June 28, 2008Wrinkle Relief: Injectable Cosmetic Fillers Wrinkle Relief: Injectable Cosmetic Fillers
Injectable wrinkle fillers can restore a smoother appearance to your face, but here's what to consider before having this cosmetic procedure done. Stay Healthy While Traveling Abroad Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. Lake Country Lamb Feed Voluntary Recall (June 6) The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5) Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5)
Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. 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. FDA Approves Diaphragm-Pacing Device The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. Lake Country Lamb Feed Voluntary Recall (June 6) The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper. FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles. Did tomatoes cause Salmonella outbreak? - Daily Independent Did tomatoes cause Salmonella outbreak? - Daily Independent
WASHINGTON — As salmonella cases continue to climb, the government is checking if tainted tomatoes really are to blame for the record outbreak - or if the problem is with another ingredient, or a warehouse that is contaminating newly harvested Source: www.dailyindependent.com House committee criticizes FDA over bonuses - Salon Jun 26th, 2008 | WASHINGTON -- A review of bonuses paid to employees at the Food and Drug Administration showed many went to the agency's highest-paid staff rather than to the inspectors in the field, according to a review by the House Energy and Source: www.salon.com Baxter weighs whether to sell heparin vials again in U.S. market - Chicago Tribune Baxter weighs whether to sell heparin vials again in U.S. market - Chicago Tribune
Baxter International Inc. Chairman and Chief Executive Robert Parkinson is leaving open the possibility that the company may stay out of the business of selling vials of heparin in the U.S. market. The company recalled vials of the popular blood Source: www.chicagotribune.com House committee says FDA bonuses should go to inspectors, not highest - Minneapolis Star Tribune WASHINGTON - A review of bonuses paid to employees at the Food and Drug Administration showed many went to the agency's highest-paid staff rather than to the inspectors in the field, according to a review by the House Energy and Commerce Committee Source: www.startribune.com Did tomatoes cause Salmonella outbreak? - Daily Independent WASHINGTON — As salmonella cases continue to climb, the government is checking if tainted tomatoes really are to blame for the record outbreak - or if the problem is with another ingredient, or a warehouse that is contaminating newly harvested Source: www.dailyindependent.com Could Korean Leader Learn from Controversies over U.S. Beef Imports? - BusinessWeek At first blush, a delay in South Korea’s resumption of U.S. beef imports in the face of vociferous public protests may appear yet another instance of emotional nationalism in the way of a deal, which makes business sense. But although it certainly Source: www.businessweek.com Gay Blood Donors - WOKR 13 (Rochester, N.Y.) - Giving blood is one of the most honorable deeds a person can do. Claire Broomfiled feels it's her responsibility. “I’ve got something that someone else needs, and I'm happy to share it if I can do so,” she said. However, not Source: www.13wham.com Western Growers Asks for Congressional AG Committee Hearings Regarding - Forbes IRVINE, Calif., June 28 /PRNewswire-USNewswire/ -- Western Growers is urging the House Committee on Agriculture to hold hearings as soon as possible on the salmonella outbreak that has been associated with fresh, red round, roma and plum tomatoes Source: www.forbes.com Committee critical of FDA bonuses - Salon Jun 26th, 2008 | WASHINGTON -- A congressional review of bonuses paid to employees at the Food and Drug Administration showed many went to the highest-paid staff rather than to field inspectors. The chairman of the House committee that released the Source: www.salon.com House committee criticizes FDA over bonuses - Salon Jun 26th, 2008 | WASHINGTON -- A review of bonuses paid to employees at the Food and Drug Administration showed many went to the agency's highest-paid staff rather than to the inspectors in the field, according to a review by the House Energy and Source: www.salon.com Amgen osteoporosis drug could face FDA scrutiny - Forbes Amgen osteoporosis drug could face FDA scrutiny - Forbes
Amgen 's experimental osteoporosis drug denosumab could have difficulty gaining Food and Drug Administration approval in its initial try, due to a higher incidence of infections compared with placebo seen in some patients, according to an Source: www.forbes.com Could Korean Leader Learn from Controversies over U.S. Beef Imports? - BusinessWeek At first blush, a delay in South Korea’s resumption of U.S. beef imports in the face of vociferous public protests may appear yet another instance of emotional nationalism in the way of a deal, which makes business sense. But although it certainly Source: www.businessweek.com Committee critical of FDA bonuses - Seattle Post Intelligencer WASHINGTON -- A congressional review of bonuses paid to employees at the Food and Drug Administration showed many went to the highest-paid staff rather than to field inspectors. The chairman of the House committee that released the findings Thursday Source: seattlepi.nwsource.com UPDATE 2-UCB plans epilepsy drug launch in autumn, shares up - Reuters UK BRUSSELS, June 27 (Reuters) - Shares in UCB SA (UCB.BR: Quote , Profile , Research ) jumped on Friday after the Belgian pharmaceutical group said it aimed to launch its new epilepsy drug Vimpat in the autumn following European Medicines Agency Source: uk.reuters.com FDA Boosts Bonuses Despite Ongoing Criticism From Hill - Washington Post Resize Text The Food and Drug Administration increased bonuses to its employees by 29 percent in the past year, despite earlier objections from lawmakers. The FDA paid $35 million in staff incentives for the year ending April 12, up from $27.1 Source: www.washingtonpost.com House committee criticizes FDA over bonuses - BusinessWeek A review of bonuses paid to employees at the Food and Drug Administration showed many went to the agency's highest-paid staff rather than to the inspectors in the field, according to a review by the House Energy and Commerce Committee. Lawmakers were Source: www.businessweek.com Vanda falls as insomnia drug misses some goals - Forbes While biotechnology company Vanda Pharmaceuticals Inc. said Thursday a late-stage trial for an insomnia drug met its goal, the drug failed to show a long-term benefit compared with placebo, sending shares tumbling. In afternoon trading, Vanda shares Source: www.forbes.com Death-linked obesity drug - Sunday Herald AN ANTI-OBESITY drug implicated in the deaths of five people is being handed out to Scots in contravention of advice from medical authorities. Rimonabant - also known under the brand name Accomplia - has just been given the go-ahead for general use Source: www.sundayherald.com Tomatoes Return to Stores, Menus as California Begins Harvest - AG Weekly Tomatoes Return to Stores, Menus as California Begins Harvest - AG Weekly
FRESNO, Calif. (BUSINESS WIRE) - Just in time for the start of tomato harvest in major California production areas, restaurants and grocery stores are announcing the return of tomatoes to store shelves and menus. The move comes in light of Source: www.agweekly.com Cause of salmonella outbreak still not pinned down - Seattle Times Cause of salmonella outbreak still not pinned down - Seattle Times
WASHINGTON — As salmonella cases continue to climb, the government is checking if tainted tomatoes really are to blame for the record outbreak — or if the problem is with another ingredient, or a warehouse that is contaminating newly harvested Source: seattletimes.nwsource.com UPDATE 1-UCB wins EU green light for epilepsy drug - CNBC LONDON, June 26 (Reuters) - The European Medicines Agency has recommended approval of UCB's Tomatoes may be absolved - Traverse City Record-Eagle Tomatoes may be absolved - Traverse City Record-Eagle
WASHINGTON (AP) -- As salmonella cases continue to climb, the government is checking if tainted tomatoes really are to blame for the record outbreak -- or if the problem is with another ingredient, or a warehouse that is contaminating newly harvested Source: www.record-eagle.com Akorn-Strides gets FDA OKs for famotidine injection - CNBC BOSTON (Thomson Financial) - Akorn-Strides LLC, a joint venture of Akorn Inc. and Strides Arcolab Ltd., said Thursday it received Food and Drug Administration approval for its famotidine injection. The Buffalo Grove, Ill.-based therapeutic Source: www.cnbc.com Committee critical of FDA bonuses - Seattle Post Intelligencer WASHINGTON -- A congressional review of bonuses paid to employees at the Food and Drug Administration showed many went to the highest-paid staff rather than to field inspectors. The chairman of the House committee that released the findings Thursday Source: seattlepi.nwsource.com FDA Incentive Pay Jumps To $35 Million in 2007 - Wall Street Journal WASHINGTON -- The U.S. Food and Drug Administration awarded employees more than $35 million in incentive pay for fiscal year 2007, a 29% jump from the previous year despite cries from Congress that the agency's bonuses to senior officials are Source: online.wsj.com Tomato 'repacking' vexes salmonella trackers - San Francisco Gate A widespread practice of mixing tomatoes from different farms at produce distribution centers has made it impossible so far to trace the source of a nationwide salmonella outbreak that has sickened hundreds, federal regulators said Friday. Dr. David Source: www.sfgate.com House committee criticizes FDA over bonuses - Boston Globe WASHINGTON— A review of bonuses paid to employees at the Food and Drug Administration showed many went to the agency's highest-paid staff rather than to the inspectors in the field, according to a review by the House Energy and Commerce Committee Source: www.boston.com AspenBio Pharma Commences FDA Clinical Trial for AppyScore(TM - MSN MoneyCentral AspenBio Pharma, Inc. (NASDAQ: APPY) an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for humans and animals, has officially initiated a clinical trial to support the FDA 510(k) application for the Source: news.moneycentral.msn.com Committee critical of FDA bonuses - Forbes A congressional review of bonuses paid to employees at the Food and Drug Administration showed many went to the highest-paid staff rather than to field inspectors. The chairman of the House committee that released the findings Thursday said some Source: www.forbes.com Cause of salmonella outbreak still not pinned down - Seattle Times WASHINGTON — As salmonella cases continue to climb, the government is checking if tainted tomatoes really are to blame for the record outbreak — or if the problem is with another ingredient, or a warehouse that is contaminating newly harvested Source: seattletimes.nwsource.com Amgen osteoporosis drug could face FDA scrutiny - CNN Money NEW YORK (Associated Press) - Amgen's experimental osteoporosis drug denosumab could have difficulty gaining Food and Drug Administration approval in its initial try, due to a higher incidence of infections compared with placebo seen in some patients Source: money.cnn.com Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28) Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28)
Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk. This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7. Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. Lake Country Lamb Feed Voluntary Recall (June 6) The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper. FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles. Investigation goes beyond tomatoes - Baltimore Sun Investigation goes beyond tomatoes - Baltimore Sun
WASHINGTON - Investigators probing the Salmonella saintpaul outbreak that has sickened at least 810 Americans, including 25 in Maryland, are trying to make sure that tomatoes are the cause, an official of the Centers for Disease Control and Source: www.baltimoresun.com Feds question if tomatoes are to blame - Modesto Bee Police shoot, kill man who stomped baby to death Modesto man sentenced to a year in jail in son's death Modesto police lose suspect, kill pit bulls in his yard Ban on gay marriage needs non-religious basis Child's beating death 'too horrific' to Source: www.modbee.com Committee critical of FDA bonuses - Seattle Post Intelligencer WASHINGTON -- A congressional review of bonuses paid to employees at the Food and Drug Administration showed many went to the highest-paid staff rather than to field inspectors. The chairman of the House committee that released the findings Thursday Source: seattlepi.nwsource.com Amgen osteoporosis drug could face FDA scrutiny - Forbes Amgen osteoporosis drug could face FDA scrutiny - Forbes
Amgen 's experimental osteoporosis drug denosumab could have difficulty gaining Food and Drug Administration approval in its initial try, due to a higher incidence of infections compared with placebo seen in some patients, according to an Source: www.forbes.com Tomatoes not alone on FDA's radar - Detroit Free Press WASHINGTON -- As salmonella cases continue to climb, the government is investigating whether tainted tomatoes really are to blame for the record outbreak -- or if the problem is with another ingredient or a warehouse that is contaminating newly Source: www.freep.com Critics blast feds' legal shields for manufacturers - Chicago Tribune WASHINGTON — Bridget Robb's 6-year-old daughter watched fearfully one morning last December as her mother nearly passed out in pain. A wire that connected a defibrillator in Robb's chest had broken, causing it to send waves of powerful electric Source: www.chicagotribune.com AspenBio Pharma Commences FDA Clinical Trial for AppyScore(TM - MSN MoneyCentral AspenBio Pharma, Inc. (NASDAQ: APPY) an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for humans and animals, has officially initiated a clinical trial to support the FDA 510(k) application for the Source: news.moneycentral.msn.com Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23)
Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13) ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between June 2006 and May 2008. Lake Country Lamb Feed Voluntary Recall (June 6) The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper. Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28) Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk. This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7. FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (May 16) The U.S. Food and Drug Administration directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007. Recalls and Safety Alerts: FDA Studying Potential Safety Issues with Several Drugs FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because this information... Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18) Matterhorn Group Inc is recalling certain date coded product of their Rainbow Glacier "Astro Pops" water ice frozen novelty pops, Cherry Pineapple Swirl 3.5 oz size 12 count bag pack, with tag closure "Best by JUN 03-09", "Best by JUN 04-09" and "Best by JUN 05-09" sold through the Wal-Mart stores located in California and Arizona, Sunnyside Farms "Missile Pops" Cherry Pineapple in 3.5 oz. size 12 count bag packages, with tag closure of "Best By JUN 02-09", "Best by JUN 03-09", and "Best by JUN 04-09" sold through the California stores of grocery retailers Save Mart and Raley’s, and Vitafreze Frozen Astronot Pops 3.5 oz size 12 count bag packages, with tag closure of "Best By JUN 02-09" sold in California. The products are being recalled because they may contain pieces of hard plastic. Only the noted product date codes listed are affected. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. June 27, 2008FDA Approves Diaphragm-Pacing Device FDA Approves Diaphragm-Pacing Device
The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. FDA Takes Action against Seafood Processing Company, Executives The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act. FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. Red Tomato Warning Expanded Nationwide The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these tomatoes. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Contaminated Nipple Cream FDA is warning nursing mothers not to buy or use Mommy's Bliss Nipple Cream because it contains potentially harmful ingredients. FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28) Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk. This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7. Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release) HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA. International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29) International Pharmaceuticals, Ltd., announced that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving. FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. Recall of Nestle Pure Life Purified Water (June 24) This announces a product recall for the one-gallon Nestle Pure Life Purified Drinking Water sold ONLY in Shop-Rite stores in the five Northeast states of Connecticut, Delaware, New Jersey, New York and Pennsylvania. This affects ONLY the one-gallon size. Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions US checks if tomatoes caused Salmonella outbreak - Forbes US checks if tomatoes caused Salmonella outbreak - Forbes
As salmonella cases continue to climb, the government is checking if tainted tomatoes really are to blame for the record outbreak - or if the problem is with another ingredient, or a warehouse that is contaminating newly harvested tomatoes. The Source: www.forbes.com Barr Pharmaceuticals spent $1.7M lobbying in 1Q - Forbes Generic drug maker Barr Pharmaceuticals Inc. spent nearly $1.7 million in the first quarter lobbying on legislation affecting the drug industry, according to a recent disclosure form. The Montvale, N.J.-based company lobbied on several bills related Source: www.forbes.com Committee critical of FDA bonuses - Seattle Post Intelligencer WASHINGTON -- A congressional review of bonuses paid to employees at the Food and Drug Administration showed many went to the highest-paid staff rather than to field inspectors. The chairman of the House committee that released the findings Thursday Source: seattlepi.nwsource.com Centocor seeks OK for new arthritis drug - Philadelphia Business Journal Centocor Inc. filed a biologics license application with the Food and Drug Administration Friday seeking approval for its new drug candidate golimumab as a treatment for three conditions: rheumatoid arthritis, psoriatic arthritis and ankylosing Source: philadelphia.bizjournals.com Health Winners & Losers: Exelixis - Street.Com Health stocks closed out the week on a bright note, outperforming the broader markets Friday and airing scattered business, regulatory and clinical news. Exelixis EXEL and GlaxoSmithKline GSK said early Friday that they will not extend their cancer Source: www.thestreet.com Painkiller Deemed Dangerous by Advocacy Group - HULIQ.com Some painkillers may do more harm than good. Public Citizen, a consumer advocacy group, is pushing the U.S. Food and Drug Administration (FDA) to ban a prescription painkiller chemically known as propoxyphene, citing the dangerous risks it poses to Source: www.huliq.com U.S. tomato-linked salmonella illnesses surpass 800 - Reuters WASHINGTON (Reuters) - The number of people sickened in a salmonella outbreak linked to certain tomatoes has topped 800 as U.S. investigators continue to try to pinpoint the source of the contamination. The U.S. Centers for Disease Control and Source: www.reuters.com Barr shares rise on Mirapex patent case victory - MSN MoneyCentral NEW YORK (AP) - Shares of Barr Pharmaceuticals Inc. rose Friday as a Delaware federal court invalidated several patents covering Boehringer Ingelheim Pharmaceuticals Inc.'s Mirapex, opening the door for a generic launch. Barr shares rose $1.15, or 2 Source: news.moneycentral.msn.com Foodservice group spent $172,442 lobbying in 1Q - CNBC WASHINGTON - The International Foodservice Distributors Association spent $172,442 in the first quarter to lobby an increase in the minimum wage, agriculture and energy legislation, and other issues. The trade group, whose members include Sysco Corp Source: www.cnbc.com UPDATE 2-Merck, Schering end combo respiratory drug bid - Reuters NEW YORK, June 27 (Reuters) - Merck & Co Inc (MRK.N: Quote , Profile , Research , Stock Buzz ) and Schering-Plough Corp (SGP.N: Quote , Profile , Research , Stock Buzz ) said on Friday they withdrew their U.S. application for combining their Source: www.reuters.com FDA 101: How to Use the Consumer Complaint System and MedWatch FDA 101: How to Use the Consumer Complaint System and MedWatch
When you have a problem with a food, drug, or other FDA-regulated product, FDA wants to hear from you. Here's how to report problems using two of FDA's main reporting systems. Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5) Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. 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. International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29) International Pharmaceuticals, Ltd., announced that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving. Updated Press Release: Lake Country and LAND O LAKES Lamb Feed Voluntary Recall The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of four lamb feed products, packaged in 50-pound bags, due to the potential for higher than acceptable levels of copper. On National HIV Testing Day Chembio Reports Completion of Pediatric - MSN MoneyCentral On National HIV Testing Day Chembio Reports Completion of Pediatric - MSN MoneyCentral
Chembio Diagnostics, Inc. (OTCBB: CEMI) ("Chembio" or the "Company") reported today, National HIV Testing Day, that it has completed a clinical study designed to evaluate the performance of its two FDA (United States Food & Drug Administration Source: news.moneycentral.msn.com Centocor, Inc. Submits BLA to FDA for Golimumab in the Treatment of - Phramalive.com Extensive Clinical Development Program Investigating Golimumab in the Treatment of These Diseases Serves as Basis for the Application HORSHAM, Pa., June 27, 2008 /PRNewswire/ -- Centocor, Inc. announced today that a Biologics License Application (BLA Source: www.pharmalive.com House committee criticizes FDA over bonuses - BusinessWeek A review of bonuses paid to employees at the Food and Drug Administration showed many went to the agency's highest-paid staff rather than to the inspectors in the field, according to a review by the House Energy and Commerce Committee. Lawmakers were Source: www.businessweek.com Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection.
Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) FDA investigating TNF blockers and cancer risk in children and young adults. Drug Shortage: MVI Adult Injectable Hospira information updated. Viril-ity Power (VIP) Tablets Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. February 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Recalls and Safety Alerts: Avoid Using ReadyMED Infusion Pumps with Cubicin In an April 4, 2008 letter, Cubist Pharmaceuticals advised healthcare professionals not to use the drug Cubicin with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health. Cubicin (daptomycin for injection) is an antibiotic used to tre... June 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. UPDATE 2-Merck, Schering end combo respiratory drug bid - Reuters UPDATE 2-Merck, Schering end combo respiratory drug bid - Reuters
NEW YORK, June 27 (Reuters) - Merck & Co Inc (MRK.N: Quote , Profile , Research , Stock Buzz ) and Schering-Plough Corp (SGP.N: Quote , Profile , Research , Stock Buzz ) said on Friday they withdrew their U.S. application for combining their Source: www.reuters.com Merck, Schering end combo respiratory drug bid - Guardian Unlimited NEW YORK, June 27 (Reuters) - Merck & Co Inc and Schering-Plough Corp said on Friday they withdrew their U.S. application for combining their blockbuster allergy drugs Singulair and Claritin into one pill, and ended an eight-year joint effort on the Source: www.guardian.co.uk UPDATE 2-UCB plans epilepsy drug launch in autumn, shares up - Reuters BRUSSELS, June 27 (Reuters) - Shares in UCB SA (UCB.BR: Quote , Profile , Research , Stock Buzz ) jumped on Friday after the Belgian pharmaceutical group said it aimed to launch its new epilepsy drug Vimpat in the autumn following European Medicines Source: www.reuters.com FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety
In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity. Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release) HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial CDC: Salmonella-Tainted Tomato Illnesses Rise to 756 - FOX News CDC: Salmonella-Tainted Tomato Illnesses Rise to 756 - FOX News
That's roughly 200 more illnesses than health officials had counted a week ago, in what has become the nation's largest-ever outbreak of salmonella from tomatoes. The continuing rise in cases is due mostly to state laboratories finishing backlogs of Source: www.foxnews.com Aethlon Medical Featured in Medical Device Daily - MSN MoneyCentral Aethlon Medical is the developer of the Hemopurifier ® , a first-in-class medical device designed to treat infectious disease. The Hemopurifier ® provides real-time therapeutic filtration of infectious viruses and immunosuppressive particles, and Source: news.moneycentral.msn.com FDA Boosts Bonuses Despite Ongoing Criticism From Hill - Washington Post Resize Text The Food and Drug Administration increased bonuses to its employees by 29 percent in the past year, despite earlier objections from lawmakers. The FDA paid $35 million in staff incentives for the year ending April 12, up from $27.1 Source: www.washingtonpost.com 'Trust Drug' Oxytocin Unbelievable For Now - ABC News 'Trust Drug' Oxytocin Unbelievable For Now - ABC News
Normally, this would not be a problem. Zak, a professor of economics and the founding director of the Center for Neuroeconomics Studies at Claremont Graduate University in Claremont, Calif., is generally happy to talk about his research, which Source: www.abcnews.go.com PanGenex (PGXC) Releases Shareholder and Operational Update - Forbes PanGenex Corporation (Pink Sheets: PGXC), a publicly traded company, pursues business opportunities in the $70 billion dollar nutraceutical and dietary supplement industry. With a focus on the cardiovascular health segment, PanGenex develops and Source: www.forbes.com Ranbaxy Gains Tentative Approval to Manufacture and Market - Forbes PRINCETON, N.J., June 25 /PRNewswire/ -- Ranbaxy Laboratories Limited (RLL), announced today that the company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Valganciclovir Hydrochloride Tablets Source: www.forbes.com FDA: Merck can't market Gardasil to women 27-45 - Newsday NEWARK, N.J. - Drug maker Merck says the Food and Drug Administration has rejected expanding the use of cervical cancer vaccine Gardasil to include women ages 27 to 45. The agency cited "issues that preclude approval" within the expected review Source: www.newsday.com House committee criticizes FDA over bonuses - Boston Globe WASHINGTON— A review of bonuses paid to employees at the Food and Drug Administration showed many went to the agency's highest-paid staff rather than to the inspectors in the field, according to a review by the House Energy and Commerce Committee Source: www.boston.com Medicines hopeful on drug patent extension - MSN MoneyCentral NEW YORK (AP) - Drug developer Medicines Co. could gain a patent extension on its blood thinner product Angiomax, following a measure by the House of Representatives earlier this week. In a Securities and Exchange Commission filing Tuesday, the Source: moneycentral.msn.com UPDATE 3-UCB to launch epilepsy drug in autumn, shares up - Reuters BRUSSELS, June 27 (Reuters) - Shares in UCB SA (UCB.BR: Quote , Profile , Research , Stock Buzz ) jumped on Friday as the Belgian pharmaceutical group said it aimed to launch its new epilepsy drug Vimpat in the autumn, after winning a green light Source: www.reuters.com Quark Pharmaceuticals Receives FDA Approval of IND for Kidney - Forbes FREMONT, Calif., June 25 /PRNewswire/ -- Quark Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application for its siRNA drug candidate, DGFi, in kidney Source: www.forbes.com Vaccine help for kids on the way - Chicago Sun-Times ATLANTA -- A federal advisory panel on Thursday endorsed two new combination vaccines designed to reduce the number of needle sticks that young children must endure to get the recommended immunizations. The panel gave its nod to a four-in-one shot Source: www.suntimes.com June 26, 2008Albuterol Inhalers: Time to Transition Albuterol Inhalers: Time to Transition
Manufacturers have been directed to phase out albuterol inhalers that use chlorofluorocarbons (CFCs)--propellants that deplete the ozone layer. Here are facts about switching to alternative inhalers that use hydrofluoroalkane (HFA) propellants. Red Tomato Warning Expanded Nationwide The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these tomatoes. Spring 2008 Drug Safety Newsletter DSN provides information for healthcare professionals and the medical community about findings of selected post-marketing drug safety reviews, important emerging drug safety issues, and recently approved new molecular entities. June 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. Warning on Certain Types of Raw Red Tomatoes FDA is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. Contaminated Nipple Cream FDA is warning nursing mothers not to buy or use Mommy's Bliss Nipple Cream because it contains potentially harmful ingredients. GlaxoSmithKline says FDA approves KINRIX combination vaccine for - CNBC GlaxoSmithKline says FDA approves KINRIX combination vaccine for - CNBC
PHILADELPHIA (Thomson Financial) - GlaxoSmithKline said the U.S. Food and Drug Administration (FDA) has approved KINRIX, a combination vaccine for children against diphtheria, tetanus, pertussis and polio diseases. Clinical studies of KINRIX have Source: www.cnbc.com FDA OKs GlaxoSmithKline kids' combination vaccine - CNBC PHILADELPHIA - GlaxoSmithKline PLC said Wednesday it won Food and Drug Administration approval for a combination vaccine to protect children against diphtheria, tetanus, pertussis and polio. Glaxo said the vaccine, Kinrix, is the first to combine Source: www.cnbc.com Salmonella outbreak illnesses rise to 756 - Reuters WASHINGTON (Reuters) - More than 750 people have become ill in an outbreak of Salmonella linked to certain types of tomatoes, U.S food safety officials said on Thursday. The U.S. Centers for Disease Control and Prevention said 756 people in 34 states Source: www.reuters.com Merck Gets Dealt FDA Setback On Gardasil Marketing - CNN Money Merck & Co. (MRK) ran into a rare roadblock for its blockbuster cervical- cancer vaccine Gardasil when the Food and Drug Administration put off a decision on allowing sales to older women. The FDA denied the pharmaceutical giant's supplemental Source: money.cnn.com FDA won't clear expanded Merck cancer vaccine use - Reuters NEW YORK (Reuters) - U.S. regulators did not approve Merck & Co's application to expand marketing of its cervical cancer vaccine Gardasil to an older group of women within an expected review period, the drugmaker said on Wednesday. Merck had applied Source: www.reuters.com GlaxoSmithKline says FDA approves KINRIX combination vaccine for - Forbes PHILADELPHIA (Thomson Financial) - GlaxoSmithKline said the U.S. Food and Drug Administration (FDA) has approved KINRIX, a combination vaccine for children against diphtheria, tetanus, pertussis and polio diseases. Clinical studies of KINRIX have Source: www.forbes.com Committee critical of FDA bonuses - Seattle Post Intelligencer WASHINGTON -- A congressional review of bonuses paid to employees at the Food and Drug Administration showed many went to the highest-paid staff rather than to field inspectors. The chairman of the House committee that released the findings Thursday Source: seattlepi.nwsource.com FDA blocks expanded indication for Merck's Gardasil - Boston Globe WHITEHOUSE STATION, N.J.— Merck & Co. said Wednesday the Food and Drug Administration rejected expanding the use of cervical cancer vaccine Gardasil to include women ages 27 to 45, citing "issues that preclude approval" within the expected review Source: www.boston.com The FDA's Latest Victim - Motley Fool The FDA just can't seem to approve anything these days. Earlier in the week, the agency delayed Eli Lilly 's (NYSE: LLY ) heart drug, prasugrel. Now, Merck (NYSE: MRK ) says it'll have to wait for a label change to its already-approved human Source: www.fool.com FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. June 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Drug to be Discontinued: Kemadrin (procyclidine hydrochloride) Kemadrin (procyclidine hydrochloride), Dear Healthcare Professional Letter available for more information. Viril-ity Power (VIP) Tablets Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Drug Shortage: Digitek (digoxin tablets, USP) Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed on the Drug Shortage website. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. Morphine Sulfate 60 mg Extended Release Tablets Voluntarily recall of a single lot (No. 91762) due to a report of a tablet with twice the appropriate thickness. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again Spring 2008 Drug Safety Newsletter DSN provides information for healthcare professionals and the medical community about findings of selected post-marketing drug safety reviews, important emerging drug safety issues, and recently approved new molecular entities. FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'
Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. FDA Announces New Labeling Changes for Regranex The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01 percent (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients. Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. FDA Approves Diaphragm-Pacing Device The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. CDC Survey Shows a Decade of Progress in Reducing High School Smoking - Forbes CDC Survey Shows a Decade of Progress in Reducing High School Smoking - Forbes
WASHINGTON, June 26 /PRNewswire-USNewswire/ -- The latest survey of high school smoking rates, released today by the U.S. Centers for Disease Control and Prevention (CDC), shows that while the nation has made remarkable progress in reducing youth Source: www.forbes.com United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release) United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release)
U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People�s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety. Medicis Announces Voluntary Recall of Solodyn (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up (May 16) Medicis announced that the company is voluntarily recalling lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of the antibiotic SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg, 30-count bottles (NDC 99207-461-30). Medicis has received a report that one bottle in lot number B080037 contains AZASAN (azathioprine tablets) 75 mg (NDC 65649-231-51) instead of SOLODYN (minocycline HCl, USP) Extended Release Tablets, 90 mg. Pregnant Women to Benefit from Better Information A proposed rule will give women and their health care professionals better information concerning the effects of medications taken during pregnancy or while breastfeeding. Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. Morphine Sulfate 60 mg Extended Release Tablets Morphine Sulfate 60 mg Extended Release Tablets
Voluntarily recall of a single lot (No. 91762) due to a report of a tablet with twice the appropriate thickness. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Albuterol Inhalers: Time to Transition Manufacturers have been directed to phase out albuterol inhalers that use chlorofluorocarbons (CFCs)--propellants that deplete the ozone layer. Here are facts about switching to alternative inhalers that use hydrofluoroalkane (HFA) propellants. Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18) Matterhorn Group Inc is recalling certain date coded product of their Rainbow Glacier "Astro Pops" water ice frozen novelty pops, Cherry Pineapple Swirl 3.5 oz size 12 count bag pack, with tag closure "Best by JUN 03-09", "Best by JUN 04-09" and "Best by JUN 05-09" sold through the Wal-Mart stores located in California and Arizona, Sunnyside Farms "Missile Pops" Cherry Pineapple in 3.5 oz. size 12 count bag packages, with tag closure of "Best By JUN 02-09", "Best by JUN 03-09", and "Best by JUN 04-09" sold through the California stores of grocery retailers Save Mart and Raley’s, and Vitafreze Frozen Astronot Pops 3.5 oz size 12 count bag packages, with tag closure of "Best By JUN 02-09" sold in California. The products are being recalled because they may contain pieces of hard plastic. Only the noted product date codes listed are affected. Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5) Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. 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. International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29) International Pharmaceuticals, Ltd., announced that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving. GE Healthcare Tells FDA Panel Heart Imaging Agents Are Safe - CNN Money GE Healthcare Tells FDA Panel Heart Imaging Agents Are Safe - CNN Money
SILVER SPRING, Md. -(Dow Jones)- Medical companies, including GE Healthcare, and doctors on Tuesday told a U.S. Food and Drug Administration panel ultrasound heart-imaging agents are safe. Heart-imaging agents, or contrasting agents, remain a concern Source: money.cnn.com Tainted tomato cases soar - Atlanta Journal Constitution The number of Americans sickened by salmonella-contaminated tomatoes has soared to 707, making it the largest outbreak connected to the crop since the Centers for Disease Control and Prevention started keeping records in the 1960s. The actual number Source: www.ajc.com CDC Immunization Advisory Committee Recommends Two New Pediatric - Earthtimes -- GSK's ROTARIX(R) [Rotavirus Vaccine, Live, Oral] recommended for routine vaccination of infants to protect against rotavirus gastroenteritis (RGE) -- ROTARIX, approved by the FDA on April 3, 2008 , is the only rotavirus vaccine that offers Source: www.earthtimes.org FDA Takes Heat on Employee Bonuses - Wall Street Journal In 2004, Congress expanded a government bonus system to help stem the flow of skilled government workers heading for higher-paid jobs in the private sector. Now, at least one congressman is questioning the FDA’s use of the money. Figures released Source: blogs.wsj.com FDA delays decision on Eli Lilly blood clot drug - Forbes Eli Lilly shares hit a new 52-week low Tuesday, a day after the company announced the Food and Drug Administration needed three more months to review its blood thinner drug. The FDA did not ask for new clinical trials, but company spokeswoman Tammy Source: www.forbes.com The latest safety tips on eating tomatoes - Newsday The latest safety tips on eating tomatoes - Newsday
Avoid raw red plum, red Roma or red round tomatoes unless they were grown in specific states or countries that the Food and Drug Administration has cleared of suspicion. Check the Web site www.fda.gov for an updated list. Also safe are grape tomatoes Source: www.newsday.com Salmonella can ride water into tomatoes - Monterey County Herald Mark Roh, U.S. Food and Drug Administration's acting regional director holds a bag of tomatoes being tested for salmonella bacteria at FDA's southwest regional research lab in Irvine. WASHINGTON — Pick a tomato in the blazing sun and plunge it Source: www.montereyherald.com Sirion Therapeutics Announces FDA Approval of Durezol(TM) for - PR Newswire TAMPA, Fla., June 24 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved its new drug application for Durezol(TM Source: sev.prnewswire.com FDA delays decision on Eli Lilly blood clot drug - Forbes Eli Lilly shares hit a new 52-week low Tuesday, a day after the company announced the Food and Drug Administration needed three more months to review its blood thinner drug. The FDA did not ask for new clinical trials, but company spokeswoman Tammy Source: www.forbes.com Ranbaxy gets U.S. FDA approval to make, market Valganciclovir HCI - Forbes MUMBAI (Thomson Financial) - India's Ranbaxy Laboratories Ltd. said it received approval from the United States Food and Drug Administration to manufacture and market Valganciclovir HCI tablets, used in the treatment of cytomegalovirus (CMV Source: www.forbes.com Briefs: Nokia Buys Software Maker; Detroit Newspapers Offering Buyouts - The Ledger Nokia Corp. is buying the consortium that makes the software for its phones and making it available for free to other manufacturers, in hopes of blunting the influence of competing software providers. Nokia said Tuesday that it is offering to buy the Source: www.theledger.com Water In Tomatoes Can Be A Breeding Ground for Salmonella - Redorbit.com As the Food and Drug Administration investigates a national salmonella outbreak, researchers are finding the farm isn't the only place tomatoes are contaminated. Something as simple as washing a tomato can make it susceptible to both bacteria and Source: www.redorbit.com FDA delays decision on Eli Lilly blood clot drug - NWI.com INDIANAPOLIS - Eli Lilly shares hit a new 52-week low Tuesday, a day after the company announced the Food and Drug Administration needed three more months to review its blood thinner drug. The FDA did not ask for new clinical trials, but company Source: www.thetimesonline.com GlaxoSmithKline says FDA approves KINRIX combination vaccine for - Forbes GlaxoSmithKline says FDA approves KINRIX combination vaccine for - Forbes
PHILADELPHIA (Thomson Financial) - GlaxoSmithKline said the U.S. Food and Drug Administration (FDA) has approved KINRIX, a combination vaccine for children against diphtheria, tetanus, pertussis and polio diseases. Clinical studies of KINRIX have Source: www.forbes.com FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs
The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. Heartworm Prevention in Your Pet A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. Enforcement Actions for Food Safety Violations In separate enforcement actions, FDA shuts down companies for food safety violations. These actions include a recall of certain smoked seafood products. FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity. FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection.
Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) FDA investigating TNF blockers and cancer risk in children and young adults. February 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Patients Are Asking: Getting the Most Out of Blood Glucose Meters Keeping glucose levels under control can help people with diabetes feel better and also lower the risk of blindness, kidney disease, and nerve damage. Very high or very low blood sugar can have serious consequences. Although blood glucose meter... Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. Morphine Sulfate 60 mg Extended Release Tablets Voluntarily recall of a single lot (No. 91762) due to a report of a tablet with twice the appropriate thickness. Drug Shortage: Digitek (digoxin tablets, USP) Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed on the Drug Shortage website. Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28) Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28)
Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk. This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7. FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'
Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Beware of Online Cancer Fraud FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice. Warning on Certain Types of Raw Red Tomatoes FDA is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. Spring 2008 Drug Safety Newsletter DSN provides information for healthcare professionals and the medical community about findings of selected post-marketing drug safety reviews, important emerging drug safety issues, and recently approved new molecular entities. Albuterol Inhalers: Time to Transition Manufacturers have been directed to phase out albuterol inhalers that use chlorofluorocarbons (CFCs)--propellants that deplete the ozone layer. Here are facts about switching to alternative inhalers that use hydrofluoroalkane (HFA) propellants. June 25, 2008FDA delays decision on Eli Lilly blood clot drug - CNN Money FDA delays decision on Eli Lilly blood clot drug - CNN Money
NEW YORK (Associated Press) - Eli Lilly and Co. said late Monday the Food and Drug Administration will take an extra three months to review its application for the blood thinning drug prasugrel. Lilly and its Japanese partner Daiichi Sankyo Co. are Source: money.cnn.com FDA stalls Lilly's coronary drug - CNN Money INDIANAPOLIS (AP) -- Eli Lilly and Co. said late Monday the Food and Drug Administration will take an extra three months to review its application for the blood thinning drug prasugrel. Lilly ( LLY , Fortune 500 ) and its Japanese partner Daiichi Source: money.cnn.com FDA OKs GlaxoSmithKline kids' combination vaccine - CNN Money NEW YORK (Associated Press) - GlaxoSmithKline PLC said Wednesday it won Food and Drug Administration approval for a combination vaccine to protect children against diphtheria, tetanus, pertussis and polio. Glaxo said the vaccine, Kinrix, is the first Source: money.cnn.com FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative - MSN MoneyCentral Companies confirm the start of TRILOGY ACS clinical trial to study Prasugrel against Clopidogrel in medically managed ACS patients TOKYO and INDIANAPOLIS, June 23 /PRNewswire-FirstCall/ -- Daiichi Sankyo Company, Limited, 4568 and Eli Lilly and Source: news.moneycentral.msn.com FDA calls for seizure of pet food from PETCO Illinois distribution - Detroit News U.S. Marshals have seized animal food products allegedly stored under unsanitary conditions at a PETCO supplies distribution center in Joliet, Ill., U.S. Food and Drug Administration officials said in an alert Monday. Widespread rodent and bird Source: www.detnews.com FDA: Merck can’t expand market for cervical cancer vaccine - Philadelphia Inquirer NEWARK, N.J. - Drug maker Merck & Co. said today that the Food and Drug Administration has rejected expanding the use of cervical cancer vaccine Gardasil to include women age 27 to 45. The agency cited "issues that preclude approval" within the Source: www.philly.com FDA Extends Review Of Daiichi-Lilly Drug Prasugrel For 3 Months - CNN Money Daiichi Sankyo Co. (9130.TO) of Japan and Eli Lilly & Co. (LLY) said the Food and Drug Administration extended the review period three months for their anti- clotting drug prasugrel. The FDA is expected to act by Sept. 26 . Lilly's shares were at $47 Source: money.cnn.com FDA Incentive Pay Jumps To $35 Million in 2007 - Wall Street Journal FDA Incentive Pay Jumps To $35 Million in 2007 - Wall Street Journal
WASHINGTON -- The U.S. Food and Drug Administration awarded employees more than $35 million in incentive pay for fiscal year 2007, a 29% jump from the previous year despite cries from Congress that the agency's earlier bonuses to senior officials Source: online.wsj.com FDA calls for seizure of pet food from PETCO Illinois distribution - Detroit News U.S. Marshals have seized animal food products allegedly stored under unsanitary conditions at a PETCO supplies distribution center in Joliet, Ill., U.S. Food and Drug Administration officials said in an alert Monday. Widespread rodent and bird Source: www.detnews.com FDA Announces New Labeling Changes for Regranex FDA Announces New Labeling Changes for Regranex
The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01 percent (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release) HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA. FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. FDA 101: How to Use the Consumer Complaint System and MedWatch When you have a problem with a food, drug, or other FDA-regulated product, FDA wants to hear from you. Here's how to report problems using two of FDA's main reporting systems. Contaminated Nipple Cream FDA is warning nursing mothers not to buy or use Mommy's Bliss Nipple Cream because it contains potentially harmful ingredients. Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Stay Healthy While Traveling Abroad Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. Recalls and Safety Alerts: Inflammatory Masses with Synchromed and IsoMed Implantable Infusion Pumps Recalls and Safety Alerts: Inflammatory Masses with Synchromed and IsoMed Implantable Infusion Pumps
On January 16, 2008, Medtronic notified healthcare professionals about an increased rate of inflammatory masses in patients receiving intrathecal drugs through the company's Synchromed EL, Synchromed II and IsoMed implantable infusion pump systems. ... FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17) Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. Beware of Online Cancer Fraud FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice. ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13) ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between June 2006 and May 2008. Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12) Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate. FDA Approves Diaphragm-Pacing Device FDA Approves Diaphragm-Pacing Device
The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. Red Tomato Warning Expanded Nationwide The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these tomatoes. FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. Warning for Regranex—Cream for Leg and Foot Ulcers A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. How to Dispose of Unused Medicines How to Dispose of Unused Medicines
Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5) Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. 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. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28) Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk. This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7. How to Dispose of Unused Medicines How to Dispose of Unused Medicines
Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP) Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information. Drug Shortage: Fentanyl transdermal patch Availability information updated. Contaminated Nipple Cream FDA is warning nursing mothers not to buy or use Mommy's Bliss Nipple Cream because it contains potentially harmful ingredients. Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) FDA investigating TNF blockers and cancer risk in children and young adults. Warning for Regranex—Cream for Leg and Foot Ulcers A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. Drug Shortage: Digitek (digoxin tablets, USP) Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed on the Drug Shortage website. FDA won't clear expanded Merck cancer vaccine use - Reuters FDA won't clear expanded Merck cancer vaccine use - Reuters
NEW YORK (Reuters) - U.S. regulators did not approve Merck & Co's application to expand marketing of its cervical cancer vaccine Gardasil to an older group of women within an expected review period, the drugmaker said on Wednesday. Merck had applied Source: www.reuters.com US searches for salmonella in Mexico - Miami Herald U.S. Department of Health and Human Services Secretary Michael Leavitt gestures during an interview in Mexico City, Monday, June 23, 2008. Leavitt says the US is trying to open an FDA office in Latin America to check food safety, as U.S. inspectors Source: www.miamiherald.com Wider use of Merck's Gardasil nixed by FDA - MSN MoneyCentral The Food and Drug Administration rejected Merck and Co. Inc.'s application to expand the use of Gardasil, the company's cervical cancer vaccine, to include women ages 27 to 45. According to Merck, the federal agency had questions about the data Source: news.moneycentral.msn.com FDA: Merck can't market Gardasil to women 27-45 - CNN Money NEW YORK (Associated Press) - The drugmaker Merck said Wednesday the Food and Drug Administration has rejected expanding the use of cervical cancer vaccine Gardasil to include women ages 27 to 45. The agency cited "issues that preclude approval Source: money.cnn.com FDA Rejects Expanded Gardasil Use - Wall Street Journal Merck & Co. Inc. ran into a rare roadblock for its blockbuster cervical-cancer vaccine Garasil when the Food and Drug Administration put off a decision on allowing sales to older women. The FDA denied the pharmaceutical giant's supplemental request Source: online.wsj.com Merck Gets Dealt FDA Setback On Gardasil Marketing - CNN Money Merck & Co. (MRK) ran into a rare roadblock for its blockbuster cervical- cancer vaccine Gardasil when the Food and Drug Administration put off a decision on allowing sales to older women. The FDA denied the pharmaceutical giant's supplemental Source: money.cnn.com FDA delays decision on Eli Lilly blood clot drug - BusinessWeek Eli Lilly and Co. said late Monday the Food and Drug Administration will take an extra three months to review its application for the blood thinning drug prasugrel. Lilly and its Japanese partner Daiichi Sankyo Co. are aiming to gain approval of Source: www.businessweek.com The latest safety tips on eating tomatoes - Newsday Avoid raw red plum, red Roma or red round tomatoes unless they were grown in specific states or countries that the Food and Drug Administration has cleared of suspicion. Check the Web site www.fda.gov for an updated list. Also safe are grape tomatoes Source: www.newsday.com FDA Hits Merck & Co. with Double Whammy for Gardasil Label Extensions - Genetic Engineering News FDA issued negative reviews of two sBLAs from Merk & Co. related to its HPV vaccine, Gardasil. The agency decided that submitted data did not support approving Gardasil in nonvaccine HPV types. In a separate complete response letter, FDA also found Source: www.genengnews.com FDA Approves New 5 In 1 Vaccine For Children To Reduce Shots - dbtechno.com FDA Approves New 5 In 1 Vaccine For Children To Reduce Shots - dbtechno.com
Boston (dbTechno) - The U.S. Food and Drug Administration has approved a new 5 in 1 vaccine for children which will help by greatly reducing the number of shots children need to go through. As of now, a child in the U.S. needs to receive 23 shots Source: www.dbtechno.com Ranbaxy gets U.S. FDA approval to make, market Valganciclovir HCI - CNBC MUMBAI (Thomson Financial) - India's Ranbaxy Laboratories Ltd. said it received approval from the United States Food and Drug Administration to manufacture and market Valganciclovir HCI tablets, used in the treatment of cytomegalovirus (CMV Source: www.cnbc.com FDA Takes Action against Seafood Processing Company, Executives FDA Takes Action against Seafood Processing Company, Executives
The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act. FDA Announces New Labeling Changes for Regranex The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01 percent (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients. Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names (May 28) Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk. This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. FDA Announces Limited Return of Heartworm Drug to U.S. Market ProHeart 6 Sustained Release Injectable for Dogs, manufactured by Fort Dodge Animal Health, is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return, to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs. FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. Lake Country Lamb Feed Voluntary Recall (June 6) The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper. FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety
In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity. FDA Takes Action against Seafood Processing Company, Executives The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act. FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications. Beware of Bug Bites and Stings Beware of Bug Bites and Stings
Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. Recalls and Safety Alerts: Neupro Patches Recalled Schwarz Pharma recalled Neupro (rotigotine) transdermal patches at the end of April 2008. These patches are used to treat early stage Parkinson's disease. The problem is that rotigotine, the active ingredient, may crystallize in the patch. If th... Patients Are Asking: Getting the Most Out of Blood Glucose Meters Keeping glucose levels under control can help people with diabetes feel better and also lower the risk of blindness, kidney disease, and nerve damage. Very high or very low blood sugar can have serious consequences. Although blood glucose meter... Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12) Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate. Lake Country Lamb Feed Voluntary Recall (June 6) The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of two lamb feed products due to higher than acceptable levels of copper. Contaminated Nipple Cream FDA is warning nursing mothers not to buy or use Mommy's Bliss Nipple Cream because it contains potentially harmful ingredients. Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Warning on Certain Types of Raw Red Tomatoes FDA is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. Ranbaxy gets U.S. FDA approval to make, market Valganciclovir HCI - Forbes Ranbaxy gets U.S. FDA approval to make, market Valganciclovir HCI - Forbes
MUMBAI (Thomson Financial) - India's Ranbaxy Laboratories Ltd. said it received approval from the United States Food and Drug Administration to manufacture and market Valganciclovir HCI tablets, used in the treatment of cytomegalovirus (CMV Source: www.forbes.com US wants to open FDA inspection office in Latin America, find source - International Herald Tribune MEXICO CITY : U.S. Health and Human Services Secretary Michael Leavitt said Monday the United States wants to open an office in Latin America to monitor food safety. His comments came as U.S. inspectors combed Mexican farms and distribution sites to Source: www.iht.com Briefs: Nokia Buys Software Maker; Detroit Newspapers Offering Buyouts - The Ledger Nokia Corp. is buying the consortium that makes the software for its phones and making it available for free to other manufacturers, in hopes of blunting the influence of competing software providers. Nokia said Tuesday that it is offering to buy the Source: www.theledger.com FDA OKs GlaxoSmithKline kids' combination vaccine - MSN MoneyCentral PHILADELPHIA (AP) - GlaxoSmithKline PLC said Wednesday it won Food and Drug Administration approval for a combination vaccine to protect children against diphtheria, tetanus, pertussis and polio. Glaxo said the vaccine, Kinrix, is the first to Source: moneycentral.msn.com FDA Approves Kinrix - New Combination Vaccine for Children - Phramalive.com - New option could mean fewer shots for 4 to 6 year-olds in the U.S. - PHILADELPHIA, June 24, 2008 /PRNewswire-FirstCall/ -- GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has approved KINRIX(TM) [Diphtheria and Source: www.pharmalive.com Quark Pharmaceuticals Receives FDA Approval of IND for Kidney - Biloxi Sun Herald Quark Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application for its siRNA drug candidate, DGFi, in kidney transplantation. The Company expects its Source: www.sunherald.com Water In Tomatoes Can Be A Breeding Ground for Salmonella - Redorbit.com Water In Tomatoes Can Be A Breeding Ground for Salmonella - Redorbit.com
As the Food and Drug Administration investigates a national salmonella outbreak, researchers are finding the farm isn't the only place tomatoes are contaminated. Something as simple as washing a tomato can make it susceptible to both bacteria and Source: www.redorbit.com Ranbaxy gets U.S. FDA approval to make, market Valganciclovir HCI - Forbes MUMBAI (Thomson Financial) - India's Ranbaxy Laboratories Ltd. said it received approval from the United States Food and Drug Administration to manufacture and market Valganciclovir HCI tablets, used in the treatment of cytomegalovirus (CMV Source: www.forbes.com FDA delays decision on Eli Lilly blood clot drug - Forbes Eli Lilly shares hit a new 52-week low Tuesday, a day after the company announced the Food and Drug Administration needed three more months to review its blood thinner drug. The FDA did not ask for new clinical trials, but company spokeswoman Tammy Source: www.forbes.com FDA delays decision on Eli Lilly blood clot drug - NWI.com INDIANAPOLIS - Eli Lilly shares hit a new 52-week low Tuesday, a day after the company announced the Food and Drug Administration needed three more months to review its blood thinner drug. The FDA did not ask for new clinical trials, but company Source: www.thetimesonline.com FDA delays decision on Eli Lilly blood clot drug - NWITimes.com FDA delays decision on Eli Lilly blood clot drug - NWITimes.com
INDIANAPOLIS - Eli Lilly shares hit a new 52-week low Tuesday, a day after the company announced the Food and Drug Administration needed three more months to review its blood thinner drug. The FDA did not ask for new clinical trials, but company Source: nwitimes.com India's Ranbaxy gets FDA nod for Valcyte generic - Reuters MUMBAI, June 25 (Reuters) - India's Ranbaxy Laboratories Ltd (RANB.BO: Quote , Profile , Research , Stock Buzz ) said it had received tentative approval from the U.S. Food and Drug Administration for the generic version of Roche's (ROG.VX: Quote Source: www.reuters.com Microchips may be hazards in hospitals - Philadelphia Inquirer CHICAGO - Wireless systems used by many hospitals to keep track of medical equipment can cause potentially deadly breakdowns in life-saving devices such as breathing and dialysis machines, researchers reported yesterday in a study that warned Source: www.philly.com Ranbaxy gets US FDA nod for Valcyte generic - Livemint.com Mumbai: India’s Ranbaxy Laboratories Ltd has received tentative approval from the US Food and Drug Administration for the generic version of Roche’s anti-viral Valcyte, saying it believed it was the first to file. Ranbaxy said it had tentative Source: www.livemint.com Tomatoes pulled from local shelves, menus - Glendale News-Press GLENDALE — Several local restaurants and grocery stores have cut Roma, plum and red round tomatoes from their food supplies, heeding the Food and Drug Administration’s national warnings that the tomatoes were linked to a salmonella outbreak. The Source: www.glendalenewspress.com FDA delays decision on Eli Lilly blood clot drug prasugrel by 3 months - International Herald Tribune INDIANAPOLIS : Eli Lilly shares hit a new 52-week low Tuesday, a day after the company announced the Food and Drug Administration needed three more months to review its blood thinner drug. The FDA did not ask for new clinical trials, but company Source: www.iht.com GlaxoSmithKline says FDA approves KINRIX combination vaccine for - CNBC PHILADELPHIA (Thomson Financial) - GlaxoSmithKline said the U.S. Food and Drug Administration (FDA) has approved KINRIX, a combination vaccine for children against diphtheria, tetanus, pertussis and polio diseases. Clinical studies of KINRIX have Source: www.cnbc.com After tomato scare, U.S. wants FDA in Latin America - Houston Chronicle After tomato scare, U.S. wants FDA in Latin America - Houston Chronicle
MEXICO CITY — U.S. Health and Human Services Secretary Michael Leavitt said Monday the United States wants to open an office in Latin America to monitor food safety. His comments came as U.S. inspectors combed Mexican farms and distribution sites Source: www.chron.com GlaxoSmithKline says FDA approves KINRIX combination vaccine for - Forbes PHILADELPHIA (Thomson Financial) - GlaxoSmithKline said the U.S. Food and Drug Administration (FDA) has approved KINRIX, a combination vaccine for children against diphtheria, tetanus, pertussis and polio diseases. Clinical studies of KINRIX have Source: www.forbes.com Your Guide to Reporting Problems to FDA Your Guide to Reporting Problems to FDA
This guide provides tips and a quick-reference chart to help you report a problem to FDA. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15) Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN. June 24, 2008Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17) Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17)
Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6) Leiner Health Products Inc. announced that it is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. People who have allergies to fish, tree nuts and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13) ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between June 2006 and May 2008. International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement (May 29) International Pharmaceuticals, Ltd., announced that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving. Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15) Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN. Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7) Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7)
Medtronic, Inc. announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. Abbott Announces Voluntary Worldwide Recall of Two Lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron Powder in 14.1-Ounce (400g) Cans (May 30) Abbott announced a voluntary worldwide recall of two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder in 14.1-ounce cans (400g). Only 14.1-ounce (400g) cans are involved in this action. Calcilo XD is a low-calcium and vitamin D-free infant formula that is specifically designed for the nutrition support of infants and children with hypercalcemia (high calcium in blood). It is only available by special order. Recalls and Safety Alerts: Avoid Using ReadyMED Infusion Pumps with Cubicin In an April 4, 2008 letter, Cubist Pharmaceuticals advised healthcare professionals not to use the drug Cubicin with ReadyMED elastomeric infusion pumps manufactured by Cardinal Health. Cubicin (daptomycin for injection) is an antibiotic used to tre... Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17) Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. Kraft Foods Issues Allergy Alert On Undeclared Tree Nuts In Post LiveActive Mixed Berry Crunch Cereal (June 5) Kraft Foods is recalling 12,553 cases of Post LiveActive Mixed Berry Crunch Cereal with the “Best When Used By” date of 17DEC2008 because a small number of boxes may contain tree nuts (almonds, pecans and/or walnuts), and no nut ingredients are declared on the label. The Post LiveActive Mixed Berry Crunch Cereal has a UPC code of 00430000238900 and comes in a 13-oz retail carton. 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. Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Red Tomato Warning Expanded Nationwide The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these tomatoes. Updated Press Release: Lake Country and LAND O LAKES Lamb Feed Voluntary Recall The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of four lamb feed products, packaged in 50-pound bags, due to the potential for higher than acceptable levels of copper. Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions FDA delays decision on Eli Lilly blood clot drug - WHAS 11 FDA delays decision on Eli Lilly blood clot drug - WHAS 11
Eli Lilly shares hit a new 52-week low Tuesday, a day after the company announced the Food and Drug Administration needed three more months to review its blood thinner drug. The FDA did not ask for new clinical trials, but company spokeswoman Tammy Source: www.whas11.com Invitrogen Advances Drug Discovery Safety Testing - PR Inside www.invitrogen.com - Invitrogen Corporation Media Contact: Revelle Bailey, 760-268-7482 revelle.bailey@invitrogen.com or Customer Contact: predictor@invitrogen.com Invitrogen Corporation (NASDAQ:IVGN), a leading provider of essential life sciences Source: www.pr-inside.com Water In Tomatoes Can Be A Breeding Ground for Salmonella - Redorbit.com As the Food and Drug Administration investigates a national salmonella outbreak, researchers are finding the farm isn't the only place tomatoes are contaminated. Something as simple as washing a tomato can make it susceptible to both bacteria and Source: www.redorbit.com UPDATE: GE Unit Tells FDA Its Heart Imaging Drug Is Safe - CNN Money Silver Spring, Md. -(Dow Jones)- A U.S. Food and Drug Administration panel on Tuesday suggested companies should be required to prove the clinical benefits of ultrasound heart imaging agents before they are approved. The FDA, however, isn't changing Source: money.cnn.com More study of heart imaging agent risks urged - Reuters SILVER SPRING, Maryland (Reuters) - Makers of contrast agents used to enhance echocardiogram images need to conduct larger studies to better evaluate the heart risks seen in some patients, a U.S. panel of medical experts said on Tuesday. The Food and Source: www.reuters.com Sirion Therapeutics Announces FDA Approval of Durezol(TM) for - PR Newswire TAMPA, Fla., June 24 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved its new drug application for Durezol(TM Source: sev.prnewswire.com US to work with Central American growers to ensure food safety - PR Inside SAN SALVADOR, El Salvador (AP) - U.S. Health and Human Services Secretary Michael Leavitt says the United States is partnering with Central American growers to improve the quality of food exports. Leavitt said Tuesday that Washington wants to protect Source: www.pr-inside.com The latest safety tips on eating tomatoes - Newsday Avoid raw red plum, red Roma or red round tomatoes unless they were grown in specific states or countries that the Food and Drug Administration has cleared of suspicion. Check the Web site www.fda.gov for an updated list. Also safe are grape tomatoes Source: www.newsday.com Warner Chilcott gets FDA OK for 150 mg acne drug - Forbes Warner Chilcott Ltd. said Monday the Food and Drug Administration approved a 150 mg strength of Doryx delayed-release tablets as a treatment for severe acne. Doryx Delayed Release is a tetracycline-class oral antibiotic, which contains pellets of Source: www.forbes.com Beware of Online Cancer Fraud Beware of Online Cancer Fraud
FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice. February 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Antipsychotics, Conventional and Atypical New studies show an increased risk of mortality in elderly patients treated for dementia-related psychosis with conventional antipsychotic drugs. Your Guide to Reporting Problems to FDA Your Guide to Reporting Problems to FDA
This guide provides tips and a quick-reference chart to help you report a problem to FDA. Morphine Sulfate 60 mg and 30 mg Extended Release Tablets UPDATE - Additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, were recalled due to the possible presence of oversized tablets. Morphine Sulfate 60 mg Extended Release Tablets Voluntarily recall of a single lot (No. 91762) due to a report of a tablet with twice the appropriate thickness. Drug Shortage: MVI Adult Injectable Hospira information updated. Viril-ity Power (VIP) Tablets Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Regranex (becaplermin) Gel Product given a Boxed Warning about an increased risk of death from cancer in patients using three or more tubes of Regranex. February 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Drug to be Discontinued: Kemadrin (procyclidine hydrochloride) Kemadrin (procyclidine hydrochloride), Dear Healthcare Professional Letter available for more information. Pregnant Women to Benefit from Better Information A proposed rule will give women and their health care professionals better information concerning the effects of medications taken during pregnancy or while breastfeeding. Sirion Therapeutics Announces FDA Approval of Durezol(TM) for - Forbes Sirion Therapeutics Announces FDA Approval of Durezol(TM) for - Forbes
TAMPA, Fla., June 24 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved its new drug application for Durezol(TM Source: www.forbes.com UPDATE 4-Lilly, Daiichi blood-thinning drug faces FDA delay - Reuters TOKYO/LONDON, June 24 (Reuters) - U.S. regulators have extended the review period for Eli Lilly and Co (LLY.N: Quote , Profile , Research , Stock Buzz ) and Daiichi Sankyo's (4568.T: Quote , Profile , Research , Stock Buzz ) new blood-thinning drug Source: www.reuters.com Lilly's Blood-Thinner Prasugrel Delayed by U.S. FDA (Update3) - Bloomberg June 24 (Bloomberg) -- Eli Lilly & Co. and Daiichi Sankyo Co. said U.S. regulators delayed deciding whether to approve their experimental blood-thinning drug prasugrel by three months. The Food and Drug Administration extended the review period of Source: www.bloomberg.com Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension)
Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. U.S. continues investigation into Mexican tomatoes - Xinhua News Agency U.S. continues investigation into Mexican tomatoes - Xinhua News Agency
MEXICO CITY, June 23 (Xinhua) -- The U.S. Food and Drug Administration (FDA) has continued its investigations into Mexican tomatoes to determine if a salmonella outbreak that has sickened more than 500 people in the U.S. originated in Mexico, U.S Source: news.xinhuanet.com Report defends drug companies - San Diego Union-Tribune Answering critics who accuse drug companies of reaping obscene financial reward for little that is innovative, a conservative think tank investigated how the companies turned publicly funded science into therapies for cancer, hypertension and Source: www.signonsandiego.com Genzyme, Isis Cement JV Deal - Street.Com Genzyme GENZ and Isis Pharmaceuticals ISIS said Tuesday that they finalized the license and collaboration agreement for mipomersen, a late-stage cholesterol-lowering antisense drug. In late April, news of regulatory delays for the drug sent shares of Source: www.thestreet.com Sirion Therapeutics Announces FDA Approval of Durezol(TM) for - Forbes TAMPA, Fla., June 24 /PRNewswire/ -- Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved its new drug application for Durezol(TM Source: www.forbes.com The latest safety tips on eating tomatoes - Newsday Avoid raw red plum, red Roma or red round tomatoes unless they were grown in specific states or countries that the Food and Drug Administration has cleared of suspicion. Check the Web site www.fda.gov for an updated list. Also safe are grape tomatoes Source: www.newsday.com After tomato scare, U.S. wants FDA in Latin America - Houston Chronicle MEXICO CITY — U.S. Health and Human Services Secretary Michael Leavitt said Monday the United States wants to open an office in Latin America to monitor food safety. His comments came as U.S. inspectors combed Mexican farms and distribution sites Source: www.chron.com Genzyme and Isis finalize cholesterol drug deal - Boston Globe Genzyme Corp. and Isis Pharmaceuticals Inc. said today that they finalized their agreement to give Genzyme exclusive rights to mipomersen, a cholesterol drug candidate discovered and developed by Isis. Under original terms of the deal, first Source: www.boston.com After tomato scare, U.S. wants FDA in Latin America - Houston Chronicle After tomato scare, U.S. wants FDA in Latin America - Houston Chronicle
MEXICO CITY — U.S. Health and Human Services Secretary Michael Leavitt said Monday the United States wants to open an office in Latin America to monitor food safety. His comments came as U.S. inspectors combed Mexican farms and distribution sites Source: www.chron.com Genzyme completes licensing for cholesterol drug - Boston Globe Genzyme Corp ., a Cambridge company known for orphan drugs, and Isis Pharmaceuticals Inc. today said that they have completed the license and collaboration agreement for the cholesterol drug candidate mipomersen. Announced earlier this year, the Source: www.boston.com CV Therapeutics gets $10M milestone payment - MSN MoneyCentral CV Therapeutics Inc. said Tuesday the commercial launch of Lexiscan triggered a $10 million milestone payment to the company. Palo Alto-based CV (NASDAQ:CVTX) said the drug was launched by Astellas Pharma US Inc. and the payment was made by TPG-Axon Source: news.moneycentral.msn.com FDA calls for seizure of pet food from PETCO Illinois distribution - Detroit News U.S. Marshals have seized animal food products allegedly stored under unsanitary conditions at a PETCO supplies distribution center in Joliet, Ill., U.S. Food and Drug Administration officials said in an alert Monday. Widespread rodent and bird Source: www.detnews.com UPDATE 3-Lilly, Daiichi blood-thinning drug faces FDA delay - Reuters TOKYO/LONDON, June 24 (Reuters) - U.S. regulators have extended the review period for Eli Lilly and Co (LLY.N: Quote , Profile , Research , Stock Buzz ) and Daiichi Sankyo's (4568.T: Quote , Profile , Research , Stock Buzz ) new blood-thinning drug Source: www.reuters.com Genzyme and Isis finalize cholesterol drug deal - Boston Globe Genzyme Corp. and Isis Pharmaceuticals Inc. said today that they finalized their agreement to give Genzyme exclusive rights to mipomersen, a cholesterol drug candidate discovered and developed by Isis. Under original terms of the deal, first Source: www.boston.com CV Therapeutics receives $10M milestone payment - Forbes Biopharmaceutical company CV Therapeutics Inc. said Tuesday it has received a milestone payment of $10 million from TPG-Axon Capital related to the commercial launch of its stress agent Lexiscan. The company said it will record the payment as revenue Source: www.forbes.com FDA delays decision on Eli Lilly blood clot drug - Forbes Eli Lilly and Co. said late Monday the Food and Drug Administration will take an extra three months to review its application for the blood thinning drug prasugrel. Shares fell to a new 52-week low in early Tuesday trading, slipping $1.45, or nearly Source: www.forbes.com After tomato scare, U.S. wants FDA in Latin America - Houston Chronicle After tomato scare, U.S. wants FDA in Latin America - Houston Chronicle
MEXICO CITY — U.S. Health and Human Services Secretary Michael Leavitt said Monday the United States wants to open an office in Latin America to monitor food safety. His comments came as U.S. inspectors combed Mexican farms and distribution sites Source: www.chron.com UPDATE 4-Lilly, Daiichi blood-thinning drug faces FDA delay - Reuters TOKYO/LONDON, June 24 (Reuters) - U.S. regulators have extended the review period for Eli Lilly and Co (LLY.N: Quote , Profile , Research , Stock Buzz ) and Daiichi Sankyo's (4568.T: Quote , Profile , Research , Stock Buzz ) new blood-thinning drug Source: www.reuters.com FDA Approves PrandiMet(TM), a Replaglinide and Metformin Fixed-Dose - MSN MoneyCentral Sciele Pharma, Inc. SCRX and Novo Nordisk Inc. today announced that the U.S. Food and Drug Administration (FDA) approved PrandiMet ™ (repaglinide and metformin HCl) tablets, the first and only fixed-dose combination of the fast-acting secretagogue Source: news.moneycentral.msn.com CV Therapeutics receives $10M milestone payment - MSN MoneyCentral PALO ALTO, Calif. (AP) - Biopharmaceutical company CV Therapeutics Inc. said Tuesday it has received a milestone payment of $10 million from TPG-Axon Capital related to the commercial launch of its stress agent Lexiscan. The company said it will Source: moneycentral.msn.com Novo gets U.S. approval for PrandiMet - Forbes COPENHAGEN June 24 (Reuters) - Denmark's Novo Nordisk said on Tuesday it had received approval from the U.S. Food and Drug Administration for PrandiMet, a fixed-dose combination of an insulin and an insulin sensitiser for type 2 diabetes. The world's Source: www.forbes.com Genzyme completes licensing for cholesterol drug - Boston Globe Genzyme Corp ., a Cambridge company known for orphan drugs, and Isis Pharmaceuticals Inc. today said that they have completed the license and collaboration agreement for the cholesterol drug candidate mipomersen. Announced earlier this year, the Source: www.boston.com Homeopathic means no OK from FDA - Miami Herald Homeopathic means no OK from FDA - Miami Herald
It means that the product, which includes the popular cold remedy Zicam, has not been approved by the Food and Drug Administration. The agency does not routinely review homeopathic medicines in part because their active ingredients have been diluted Source: www.miamiherald.com The latest safety tips on eating tomatoes - Newsday Avoid raw red plum, red Roma or red round tomatoes unless they were grown in specific states or countries that the Food and Drug Administration has cleared of suspicion. Check the Web site www.fda.gov for an updated list. Also safe are grape tomatoes Source: www.newsday.com UPDATE 2-Lilly, Daiichi blood-thinning drug faces FDA delay - Reuters TOKYO/LONDON, June 24 (Reuters) - U.S. regulators have extended the review period for Eli Lilly and Co (LLY.N: Quote , Profile , Research , Stock Buzz ) and Daiichi Sankyo's (4568.T: Quote , Profile , Research , Stock Buzz ) new blood-thinning drug Source: www.reuters.com UPDATE 2-Lilly, Daiichi blood-thinning drug faces FDA delay - Reuters UPDATE 2-Lilly, Daiichi blood-thinning drug faces FDA delay - Reuters
TOKYO/LONDON, June 24 (Reuters) - U.S. regulators have extended the review period for Eli Lilly and Co (LLY.N: Quote , Profile , Research , Stock Buzz ) and Daiichi Sankyo's (4568.T: Quote , Profile , Research , Stock Buzz ) new blood-thinning drug Source: www.reuters.com The latest safety tips on eating tomatoes - Newsday Avoid raw red plum, red Roma or red round tomatoes unless they were grown in specific states or countries that the Food and Drug Administration has cleared of suspicion. Check the Web site www.fda.gov for an updated list. Also safe are grape tomatoes Source: www.newsday.com Homeopathic means no OK from FDA - Miami Herald It means that the product, which includes the popular cold remedy Zicam, has not been approved by the Food and Drug Administration. The agency does not routinely review homeopathic medicines in part because their active ingredients have been diluted Source: www.miamiherald.com UPDATE 1-Daiichi says FDA extends review time for new drug - Reuters UPDATE 1-Daiichi says FDA extends review time for new drug - Reuters
TOKYO, June 24 (Reuters) - Japanese drug maker Daiichi Sankyo (4568.T: Quote , Profile , Research , Stock Buzz ) and Eli Lilly and Co (LLY.N: Quote , Profile , Research , Stock Buzz ) said on Tuesday that U.S. regulators have extended the review Source: www.reuters.com Lilly, Daiichi blood-thinning drug faces FDA delay - Guardian Unlimited TOKYO, June 24 (Reuters) - Japanese drug maker Daiichi Sankyo and Eli Lilly and Co said on Tuesday that U.S. regulators have extended the review period for anti-clotting drug prasugrel, a key experimental medicine for the companies. Daiichi Sankyo Source: www.guardian.co.uk FDA Extends Review Of Daiichi-Lilly Drug Prasugrel For 3 Months - CNN Money Daiichi Sankyo Co. (9130.TO) of Japan and Eli Lilly & Co. (LLY) said the Food and Drug Administration extended the review period three months for their anti- clotting drug prasugrel. The FDA is expected to act by Sept. 26 . Lilly's shares were at $47 Source: money.cnn.com Homeopathic means no OK from FDA - Miami Herald It means that the product, which includes the popular cold remedy Zicam, has not been approved by the Food and Drug Administration. The agency does not routinely review homeopathic medicines in part because their active ingredients have been diluted Source: www.miamiherald.com U.S. continues investigation into Mexican tomatoes - Xinhua News Agency MEXICO CITY, June 23 (Xinhua) -- The U.S. Food and Drug Administration (FDA) has continued its investigations into Mexican tomatoes to determine if a salmonella outbreak that has sickened more than 500 people in the U.S. originated in Mexico, U.S Source: news.xinhuanet.com GPC starts Phase II study on satraplatin cancer drug with prednisone - CNBC MARTINSRIED, Germany (Thomson Financial) - GPC Biotech AG. said it started a Phase II study in the United States, testing its experimental drug satraplatin in combination with the steroid prednisone on prostate cancer patients that could not be Source: www.cnbc.com The latest safety tips on eating tomatoes - Newsday Avoid raw red plum, red Roma or red round tomatoes unless they were grown in specific states or countries that the Food and Drug Administration has cleared of suspicion. Check the Web site www.fda.gov for an updated list. Also safe are grape tomatoes Source: www.newsday.com FDA calls for seizure of pet food from PETCO Illinois distribution - Detroit News U.S. Marshals have seized animal food products allegedly stored under unsanitary conditions at a PETCO supplies distribution center in Joliet, Ill., U.S. Food and Drug Administration officials said in an alert Monday. Widespread rodent and bird Source: www.detnews.com UPDATE 2-Lilly, Daiichi blood-thinning drug faces FDA delay - Reuters TOKYO/LONDON, June 24 (Reuters) - U.S. regulators have extended the review period for Eli Lilly and Co (LLY.N: Quote , Profile , Research , Stock Buzz ) and Daiichi Sankyo's (4568.T: Quote , Profile , Research , Stock Buzz ) new blood-thinning drug Source: www.reuters.com June 23, 2008Warning for Regranex—Cream for Leg and Foot Ulcers Warning for Regranex—Cream for Leg and Foot Ulcers
A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection.
Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again FDA Approves Diaphragm-Pacing Device The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. Recalls and Safety Alerts: Neupro Patches Recalled Schwarz Pharma recalled Neupro (rotigotine) transdermal patches at the end of April 2008. These patches are used to treat early stage Parkinson's disease. The problem is that rotigotine, the active ingredient, may crystallize in the patch. If th... FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications. FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface. Tomato consumer tips - Salon Tomato consumer tips - Salon
—Avoid raw red plum, red Roma or red round tomatoes unless they were grown in specific states or countries that Food and Drug Administration has cleared of suspicion. Check FDA's Web site — http://www.fda.gov — for an updated list. Also safe Source: www.salon.com US FDA licenses Sanofi Pasteur's new pediatric combination vaccine - Genetic Engineering News Swiftwater, PA - Lyon, France - June 23, 2008 - Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has licensed Pentacel®, Diphtheria and Tetanus Toxoids and Acellular Source: www.genengnews.com UPDATE 1-Daiichi says FDA extends review time for new drug - Reuters TOKYO, June 24 (Reuters) - Japanese drug maker Daiichi Sankyo (4568.T: Quote , Profile , Research , Stock Buzz ) and Eli Lilly and Co (LLY.N: Quote , Profile , Research , Stock Buzz ) said on Tuesday that U.S. regulators have extended the review Source: www.reuters.com Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6) Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6)
Leiner Health Products Inc. announced that it is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. People who have allergies to fish, tree nuts and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products. FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these raw, red tomatoes. FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (May 16) The U.S. Food and Drug Administration directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007. Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese (May 15) Sweetwater Valley Farm, Inc. is recalling Tennessee Aged Black Pepper Cheese because it has the potential to be contaminated with Listeria monocytogenes. The cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN. Drug to be Discontinued: Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) Cortisporin Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension), Dear Healthcare Professional Letter available for more information. UPDATE 1-US FDA says medical device reviews became faster - Reuters UPDATE 1-US FDA says medical device reviews became faster - Reuters
WASHINGTON, June 23 (Reuters) - The U.S. Food and Drug Administration has become faster since 2002 at approving applications from makers of medical devices, according to an agency report released on Monday. In fiscal 2006 the agency, on average, took Source: www.reuters.com FDA says medical device reviews became faster - Reuters UK WASHINGTON (Reuters) - The U.S. Food and Drug Administration has become faster since 2002 at approving applications from makers of medical devices, according to an agency report released on Monday. In fiscal 2006 the agency, on average, took 335 days Source: uk.reuters.com Replidyne drops research into antibiotic - MSN MoneyCentral Biotech research company Replidyne Inc. has abandoned research into the experimental antibiotic that was its highest-profile drug candidate after failing to find a financial backer to help get the compound through clinical trials. The Louisville Source: news.moneycentral.msn.com Tomato consumer tips - Salon —Avoid raw red plum, red Roma or red round tomatoes unless they were grown in specific states or countries that Food and Drug Administration has cleared of suspicion. Check FDA's Web site — http://www.fda.gov — for an updated list. Also safe Source: www.salon.com UPDATE 1-GTC Biotherapeutics in a $257 mln deal with Ovation - Reuters June 23 (Reuters) - Drug company GTC Biotherapeutics Inc (GTCB.O: Quote , Profile , Research , Stock Buzz ) said it was in a deal to develop and market, ATryn, its product to treat abnormal blood clotting, with Ovation Pharmaceuticals Inc, sending Source: www.reuters.com Houston lawyer given probation in fake Botox scheme - Houston Chronicle A Houston lawyer received probation Monday in a phony Botox scheme for which his wife, a physician, was sentenced to federal prison. Saul Gower, the former office manager of the Galleria-area Center for Image Enhancement, pleaded guilty last year to Source: www.chron.com FDA Extends Review Period for Daiichi Sankyo, Lilly Investigative - MSN MoneyCentral Companies confirm the start of TRILOGY ACS clinical trial to study Prasugrel against Clopidogrel in medically managed ACS patients TOKYO and INDIANAPOLIS, June 23 /PRNewswire-FirstCall/ -- Daiichi Sankyo Company, Limited, 4568 and Eli Lilly and Source: news.moneycentral.msn.com Glenmark gets USFDA nod for generic anti-hypertension drug - International Business Times Glenmark Generics Ltd, a unit of India's Glenmark Pharmaceuticals Ltd, has received the nod from the US Food and Drug Administration (USFDA) for the sale of its generic version of anti-hypertension drug, Trandolapril. A webshot of corporate homepage Source: in.ibtimes.com US wants to open FDA inspection office in Latin America, find source - International Herald Tribune MEXICO CITY : U.S. Health and Human Services Secretary Michael Leavitt said Monday the United States wants to open an office in Latin America to monitor food safety. His comments came as U.S. inspectors combed Mexican farms and distribution sites to Source: www.iht.com New FDA office - MSNBC MEXICO CITY - U.S. Health and Human Services Secretary Michael Leavitt said Monday the United States wants to open an office in Latin America to monitor food safety. His comments came as U.S. inspectors combed Mexican farms and distribution sites to Source: www.msnbc.msn.com Glenmark gets USFDA nod for generic anti-hypertension drug - International Business Times Glenmark gets USFDA nod for generic anti-hypertension drug - International Business Times
Glenmark Generics Ltd, a unit of India's Glenmark Pharmaceuticals Ltd, has received the nod from the US Food and Drug Administration (USFDA) for the sale of its generic version of anti-hypertension drug, Trandolapril. A webshot of corporate homepage Source: in.ibtimes.com FDA extends review of GlaxoSmithKline treatment - MSN MoneyCentral FDA extends review of GlaxoSmithKline treatment - MSN MoneyCentral
The U.S. Food and Drug Administration will take an extra three months to review a drug co-developed by GlaxoSmithKline, GSK says. U.S. regulators were set to decide by June 19 whether the drug, Promacta, could hit the markets. But the FDA needs more Source: news.moneycentral.msn.com Houston lawyer given probation in fake Botox scheme - Houston Chronicle A Houston lawyer received probation Monday in a phony Botox scheme for which his wife, a physician, was sentenced to federal prison. Saul Gower, the former office manager of the Galleria-area Center for Image Enhancement, pleaded guilty last year to Source: www.chron.com Warner Chilcott gets FDA OK for 150 mg acne drug - CNN Money NEW YORK (Associated Press) - Warner Chilcott Ltd. said Monday the Food and Drug Administration approved a 150 mg strength of Doryx delayed-release tablets as a treatment for severe acne. Doryx Delayed Release is a tetracycline-class oral antibiotic Source: money.cnn.com UPDATE 1-GTC Biotherapeutics in a $257 mln deal with Ovation - Reuters June 23 (Reuters) - Drug company GTC Biotherapeutics Inc (GTCB.O: Quote , Profile , Research , Stock Buzz ) said it was in a deal to develop and market, ATryn, its product to treat abnormal blood clotting, with Ovation Pharmaceuticals Inc, sending Source: www.reuters.com US wants to open FDA inspection office in Latin America, find source - International Herald Tribune MEXICO CITY : U.S. Health and Human Services Secretary Michael Leavitt said Monday the United States wants to open an office in Latin America to monitor food safety. His comments came as U.S. inspectors combed Mexican farms and distribution sites to Source: www.iht.com US consumers face advent of cloned food - Financial Times Duane Kraemer approaches with pride the Angus bull eating hay behind a fence at Texas A&M University. As the veterinary surgeon draws near, the bull snorts and paws the ground. Healthy as he looks, many Americans would not want to see this bull Source: www.ft.com Tomato consumer tips - Salon —Avoid raw red plum, red Roma or red round tomatoes unless they were grown in specific states or countries that Food and Drug Administration has cleared of suspicion. Check FDA's Web site — http://www.fda.gov — for an updated list. Also safe Source: www.salon.com UPDATE 1-US FDA says medical device reviews became faster - Reuters WASHINGTON, June 23 (Reuters) - The U.S. Food and Drug Administration has become faster since 2002 at approving applications from makers of medical devices, according to an agency report released on Monday. In fiscal 2006 the agency, on average, took Source: www.reuters.com FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (May 16) FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled (May 16)
The U.S. Food and Drug Administration directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007. FDA Takes Action against Seafood Processing Company, Executives The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act. Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12) Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate. Viril-ity Power (VIP) Tablets Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Regranex (becaplermin) Gel Product given a Boxed Warning about an increased risk of death from cancer in patients using three or more tubes of Regranex. FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles. FDA Announces New Labeling Changes for Regranex The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01 percent (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients. Calcilo XD Low-Calcium Vitamin D-Free Infant Formula With Iron Powder Product recalled because of possible oxidation that can cause gastrointestinal symptoms in infants. Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release) HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA. Warning for Regranex—Cream for Leg and Foot Ulcers Warning for Regranex—Cream for Leg and Foot Ulcers
A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. Morphine Sulfate 60 mg and 30 mg Extended Release Tablets UPDATE - Additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, were recalled due to the possible presence of oversized tablets. Patients Are Asking: Getting the Most Out of Blood Glucose Meters Keeping glucose levels under control can help people with diabetes feel better and also lower the risk of blindness, kidney disease, and nerve damage. Very high or very low blood sugar can have serious consequences. Although blood glucose meter... Heartworm Prevention in Your Pet A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program. Enforcement Actions for Food Safety Violations In separate enforcement actions, FDA shuts down companies for food safety violations. These actions include a recall of certain smoked seafood products. FDA Takes Action Against Scientific Laboratories Inc. A permanent injunction bars Scientific Laboratories from making and distributing drug products until its manufacturing operations comply with law and its products are approved. Recalls and Safety Alerts: FDA Studying Potential Safety Issues with Several Drugs FDA has informed the health care community about ongoing safety reviews of several drugs. FDA is doing this as part of its commitment to inform health care professionals and the public about its ongoing drug safety reviews. Because this information... Controlling Cholesterol with Statins When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe statin medications. These drugs can reduce the risk of heart attack, stroke, and death. Spring 2008 Drug Safety Newsletter DSN provides information for healthcare professionals and the medical community about findings of selected post-marketing drug safety reviews, important emerging drug safety issues, and recently approved new molecular entities. FDA Takes Action against Seafood Processing Company, Executives FDA Takes Action against Seafood Processing Company, Executives
The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act. UPDATE 1-Warner Chilcott gets FDA nod for Doryx 150mg tablets - Reuters UPDATE 1-Warner Chilcott gets FDA nod for Doryx 150mg tablets - Reuters
June 23 (Reuters) - Warner Chilcott Ltd (WCRX.O: Quote , Profile , Research , Stock Buzz ) said it received approval from the U.S. Food and Drug Administration for the 150mg dosage of its Doryx Delayed-Release tablets used for treating severe acne Source: www.reuters.com FDA Lifts Clinical Hold on Genta's Tesetaxel, a Leading Oral Taxane - MSN MoneyCentral BERKELEY HEIGHTS, N.J., June 23 /PRNewswire-FirstCall/ -- Genta Incorporated (OTC Bulletin Board: GNTA) announced that the Company has received notification from the U.S. Food and Drug Administration (FDA) that Genta may resume clinical trials with Source: news.moneycentral.msn.com FDA tomato traceback leads to Florida, Mexico - Pizza Marketplace North Florida NewsDaily.com: Federal health authorities have announced that investigators looking for the source of a salmonella outbreak linked to tomatoes will focus on farms and their supply chains in Mexico and Florida. Since April, 552 people in Source: www.pizzamarketplace.com New England Research Institutes, Inc., Assists Medtronic, Inc., in - Forbes New England Research Institutes, Inc. (NERI), a global, privately held specialty Contract Research Organization (CRO), today announced that their statistical analysis of data in The Lifeline Registry of Endovascular Aneurysm Repair (EVAR) contributed Source: www.forbes.com U.S. FDA seeks India post for food, drug checks - Reuters India U.S. FDA seeks India post for food, drug checks - Reuters India
WASHINGTON (Reuters) - The U.S. Food and Drug Administration hopes to establish operations in India by year's end to better police the growing volume of food, medicines, medical devices and animal feed exported to the United States, a top official Source: in.reuters.com Ahead of the Bell: Acorda Therapeutics downgraded - CNBC NEW YORK - A Friedman Billings Ramsey analyst thinks shares of Acorda Therapeutics will stay around their current prices until early next year, when the company asks regulators to approve its multiple sclerosis drug Fampridine-SR. David Amsellem Source: www.cnbc.com FDA follows new clues to salmonella - Philadelphia Inquirer WASHINGTON - Food and Drug Administration inspectors headed for farms in Florida and Mexico yesterday, as new clues emerged to the possible source of salmonella-tainted tomatoes that have sickened 552 people, a large jump from previous estimates. The Source: www.philly.com Sanofi-Aventis receives U.S. FDA licence for Pentacel vaccine - CNBC PARIS (Thomson Financial) - Sanofi Pasteur, the vaccines division of Sanofi-Aventis, said the U.S. Food and Drug Administration has licensed Pentacel, the company's five-in-one pediatric vaccine against diphtheria, tetanus, pertussis, polio and Source: www.cnbc.com Warner Chilcott gets FDA OK for 150 mg acne drug - Forbes Warner Chilcott Ltd. said Monday the Food and Drug Administration approved a 150 mg strength of Doryx delayed-release tablets as a treatment for severe acne. Doryx Delayed Release is a tetracycline-class oral antibiotic, which contains pellets of Source: www.forbes.com UPDATE 1-GTC Biotherapeutics in a $257 mln deal with Ovation - Reuters June 23 (Reuters) - Drug company GTC Biotherapeutics Inc (GTCB.O: Quote , Profile , Research , Stock Buzz ) said it was in a deal to develop and market, ATryn, its product to treat abnormal blood clotting, with Ovation Pharmaceuticals Inc, sending Source: www.reuters.com Warner Chilcott Announces Approval of DORYX Delayed-Release 150 mg - MSN MoneyCentral ST. DAVID'S, Bermuda, June 23, 2008 (PRIME NEWSWIRE) -- Warner Chilcott Limited (Nasdaq:WCRX) announced today that the Food and Drug Administration (FDA) has approved a 150 mg strength of DORYX(r) (doxycycline hyclate) Delayed-Release Tablets. DORYX Source: news.moneycentral.msn.com FDA Lifts Clinical Hold on Genta's Tesetaxel, a Leading Oral Taxane - Forbes BERKELEY HEIGHTS, N.J., June 23 /PRNewswire-FirstCall/ -- Genta Incorporated (OTC Bulletin Board: GNTA) announced that the Company has received notification from the U.S. Food and Drug Administration (FDA) that Genta may resume clinical trials with Source: www.forbes.com UCLA Seeks Patients 8-to-17 with Friedreich’s Ataxia (FRDA) for New - Jewish Journal of Greater Los Angeles Programs UCLA Seeks Patients 8-to-17 with Friedreich’s Ataxia (FRDA) for New Drug Study FRDA is an inherited disease that causes progressive damage to the nervous system. Source: www.jewishjournal.com Phase Forward and AG Mednet Form Alliance to Develop Integrated - MSN MoneyCentral Phase Forward PFWD , a leading provider of data management solutions for clinical trials and drug safety, today announced it has formed an alliance with AG Mednet, a clinical trials imaging network, to integrate Phase Forward ’ s InForm Source: news.moneycentral.msn.com FDA Requests Seizure of Animal Food Products at PETCO Distribution Center FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release) U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People�s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety. FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release) HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA. Pregnant Women to Benefit from Better Information A proposed rule will give women and their health care professionals better information concerning the effects of medications taken during pregnancy or while breastfeeding. June 2008 Patient Safety News June 2008 Patient Safety News
Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Xiadafil VIP Tablets Consumers advised not to purchase or use the product, marketed as a dietary supplement, because it contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Morphine Sulfate 60 mg and 30 mg Extended Release Tablets UPDATE - Additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, were recalled due to the possible presence of oversized tablets. Sentinel System to Monitor Medical Product Safety FDA's new Sentinel Initiative aims to establish a national electronic system for tracking medical product performance. Heartworm Prevention in Your Pet A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program. Warning on Certain Types of Raw Red Tomatoes FDA is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. FDA heads for Florida, Mexico farms in tomato probe - MSNBC FDA heads for Florida, Mexico farms in tomato probe - MSNBC
NEW YORK - Food and Drug Administration inspectors are heading for farms in Florida and Mexico, as new clues emerge to the possible source of salmonella-tainted tomatoes that have now sickened 552 people. The FDA wouldn’t say where in Florida and Source: www.msnbc.msn.com Tomatoes pulled from local shelves, menus - Glendale News-Press GLENDALE — Several local restaurants and grocery stores have cut Roma, plum and red round tomatoes from their food supplies, heeding the Food and Drug Administration’s national warnings that the tomatoes were linked to a salmonella outbreak. The Source: www.glendalenewspress.com FDA warns 2 Fla. firms - Miami Herald In a federal crackdown on what it called ''online cancer fraud,'' the Food and Drug Administration has released the names of suspected violators who have received warning letters, including two in Florida. The letters warned the recipients about Source: www.miamiherald.com FDA says deaths with heart imaging drugs continue - Boston Globe WASHINGTON— Despite previous warnings to physicians, drugs used to improve medical images of the heart continue to be linked to serious side effects and some deaths, regulators said Friday. The Food and Drug Administration said that since October Source: www.boston.com FDA inspectors to Fla., Mexico in salmonella probe - NWI.com WASHINGTON - There may be a break in the salmonella case: Food and Drug Administration inspectors headed for farms in Florida and Mexico on Friday, as new clues emerge to the possible source of salmonella-tainted tomatoes that have now sickened 552 Source: www.thetimesonline.com Paris shares TFN at a glance outlook - CNBC PARIS (Thomson Financial) - Shares are expected to open flat as investors seek fresh direction following Friday's sell-off on both sides of the Atlantic. On Friday, the CAC-40 index finished down 82.12 points or 1.79 percent at 4,509.27. On the Matif Source: www.cnbc.com June 22, 2008Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP) Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP)
Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP. Dear Healthcare Professional Letter is available for more information. FDA heads for Florida, Mexico farms in tomato probe - MSNBC FDA heads for Florida, Mexico farms in tomato probe - MSNBC
NEW YORK - Food and Drug Administration inspectors are heading for farms in Florida and Mexico, as new clues emerge to the possible source of salmonella-tainted tomatoes that have now sickened 552 people. The FDA wouldn’t say where in Florida and Source: www.msnbc.msn.com Ligand Partner GlaxoSmithKline Receives FDA Extended Priority Review - MSN MoneyCentral Ligand Pharmaceuticals Incorporated LGND announced today that the U.S. Food and Drug Administration has extended the priority review period for GlaxoSmithKline ’ s (GSK) New Drug Application (NDA) for PROMACTA ® (eltrombopag) for the short-term Source: news.moneycentral.msn.com Bayer Removes Remaining Trasylol Stock Bayer Removes Remaining Trasylol Stock
Bayer will begin removing the remaining Trasylol, a drug used to control bleeding during heart surgery, from the U.S. market. FDA Announces Limited Return of Heartworm Drug to U.S. Market ProHeart 6 Sustained Release Injectable for Dogs, manufactured by Fort Dodge Animal Health, is an approved injectable sustained-release heartworm prevention product for dogs. FDA is concurring with its limited return, to the U.S. veterinary market under a risk minimization and restricted distribution program designed to manage the re-introduction of ProHeart 6 to provide for safe, appropriate use of the product while minimizing risk to dogs. Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17) Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27) As a precautionary measure, Supreme Cuts LLC has announced that it is voluntarily recalling 87 cases of Off the Cob Fresh Kernel Corn in 12 oz bags. The product may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people, and others with weakened immune systems. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release) HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA. Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6) Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6)
Leiner Health Products Inc. announced that it is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. People who have allergies to fish, tree nuts and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products. Morphine Sulfate 60 mg and 30 mg Extended Release Tablets UPDATE - Additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, were recalled due to the possible presence of oversized tablets. Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12) Atrium Medical Corporation today announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate. Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7) Medtronic, Inc. announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27) As a precautionary measure, Supreme Cuts LLC has announced that it is voluntarily recalling 87 cases of Off the Cob Fresh Kernel Corn in 12 oz bags. The product may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people, and others with weakened immune systems. Abbott Announces Voluntary Worldwide Recall of Two Lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron Powder in 14.1-Ounce (400g) Cans (May 30) Abbott Announces Voluntary Worldwide Recall of Two Lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron Powder in 14.1-Ounce (400g) Cans (May 30)
Abbott announced a voluntary worldwide recall of two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder in 14.1-ounce cans (400g). Only 14.1-ounce (400g) cans are involved in this action. Calcilo XD is a low-calcium and vitamin D-free infant formula that is specifically designed for the nutrition support of infants and children with hypercalcemia (high calcium in blood). It is only available by special order. Leiner Health Products Issues Allergy Alert on Undeclared Allergens in Liquimax Multivitamin (June 6) Leiner Health Products Inc. announced that it is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. People who have allergies to fish, tree nuts and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products. Calcilo XD Low-Calcium Vitamin D-Free Infant Formula With Iron Powder Product recalled because of possible oxidation that can cause gastrointestinal symptoms in infants. Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) FDA investigating TNF blockers and cancer risk in children and young adults. US FDA seeks India post for food, drug checks - newindpress US FDA seeks India post for food, drug checks - newindpress
WASHINGTON: The US Food and Drug Administration hopes to establish operations in India by year's end to better police the growing volume of food, medicines, medical devices and animal feed exported to the United States, a top official told Reuters on Source: www.newindpress.com |
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