drugs Advisory Committee (AIDAC) meeting. AIDAC will review Source: www.news-medical.net Use Caution With Ayurvedic Products Use Caution With Ayurvedic Products
The presence of heavy metals in some Ayurvedic products makes them potentially harmful. ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien) Recall due to mislabeling that could lead to incorrect insulin dosing. Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) See Web site for additional information. November 17, 2008Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator
Class I recall because of unsupported claims. Recalls and Safety Alerts: Serious Hypersensitivity Reactions with Abacavir (Ziagen) FDA is alerting healthcare professionals that certain patients are more likely to experience serious and potentially fatal hypersensitivity reactions when treated with the antiretroviral drug abacavir. Abacavir is sold under the trade name Ziagen an... Preventing Medical Errors: Tragic Events with Concentrated Opiate Oral Solutions An alert from the Institute for Safe Medication Practices warns about potentially fatal errors that can occur with concentrated oral opiate solutions. ISMP cites a recent case involving an 18 year old who was prescribed oxycodone oral solution to ... CSI USA, Inc. Issues Voluntary National Recall of Topical Acne Cream (November 13) CSI, USA, Inc. issued a voluntary nationwide consumer product recall of all lots of 1 ounce (28 g) tubes of 10 Percent Benzoyl Peroxide Acne Cream with the following names: "DG Maximum Strength Acne Medicated Gel" (sold at Dollar General); "Kroger Acne Gel 10 Percent Benzoyl Peroxide Acne Medication" (sold at Kroger); and "Equate: Medicated Acne Gel" (sold at Wal-Mart). Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24) Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. Johnson and Johnson--Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Non-Staining Due To Possible Metal Fragments (November 7) Johnson and Johnson -- Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately. Recalls and Safety Alerts: Increased Risk of Death in Elderly Patients Taking Conventional Antipsychotics for Dementia FDA is requiring that "conventional" antipsychotic drugs carry a boxed warning stating that these drugs increase the risk of death when they are used to treat dementia-related psychosis in elderly patients. This category includes such drugs as Haldo... Seattle's Favorite Gourmet Cookies and Dessert Co Issues Nationwide Allergy Alert on Undeclared Milk in Muffin Tops (November 14) Seattle's Favorite Gourmet Cookies and Dessert Co. is recalling Orange Cranberry and Banana Nut Muffin Tops because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life threatening allergic reaction if they consume these products. The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk (October 20) The Hartz Mountain Corporation, Secaucus, NJ is voluntarily recalling one specific lot of Hartz Chicken-Basted Rawhide Chips due to concerns that one or more bags within the lot are potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall. FDA notes pregnancy risks with Theravance drug - Forbes FDA notes pregnancy risks with Theravance drug - Forbes
Shares of drugmaker Theravance surged Monday on the release of a federal review of the company's experimental antibiotic, despite concerns about the product's risks to pregnant women. Cowen Co. analyst Rachel McMinn wrote in a research note the Food Source: www.forbes.com Raptiva (efalizumab) Raptiva (efalizumab)
Risk of life-threatening infections associated with Raptiva use. September 2008 Safety-Related Labeling Changes Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides. FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31. FDA Approves Toviaz, a New Drug to Treat Overactive Bladder The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB. FDA Warns Public of Extortion Scam by FDA Impersonators The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. FDA to open China offices after product scares - Ann Arbor News FDA to open China offices after product scares - Ann Arbor News
BEIJING (AP) — The U.S. Food and Drug Administration will open three offices in China this week in an unprecedented effort to improve the safety of exports headed to America amid recurring product safety scares. The new FDA offices, which are the Source: www.mlive.com United Therapeutics, Eli Lilly sign drug contract - Forbes Biotechnology company United Therapeutics Corp. said Monday it is licensing rights to sell Eli Lilly & Co.'s erectile dysfunction drug Cialis as a hypertension treatment in the U.S. United Therapeutics will pay Indianapolis-based Eli Lilly $150 Source: www.forbes.com US Food and Drug Administration to open China offices in effort to - In-Forum The U.S. Food and Drug Administration will open three offices in China this week in an unprecedented effort to improve the safety of exports headed to America amid recurring product safety scares. The new FDA offices, which are the first outside of Source: www.in-forum.com Mylan gets tentative FDA OK on antidepressant - MSN MoneyCentral PITTSBURGH (AP) - Mylan Inc. said Monday the Food and Drug Administration tentatively approved the drug developer's generic capsule version of Wyeth's antidepressant Effexor XR. Madison, N.J.-based Wyeth starts losing patent protection on that Source: news.moneycentral.msn.com US Food and Drug Administration to open China offices in effort to - Minneapolis Star Tribune W. Virginia town shrugs at poorest health ranking Study: Vitamins C, E do not prevent cancer in men How I got this body: Piling on the activities and friends The bloom of birth Grinding flaxseed is key to benefits BEIJING - The U.S. Food and Drug Source: www.startribune.com Cenomed BioSciences Presents Data on New Drug Candidates at the - MSN MoneyCentral Cenomed BioSciences, LLC, a majority-owned subsidiary of Abraxis BioScience, Inc. ABII , today announced the presentation of results of research was presented at the 38 th Annual Meeting of the Society for Neuroscience in Washington DC. This work has Source: news.moneycentral.msn.com United Therapeutics hypertension drug fails study - Forbes Biotechnology company United Therapeutics Corp. said Monday an oral sustained-release version of its hypertension drug Remodulin failed a late-stage study. Remodulin is already approved as an intravenous treatment and the Food and Drug Administration Source: www.forbes.com November 16, 2008Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva
FDA has received reports of serious infections leading to hospitalizations and deaths in people who use Raptiva. Dextroamphetamine Sulfate 5mg Tablets Drug recall due to the potential for oversized tablets that may be associated with an increased risk of adverse effects. September 2008 Safety-Related Labeling Changes Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides. Vaccines Stand Ready for Flu Season FDA has approved six vaccines for the 2008-2009 flu season. Outsmarting Poison Ivy and Other Poisonous Plants Poison ivy and other poisonous plants are a hazard all year round. Here are tips for preventing and treating the itchy rash and blisters. Why Howard Dean, MD, would be the best Health Secretary or FDA - OpEdNews.com Why Howard Dean, MD, would be the best Health Secretary or FDA - OpEdNews.com
Dr. Howard Dean III is the best candidate for FDA Commissioner. Further, I strongly support legislation elevating the FDA job to a Cabinet position, since, after all, it oversees in a regulatory capacity 25% of the US Economy, and as such, deserves Source: www.opednews.com IRIS International, Inc. Q3 2008 Earnings Call Transcript - Seekingalpha.com Good afternoon, and welcome, ladies and gentlemen, to the IRIS International Incorporated conference call for a discussion of the company's 2008 third quarter financial results. Moderating today's call are César Garcia, President and Chief Executive Source: seekingalpha.com The Goo (FDA), the Bad (wrinkle fillers), and the Ugly (930 users) - Itwire.com Officials with the Food and Drug Administration (FDA) report that the goo in wrinkle fillers can have ugly side effects including swelling, allergic reactions, infections, and even life-threatening complications. These injectable wrinkle fillers Source: www.itwire.com FDA Seizes Contaminated Heparin From A Cincinnati Manufacturer - Medical News Today As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio. The five lots of Heparin Sodium Source: www.medicalnewstoday.com BPA substitutes sought - Milwaukee Journal Sentinel Warning: Chemicals in the packaging, surfaces or contents of many products may cause long-term health effects, including cancers of the breast, brain and testicles; lowered sperm counts, early puberty and other reproductive system defects; diabetes Source: www.jsonline.com Place an Ad » - Blueridgenow.com DIGITAL Mammography and State of the Art Ultrasound We are proud to provide the women of our area with the most advanced digital mammography technology and one of the latest systems approved by FDA. We also offer state of the art ultrasound equipment Source: www.blueridgenow.com Some moms ditch plastic cups - Raleigh News & Observer Ian Ballard, 3, plays under the kitchen table after snack time in his Raleigh home. His plastic drink cup has been replaced with a stainless steel one. His mother, Kimberly, began removing products with BPA about a year ago. Bisphenol A is a chemical Source: www.newsobserver.com POLITICO's recent specious article saying that "Dean not a contender - OpEdNews.com I find this article to be totally specious, in fact no more than a corporate journalist's hatchet job! Not even qualifying or identifying the sources makes it more of a "run it up the flag pole and see who doesn't salute" kind of story, as such: bad Source: www.opednews.com Obama Expected to Render FDA Imports Monitoring Stricter - Eflux Media With Barack Obama having been elected the next president of the United States on November 4, Americans are now expecting to see him keep his promise of bringing the change that the nation needs. Currently, the Food and Drug Administration (FDA) is Source: www.efluxmedia.com FDA to detain food shipments from China - Atlanta Journal Constitution Federal health officials on Thursday ordered dozens of imported foods from China held at the border as possible health risks. Most are ethnic treats, including snacks, drinks and chocolates. It’s unusual for the Food and Drug Administration to put Source: www.ajc.com Johnson and Johnson--Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Non-Staining Due To Possible Metal Fragments (November 7) Johnson and Johnson--Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Non-Staining Due To Possible Metal Fragments (November 7)
Johnson and Johnson -- Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately. Improper Use of Decorative Contacts May Haunt You Halloween is a good time to remind people that improper use of non-prescription decorative contact lenses may harm your vision FDA Warns Bayer About Two Unapproved Aspirin Products FDA has sent warning letters to Bayer HealthCare regarding two over-the-counter products that combine aspirin with a dietary supplement into a single pill. Lotte USA, Inc. Initiates Nationwide Recall of Koala's March Creme filled Cookies Lotte USA, Inc., Battle Creek, MI initiated a recall of all Koalas' March Cookies on September 29, 2008 because they were produced in China and they may be contaminated with melamine. The products are packaged in a plastic overwrap. Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY Gourmet Sold at Wal-Mart locations in Fifteen States due to Potential Salmonella Contamination Mars Petcare US today announced a voluntary recall of a limited number of bags of SPECIAL KITTY Gourmet Blend dry cat food sold at Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia. The pet food is being voluntarily recalled following a positive test result indicating a potential contamination with Salmonella. Recalls and Safety Alerts: Serious Hypersensitivity Reactions with Abacavir (Ziagen) FDA is alerting healthcare professionals that certain patients are more likely to experience serious and potentially fatal hypersensitivity reactions when treated with the antiretroviral drug abacavir. Abacavir is sold under the trade name Ziagen an... FDA Requires Stronger Fungal Infection Warning for TNF Blockers FDA has told the makers of drugs known as "tumor necrosis factor alpha blockers" (TNF-alpha blockers) to strengthen existing labeling. Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk (October 20) The Hartz Mountain Corporation, Secaucus, NJ is voluntarily recalling one specific lot of Hartz Chicken-Basted Rawhide Chips due to concerns that one or more bags within the lot are potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall. Everlasting Distributors Inc. Issues a Nationwide Recall of Fresh and Crispy Jacobina Biscuits Because of Possible Health Risks (October 29) Everlasting Distributors Inc. Issues a Nationwide Recall of Fresh and Crispy Jacobina Biscuits Because of Possible Health Risks (October 29)
Everlasting Distributors Inc., Bayonne NJ is initiating a nationwide recall of all their 3.88oz (110gm) packages of Fresh and Crispy Jacobina Biscuits because it may be contaminated with Melamine. Preventing Medical Errors: Tragic Events with Concentrated Opiate Oral Solutions An alert from the Institute for Safe Medication Practices warns about potentially fatal errors that can occur with concentrated oral opiate solutions. ISMP cites a recent case involving an 18 year old who was prescribed oxycodone oral solution to ... CSI USA, Inc. Issues Voluntary National Recall of Topical Acne Cream (November 13) CSI, USA, Inc. issued a voluntary nationwide consumer product recall of all lots of 1 ounce (28 g) tubes of 10 Percent Benzoyl Peroxide Acne Cream with the following names: "DG Maximum Strength Acne Medicated Gel" (sold at Dollar General); "Kroger Acne Gel 10 Percent Benzoyl Peroxide Acne Medication" (sold at Kroger); and "Equate: Medicated Acne Gel" (sold at Wal-Mart). Recalls and Safety Alerts: Serious Fungal Infections with Humira, Cimzia, Enbrel and Remicade Recalls and Safety Alerts: Serious Fungal Infections with Humira, Cimzia, Enbrel and Remicade
The manufacturers of Humira (adalimumab), Cimzia (certolizumab pegol), Enbrel (etanercept), and Remicade (infliximab) must strengthen warnings about the risk of developing opportunistic fungal infections from these drugs. These infections have been ... FDA Warns Public of Extortion Scam by FDA Impersonators The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. Recalls and Safety Alerts: Updated Warning on Byetta In October 2007, FDA warned healthcare professionals about reports of acute pancreatitis in patients taking the antidiabetic drug Byetta (exenatide). Since then, FDA has received reports of six cases of hemorrhagic or necrotizing pancreatitis in pat... Preventing Medical Errors: Tragic Events with Concentrated Opiate Oral Solutions An alert from the Institute for Safe Medication Practices warns about potentially fatal errors that can occur with concentrated oral opiate solutions. ISMP cites a recent case involving an 18 year old who was prescribed oxycodone oral solution to ... Recalls and Safety Alerts: Serious Injection Site Reactions with Vivitrol FDA is alerting healthcare professionals about the risk of serious reactions at the injection site among patients treated with Vivitrol (naltrexone). Vivitrol is administered intramuscularly to treat alcohol dependence. FDA has received nearly ... FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31. |
Subscribe to Posts [Atom]