June 7, 2008Drug 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. 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. 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 Approves Entereg to Help Restore Bowel Function Following Surgery The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses. Important Information about Albuterol Metered Dose Inhalers (MDIs) After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information) 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. New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2) Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2)
Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash. Fresca Italia, Inc., Recalls Burrata Because of Possible Health Risk (May 30) Fresca Italia of Brisbane, CA is recalling Burrata 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 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 Safety Update: Asthma Medications May is Asthma and Allergy Awareness Month. Here is a roundup of recent safety issues related to asthma medications. FDA Approves Entereg to Help Restore Bowel Function Following Surgery The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses. FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products. FDA Takes Action against Cream Cheese Companies, Executives The U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, until they are found compliant with food-safety laws. 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. FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A 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. Bristol-Myers, AstraZeneca Diabetes Drug Effective In Study - CNN Money Bristol-Myers, AstraZeneca Diabetes Drug Effective In Study - CNN Money
NEW YORK -(Dow Jones)- A late-stage study of saxagliptin, developed by Bristol-Myers Squibb Co. (BMY) and AstraZeneca (AZN), shows the drug is effective in treating type 2 diabetes with a safety profile similar to placebo. The companies also proposed Source: money.cnn.com Fidelity's top lawyer resigns to be full-time law teacher - Boston Globe FDA adds cancer warning to J&J foot ulcer medicine The Food and Drug Administration warned patients that using large amounts of a Johnson & Johnson foot ulcer medication could heighten their risk of dying from cancer. The FDA added its most serious Source: www.boston.com ADA Comments on FDA's Settlement of Dental Amalgam Lawsuit - Biloxi Sun Herald The American Dental Association (ADA) believes the recent settlement between the U.S. Food and Drug Administration (FDA) and the group Moms Against Mercury simply sets a definite deadline (July 28, 2009) for the FDA to complete what it began in 2002 Source: www.sunherald.com Bristol, Takeda Drugs Offer Alternatives to Januvia (Correct) - Bloomberg June 7 (Bloomberg) -- Bristol-Myers Squibb Co ., AstraZeneca Plc and Takeda Pharmaceuticals Co. 's experimental diabetes drugs may give U.S. patients effective alternatives to Merck & Co.'s Januvia, one of the newest pills approved for the condition Source: www.bloomberg.com Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27) 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. June 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. 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. Novartis' bone-building drug gets new FDA approval - Forbes Novartis' bone-building drug gets new FDA approval - Forbes
Drug developer Novartis AG said Thursday the Food and Drug Administration approved the bone-building drug Reclast as a treatment to prevent additional fractures following a hip fracture. The once-yearly drug is already approved in the U.S. and Europe Source: www.forbes.com UPDATE: FDA To Restrict Wyeth Heartworm Drug Distribution - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration on Thursday said it will allow a limited return to the market of Wyeth's (WYE) controversial anti-heartworm drug for dogs. Wyeth's unit, Fort Dodge Animal Health, voluntarily pulled the Source: money.cnn.com UCB granted pediatric exclusivity for epilepsy drug Keppra by U.S. FDA - Forbes BRUSSELS (Thomson Financial) - Belgian pharmaceutical company UCB announced Friday that the U.S. Food and Drug Administration (FDA) has granted it pediatric exclusivity for the epilepsy treatment Keppra. The decision was based on pediatric data Source: www.forbes.com Group petitions FDA to ban some food colorings - Los Angeles Times WASHINGTON -- A consumer advocacy group called on the Food and Drug Administration Tuesday to ban the use of eight artificial colorings in food because the additives may cause hyperactivity and behavior problems in some children. Controlled studies Source: www.latimes.com Fidelity's top lawyer resigns to be full-time law teacher - Boston Globe FDA adds cancer warning to J&J foot ulcer medicine The Food and Drug Administration warned patients that using large amounts of a Johnson & Johnson foot ulcer medication could heighten their risk of dying from cancer. The FDA added its most serious Source: www.boston.com Fidelity's top lawyer resigns to be full-time law teacher - Boston Globe Fidelity's top lawyer resigns to be full-time law teacher - Boston Globe
FDA adds cancer warning to J&J foot ulcer medicine The Food and Drug Administration warned patients that using large amounts of a Johnson & Johnson foot ulcer medication could heighten their risk of dying from cancer. The FDA added its most serious Source: www.boston.com FDA eyes stricter rules for contact lens solutions - Boston Globe WASHINGTON— Federal regulators are considering stricter testing requirements for contact lens solutions after two popular formulas were linked to hundreds of eye infections in the past two years. The Food and Drug Administration outlined several Source: www.boston.com Abbott drugs in FDA risk reviews - Chicago Tribune The Food and Drug Administration is taking a look at serious health risks in certain patients taking drugs in the same class as two of Abbott Laboratories ' top-selling prescription medications. On Wednesday, the FDA said it will conduct a safety Source: www.chicagotribune.com US FDA Admits Risks of Mercury Dental Fillings, Settles Lawsuit - Forbes WASHINGTON, June 5 /PRNewswire-USNewswire/ -- "After 32 years of delay, the Food and Drug Administration has finally agreed to comply with the law and set a date to classify mercury amalgam as a substance that poses a health risk to pregnant women Source: www.forbes.com FDA Shifts, Says Mercury Dental Fillings May Harm Some - The Ledger PHILADELPHIA | After years of asserting that mercury in fillings was safe, the Food and Drug Administration now says it may be harmful to pregnant women, children, fetuses, and people who are especially sensitive to mercury exposure. "Dental amalgams Source: www.theledger.com UPDATE: FDA To Restrict Wyeth Heartworm Drug Distribution - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration on Thursday said it will allow a limited return to the market of Wyeth's (WYE) controversial anti-heartworm drug for dogs. Wyeth's unit, Fort Dodge Animal Health, voluntarily pulled the Source: money.cnn.com Supreme Cuts Announces Voluntary Recall of Small Sample of Off The Cob Fresh Kernel Corn (May 27) 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. Start at the Store: 7 Ways to Prevent Foodborne Illness Food safety for consumers should begin at the supermarket or grocery store. Here are useful hints to keep in mind when shopping for food that will help keep foodborne illnesses out of your home. 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 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. 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. Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007. 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. 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. 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. Contaminated Nipple Cream FDA is warning nursing mothers not to buy or use Mommy's Bliss Nipple Cream because it contains potentially harmful ingredients. US FDA Admits Risks of Mercury Dental Fillings, Settles Lawsuit - Forbes US FDA Admits Risks of Mercury Dental Fillings, Settles Lawsuit - Forbes
WASHINGTON, June 5 /PRNewswire-USNewswire/ -- "After 32 years of delay, the Food and Drug Administration has finally agreed to comply with the law and set a date to classify mercury amalgam as a substance that poses a health risk to pregnant women Source: www.forbes.com FDA eyes stricter rules for contact lens solutions - Boston Globe WASHINGTON— Federal regulators are considering stricter testing requirements for contact lens solutions after two popular formulas were linked to hundreds of eye infections in the past two years. The Food and Drug Administration outlined several Source: www.boston.com Tomato salmonella scare stirs FDA's critics - Houston Chronicle As Texas and the nation grapple with a major outbreak of potentially deadly salmonella poisoning from tomatoes, critics of the U.S. Food and Drug Administration are blasting the agency for sluggishness in ensuring the safety of America's food supply Source: www.chron.com Chantix (varenicline) Chantix (varenicline)
UPDATE - Prescribing information revised to include safety information regarding serious neuropsychiatric symptoms in the WARNINGS and PRECAUTIONS sections of the label. Additionally, a Medication Guide for patients is available. Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007. 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. Sentinel System to Monitor Medical Product Safety Sentinel System to Monitor Medical Product Safety
FDA's new Sentinel Initiative aims to establish a national electronic system for tracking medical product performance. Contaminated Nipple Cream FDA is warning nursing mothers not to buy or use Mommy's Bliss Nipple Cream because it contains potentially harmful ingredients. 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. 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. 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... Drug Approved for Irritable Bowel Syndrome with Constipation FDA has approved Amitza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over 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... June 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. FDA: Minneapolis seafood company has violated safety laws - Minneapolis Star Tribune FDA: Minneapolis seafood company has violated safety laws - Minneapolis Star Tribune
MINNEAPOLIS - The federal Food and Drug Administration says a Minneapolis seafood processor has violated food safety laws. The FDA says Captain's Select Seafood Inc. has an extensive history of violating the Federal Food, Drug and Cosmetic Act and Source: www.startribune.com FDA To Restrict Wyeth Heartworm Drug Distribution - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration said Thursday it will allow a limited return to the market of Wyeth's (WYE) heartworm drug for dogs. Wyeth's unit, Fort Dodge Animal Health, voluntarily pulled the drug, Proheart 6, from Source: money.cnn.com Novartis' bone-building drug gets new FDA approval - Forbes Drug developer Novartis AG said Thursday the Food and Drug Administration approved the bone-building drug Reclast as a treatment to prevent additional fractures following a hip fracture. The once-yearly drug is already approved in the U.S. and Europe Source: www.forbes.com FDA Brain Drain Harms Drug Approvals, Food Inspections - FOX News When pharmaceutical consulting firm Quintiles wants to hire a new employee, the first place it looks is the Food and Drug Administration. These former insiders bring critical expertise to the consultant and clients like Merck & Co. Inc. and Pfizer Source: www.foxnews.com FDA cites possible risks with mercury in fillings - Arizona Daily Star PHILADELPHIA — After years of asserting that mercury in fillings was safe, the Food and Drug Administration now says it may be harmful to pregnant women, children, fetuses, and people who are especially sensitive to mercury exposure. "Dental Source: www.azstarnet.com FDA adds cancer warnings to J&J foot ulcer cream - Los Angeles Times WASHINGTON -- The Food and Drug Administration warned patients Friday that using large amounts of a Johnson & Johnson foot ulcer medication could heighten their risk of dying from cancer. The FDA added its most serious warning to the company's cream Source: www.latimes.com FDA eyes stricter contact lens solution rules - Los Angeles Times WASHINGTON -- Federal regulators are considering stricter testing requirements for contact lens solutions after two popular formulas were linked to hundreds of eye infections in the last two years. The Food and Drug Administration outlined several Source: www.latimes.com FDA reviewing arthritis drugs for kids' cancer link - MSNBC WASHINGTON - Federal regulators are investigating whether a group of best-selling arthritis drugs made by Abbott Laboratories, Schering-Plough Corp. and other companies heighten the risk of cancer in youngsters. The Food and Drug Administration said Source: www.msnbc.msn.com UPDATE: FDA To Restrict Wyeth Heartworm Drug Distribution - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration on Thursday said it will allow a limited return to the market of Wyeth's (WYE) controversial anti-heartworm drug for dogs. Wyeth's unit, Fort Dodge Animal Health, voluntarily pulled the Source: money.cnn.com June 6, 2008Pregnant Women to Benefit from Better 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. Mommy's Bliss Nipple Cream Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). 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. Chantix (varenicline) UPDATE - Prescribing information revised to include safety information regarding serious neuropsychiatric symptoms in the WARNINGS and PRECAUTIONS sections of the label. Additionally, a Medication Guide for patients is available. In shift, FDA says amalgam dental fillings may harm some - Dallas Morning News In shift, FDA says amalgam dental fillings may harm some - Dallas Morning News
PHILADELPHIA – After years of asserting that mercury in fillings was safe, the Food and Drug Administration now says it may be harmful to pregnant women, children, fetuses, and people who are especially sensitive to mercury exposure. "Dental Source: www.dallasnews.com FDA, Facing Criticism, Bars Doctors From Drug Trials (Update1) - Bloomberg June 6 (Bloomberg) -- U.S. regulators have barred seven doctors from conducting clinical trials of drugs and medical devices so far this year, as many as in the three previous years combined, after lawmakers complained about delays in discipline. The Source: www.bloomberg.com FDA adds cancer warnings to J&J foot ulcer cream - San Francisco Gate The Food and Drug Administration warned patients Friday that using large amounts of a Johnson & Johnson foot ulcer medication could heighten their risk of dying from cancer. The FDA added its most serious warning to the company's cream medication Source: www.sfgate.com FDA adds cancer warnings to J&J foot ulcer cream - Los Angeles Times WASHINGTON -- The Food and Drug Administration warned patients Friday that using large amounts of a Johnson & Johnson foot ulcer medication could heighten their risk of dying from cancer. The FDA added its most serious warning to the company's cream Source: www.latimes.com FDA eyes stricter rules for contact lens solutions - Boston Globe WASHINGTON— Federal regulators are considering stricter testing requirements for contact lens solutions after two popular formulas were linked to hundreds of eye infections in the past two years. The Food and Drug Administration outlined several Source: www.boston.com Tomatoes in Salmonella outbreak not grown in Texas - Houston Chronicle AUSTIN — Tomatoes linked to a Salmonella outbreak in Texas and New Mexico were not grown in Texas, state and federal officials said Friday. Texas state agriculture officials said Texas was one of 12 states or countries eliminated by the federal Source: www.chron.com FDA reviewing arthritis drugs for kids' cancer link - MSNBC WASHINGTON - Federal regulators are investigating whether a group of best-selling arthritis drugs made by Abbott Laboratories, Schering-Plough Corp. and other companies heighten the risk of cancer in youngsters. The Food and Drug Administration said Source: www.msnbc.msn.com UCB granted pediatric exclusivity for epilepsy drug Keppra by U.S. FDA - Forbes UCB granted pediatric exclusivity for epilepsy drug Keppra by U.S. FDA - Forbes
BRUSSELS (Thomson Financial) - Belgian pharmaceutical company UCB announced Friday that the U.S. Food and Drug Administration (FDA) has granted it pediatric exclusivity for the epilepsy treatment Keppra. The decision was based on pediatric data Source: www.forbes.com Amgen, Wyeth Pharma support FDA review of tumor necrosis factor - Forbes SAN FRANCISCO (Thomson Financial) - Amgen Inc. and Wyeth unit Wyeth Pharmaceuticals responded Wednesday to a Food and Drug Administration report about the agency's ongoing safety review of several tumor necrosis factor blocker drugs, saying they Source: www.forbes.com Tomatoes in Salmonella outbreak not grown in Texas - Houston Chronicle AUSTIN — Tomatoes linked to a Salmonella outbreak in Texas and New Mexico were not grown in Texas, state and federal officials said Friday. Texas state agriculture officials said Texas was one of 12 states or countries eliminated by the federal Source: www.chron.com U.S. regulator seeks stricter rules for contact lens solutions - International Herald Tribune WASHINGTON : U.S. regulators are considering stricter testing requirements for contact lens solutions after two popular formulas were linked to hundreds of eye infections in the past two years. The Food and Drug Administration outlined several Source: www.iht.com In shift, FDA says amalgam dental fillings may harm some - Dallas Morning News PHILADELPHIA – After years of asserting that mercury in fillings was safe, the Food and Drug Administration now says it may be harmful to pregnant women, children, fetuses, and people who are especially sensitive to mercury exposure. "Dental Source: www.dallasnews.com Amylin shares tumble on rival drug trial results - MSN MoneyCentral NEW YORK (AP) - Danish drug developer Novo Nordisk said Friday its late-stage type 2 diabetes drug liraglutide controlled blood sugar better than a rival drug from Amylin Pharmaceuticals Inc., sending Amylin shares down. In afternoon trading, Amylin Source: news.moneycentral.msn.com In shift, FDA says mercury fillings may harm some - Philadelphia Inquirer After years of asserting that mercury in fillings was safe, the Food and Drug Administration now says it may be harmful to pregnant women, children, fetuses, and people who are especially sensitive to mercury exposure. "Dental amalgams contain Source: www.philly.com FDA panel favors Glaxo, Ligand blood drug - Associated Press WASHINGTON (AP) -- Advisers to the Food and Drug Administration said Friday a blood-clotting drug from GlaxoSmithKline PLC and Ligand Pharmaceuticals Inc. is effective for short-term use, despite reservations by FDA scientists. A panel of 16 outside Source: hosted.ap.org FDA adds cancer warnings to J&J foot ulcer cream - CNBC WASHINGTON (AP) - The Food and Drug Administration warned patients Friday that using large amounts of a Johnson & Johnson foot ulcer medication could heighten their risk of dying from cancer. The FDA added its most serious warning to the company's Source: www.cnbc.com FDA: Mpls. seafood company violated safety laws - KSTP MINNEAPOLIS (AP) - The federal Food and Drug Administration says a Minneapolis seafood processor has violated food safety laws. The FDA says Captain's Select Seafood Inc. has an extensive history of violating the Federal Food, Drug and Cosmetic Act Source: kstp.com FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding 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. Manufacturer Removes Remaining Stocks of Trasylol Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician�s stock. The FDA will work with Bayer to ensure a smooth and complete process. Mommy's Bliss Nipple Cream Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. Trasylol (aprotinin injection) Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. FDA Requests Recall of Xiadafil VIP Tabs The U.S. Food and Drug Administration today requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. 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. 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. June 5, 2008New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care
HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). 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 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. Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6) Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution. Fresca Italia, Inc., Recalls Burrata Because of Possible Health Risk (May 30) Fresca Italia of Brisbane, CA is recalling Burrata 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 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. 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. FDA Returns ProHeart 6 To The Marketplace - Post Chronicle FDA Returns ProHeart 6 To The Marketplace - Post Chronicle
The U.S. Food and Drug Administration has announced a limited return of ProHeart 6, a reformulated heartworm prevention drug for dogs. The drug -- produced by Ford Dodge Animal Health of Overland Park, Kan., a part of the Wyeth Pharmaceutical Co Source: www.postchronicle.com Trasylol (aprotinin injection) Trasylol (aprotinin injection)
Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. 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. Novartis' bone-building drug gets new FDA approval - CNN Money Novartis' bone-building drug gets new FDA approval - CNN Money
NEW YORK (Associated Press) - Drug developer Novartis AG said Thursday the Food and Drug Administration approved the bone-building drug Reclast as a treatment to prevent additional fractures following a hip fracture. The once-yearly drug is already Source: money.cnn.com FDA Probes Arthritis, Crohn's Drugs for Cancer Link - FOX News Federal regulators are investigating whether a group of best-selling arthritis drugs made by Abbott Laboratories, Schering-Plough Corp. and other companies heighten the risk of cancer in youngsters. The Food and Drug Administration said Wednesday it Source: www.foxnews.com FDA Issues Warning About Contaminated Tomatoes - KOAT 7 A salmonella outbreak across New Mexico and Texas, which is being blamed on bad tomatoes, may change the buying habits of people in both states. Forty people have been sickened by the bacteria in New Mexico since May 3. Another 17 other people have Source: www.koat.com New Drug Application Filing for Levoleucovorin Tablets Completed by - MSN MoneyCentral Spectrum Pharmaceuticals, Inc. SPPI today announced that it has completed its filing with the U.S. Food and Drug Administration (FDA) with the filing of an amendment to the New Drug Application (NDA) for Levoleucovorin Tablets. Levoleucovorin for Source: news.moneycentral.msn.com Mercury teeth fillings may harm some: U.S. FDA - OpEdNews.com Silver-colored metal dental fillings contain mercury that may cause health problems in pregnant women, children and fetuses, the Food and Drug Administration said on Wednesday after settling a related lawsuit. As part of the settlement with several Source: www.opednews.com Viropharma Comments On Upcoming FDA Advisory Committee Meeting - Forbes EXTON, Pa., June 5 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) notes that FDA has published a notice of a meeting of its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology to be held on July 23, 2008. The Source: www.forbes.com FDA: Mercury Dental Fillings May Be Harmful - NewsMax.com Silver-colored metal dental fillings contain mercury that may cause health problems in pregnant women, children and fetuses, the Food and Drug Administration said on Wednesday after settling a related lawsuit. As part of the settlement with several Source: www.newsmax.com Group petitions FDA to ban some food colorings - Los Angeles Times WASHINGTON -- A consumer advocacy group called on the Food and Drug Administration Tuesday to ban the use of eight artificial colorings in food because the additives may cause hyperactivity and behavior problems in some children. Controlled studies Source: www.latimes.com Chantix (varenicline) Chantix (varenicline)
UPDATE - Prescribing information revised to include safety information regarding serious neuropsychiatric symptoms in the WARNINGS and PRECAUTIONS sections of the label. Additionally, a Medication Guide for patients is available. Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) FDA investigating TNF blockers and cancer risk in children and young adults. FDA Approves New Formulation of Coagulation Therapy he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years. 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. Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc. Mommy's Bliss Nipple Cream Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. FDA Approves Entereg to Help Restore Bowel Function Following Surgery The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses. Current Drug Shortage: Neupro (rotigotine transdermal system) UCB is preparing to recall all Neupro lots in the U.S. by May 2008 Drug to be Discontinued: Geocillin (carbenicillin indanyl sodium) tablets 382 mg Pfizer has discontinued this product. There are no other FDA approved manufacturers currently for carbenicillin tablets. Recalls and Safety Alerts: FDA Studying Potential Safety Issues with Several Drugs 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... 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... Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). Important Information about Albuterol Metered Dose Inhalers (MDIs) After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information) Drug to be Discontinued: Geocillin (carbenicillin indanyl sodium) tablets 382 mg Pfizer has discontinued this product. There are no other FDA approved manufacturers currently for carbenicillin tablets. Drug to be Discontinued: Tilade Inhaler (nedocromil sodium inhalation aerosol) Dear Healthcare Professional Letter is available. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial June 4, 2008Canadian officials issue tomato alert - Windsor Star Canadian officials issue tomato alert - Windsor Star
OTTAWA - The Canadian Food Inspection Agency has issued an alert about an outbreak of salmonella contamination in certain types of uncooked tomatoes in the United States. There have been no reported illnesses in Canada, but CFIA is monitoring the Source: www.canada.com Investigators: Patients in China drug deaths were critically ill - Xinhua News Agency NANCHANG, June 5 (Xinhua) -- An investigation into six deaths linked to injections of human immunoglobulin in the eastern province of Jiangxi has found that five patients were critically ill when they received the shots late last month Source: news.xinhuanet.com Group petitions FDA to ban some food colorings - Los Angeles Times WASHINGTON -- A consumer advocacy group called on the Food and Drug Administration Tuesday to ban the use of eight artificial colorings in food because the additives may cause hyperactivity and behavior problems in some children. Controlled studies Source: www.latimes.com FDA Probes Drugs' Risk for Youths - Wall Street Journal The Food and Drug Administration is investigating whether a group of big-selling drugs for arthritis and Crohn's disease heighten the risk of cancer in children and adolescents. The four drugs under scrutiny are biologic treatments known as tumor Source: online.wsj.com Mercury teeth fillings may harm some: FDA - Reuters WASHINGTON (Reuters) - Silver-colored metal dental fillings contain mercury that may cause health problems in pregnant women, children and fetuses, the Food and Drug Administration said on Wednesday after settling a related lawsuit. As part of the Source: www.reuters.com 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. Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) FDA investigating TNF blockers and cancer risk in children and young adults. 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. Contaminated Nipple Cream Contaminated Nipple Cream
FDA is warning nursing mothers not to buy or use Mommy's Bliss Nipple Cream because it contains potentially harmful ingredients. Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic) FDA issues an FDA Alert and Information for Healthcare Professional sheet for Mycophenolate Mofetil (MMF) and Mycophenolic Acid (MPA). 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. 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. FDA Safety Update: Asthma Medications May is Asthma and Allergy Awareness Month. Here is a roundup of recent safety issues related to asthma medications. Sentinel System to Monitor Medical Product Safety FDA's new Sentinel Initiative aims to establish a national electronic system for tracking medical product performance. 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. 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. 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. Group petitions FDA to ban some food colorings - Los Angeles Times Group petitions FDA to ban some food colorings - Los Angeles Times
WASHINGTON -- A consumer advocacy group called on the Food and Drug Administration Tuesday to ban the use of eight artificial colorings in food because the additives may cause hyperactivity and behavior problems in some children. Controlled studies Source: www.latimes.com FDA Starts Safety Review of Autoimmune Disorder Drugs - BusinessWeek WEDNESDAY, June 4 (HealthDay News) -- U.S. health officials have started a safety review of a class of drugs known as tumor necrosis factor (TNF) blockers, which are widely prescribed to treat autoimmune disorders such as rheumatoid arthritis Source: www.businessweek.com Group petitions FDA to ban some food colorings - Forbes A consumer advocacy group called on the Food and Drug Administration Tuesday to ban the use of eight artificial colorings in food because the additives may cause hyperactivity and behavior problems in some children. Controlled studies conducted over Source: www.forbes.com US probes cancer in children given arthritis drugs - Guardian Unlimited The FDA said it asked the makers of Remicade, Enbrel and Humira for information on all cases of cancer reported in children and young adults treated with the drugs. Source: www.guardian.co.uk AstraZeneca submits an sNDA for Symbicort for treatment of asthma in - Genetic Engineering News Wilmington, DE June 4, 2008 AstraZeneca (NYSE: AZN) today announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for SYMBICORT® (budesonide/formoterol Source: www.genengnews.com Indevus shares plunge on testosterone drug delay - Forbes Shares of Indevus Pharmaceuticals Inc. plunged Wednesday after the company said its injectable testosterone drug candidate will face a regulatory delay of up to two years with the Food and Drug Administration because of safety concerns. The Lexington Source: www.forbes.com FDA Reviewing Arthritis Drugs For Cancer Link - CBS News (AP) Federal regulators are investigating whether a group of best-selling arthritis drugs made by Abbott Laboratories, Schering-Plough Corp. and other companies heighten the risk of cancer in youngsters. The Food and Drug Administration said Source: www.cbsnews.com Mercury teeth fillings may harm some: FDA - Reuters WASHINGTON (Reuters) - Silver-colored metal dental fillings contain mercury that may cause health problems in pregnant women, children and fetuses, the Food and Drug Administration said on Wednesday after settling a related lawsuit. As part of the Source: www.reuters.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. 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. Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007. Little Bay Baking Company Issues Nationwide Allergy Alert On Undeclared Soy In Corn Bread And Muffin Mix in 12.6 Ounce White Paper Tin Tie Bag Package (May 2) Little Bay Baking Company of Newmarket, New Hampshire is recalling all bags of CORN BREAD AND MUFFIN MIX sold before May 2, 2008 because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products. June 2008 Patient Safety News Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Seattle Genetics says lymphoma drug showed strong results - Seattle Times Seattle Genetics says lymphoma drug showed strong results - Seattle Times
SGN-35 likely to be company's first product to be approved. An experimental drug to treat Hodgkin lymphoma and similar cancers showed a strong patient response in early clinical trials, Seattle Genetics said Tuesday. The Bothell company said that of Source: seattletimes.nwsource.com FDA urged to ban 8 dyes used in food - Boston Globe WASHINGTON - The United States should ban eight food dyes, used in products including General Mills Inc.'s Lucky Charms cereal, because of links to hyperactivity and other disruptive behavior in children, a health advocacy group said. The Center for Source: www.boston.com FDA's Brain Drain Clogs Process - Hartford Courant WASHINGTON — - When pharmaceutical consulting firm Quintiles wants to hire a new employee, the first place it looks is the Food and Drug Administration. These former insiders bring crucial expertise to the consultant and to clients like Merck & Co Source: www.courant.com FDA approves new, tiny heart pump - United Press International DANVERS, Mass., June 4 (UPI) -- Medical technology company Abiomed Inc. has announced U.S. Food and Drug Administration approval of its Impella 2.5 Cardiac Assist Device heart pump. "FDA clearance of the Abiomed Impella 2.5 represents the next step Source: www.upi.com Food dye rebellion may color U.S. action - Chicago Tribune Spurred on by a successful revolt against artificial food dyes in the United Kingdom, a prominent U.S. food safety advocacy group Tuesday called on federal regulators to ban several colorings, claiming they're linked to hyperactivity in children Source: www.chicagotribune.com Sanofi-Aventis anti-obesity drug cited by UK regulator in 5 deaths - Forbes PARIS (Thomson Financial) - Sanofi-Aventis anti-obesity drug Acomplia has been cited in relation to five deaths and 720 adverse drug reactions in the UK, according to figures published on Tuesday by the Medicines and Healthcare products Regulatory Source: www.forbes.com Antiobesity Drug Linked to Deaths - Wall Street Journal LONDON -- Sanofi-Aventis SA's antiobesity pill Acomplia has been linked to the deaths of five patients, according to findings by the United Kingdom's drug regulator, raising concerns about the controversial treatment and another similar medicine. One Source: online.wsj.com Canadian officials issue tomato alert - Regina Leader-Post OTTAWA - The Canadian Food Inspection Agency has issued an alert about an outbreak of salmonella contamination in certain types of uncooked tomatoes in the United States. There have been no reported illnesses in Canada, but CFIA is monitoring the Source: www.canada.com FDA reviewing arthritis drugs for cancer link - MSNBC WASHINGTON - Federal regulators are investigating whether a group of best-selling arthritis drugs made by Abbott Laboratories, Schering-Plough Corp. and other companies heighten the risk of cancer in youngsters. The Food and Drug Administration said Source: www.msnbc.msn.com India's Ipca gets U.S. FDA approval for propranolol hydrochloride - Forbes MUMBAI (Thomson Financial) - Ipca Laboratories Ltd. said it received approval from the U.S. Food and Drug Administration to make propranolol hydrochloride tablets, used in the treatment of high blood pressure and angina pectoris. The tablet has Source: www.forbes.com Antiobesity Drug Linked to Deaths - Wall Street Journal Antiobesity Drug Linked to Deaths - Wall Street Journal
LONDON -- Sanofi-Aventis SA's antiobesity pill Acomplia has been linked to the deaths of five patients, according to findings by the United Kingdom's drug regulator, raising concerns about the controversial treatment and another similar medicine. One Source: online.wsj.com Canadian officials issue tomato alert - Regina Leader-Post OTTAWA - The Canadian Food Inspection Agency has issued an alert about an outbreak of salmonella contamination in certain types of uncooked tomatoes in the United States. There have been no reported illnesses in Canada, but CFIA is monitoring the Source: www.canada.com FDA urged to ban 8 dyes used in food - Boston Globe WASHINGTON - The United States should ban eight food dyes, used in products including General Mills Inc.'s Lucky Charms cereal, because of links to hyperactivity and other disruptive behavior in children, a health advocacy group said. The Center for Source: www.boston.com Food dye rebellion may color U.S. action - Chicago Tribune Spurred on by a successful revolt against artificial food dyes in the United Kingdom, a prominent U.S. food safety advocacy group Tuesday called on federal regulators to ban several colorings, claiming they're linked to hyperactivity in children Source: www.chicagotribune.com India's Ipca gets U.S. FDA approval for propranolol hydrochloride - Forbes MUMBAI (Thomson Financial) - Ipca Laboratories Ltd. said it received approval from the U.S. Food and Drug Administration to make propranolol hydrochloride tablets, used in the treatment of high blood pressure and angina pectoris. The tablet has Source: www.forbes.com Seattle Genetics says lymphoma drug showed strong results - Seattle Times SGN-35 likely to be company's first product to be approved. An experimental drug to treat Hodgkin lymphoma and similar cancers showed a strong patient response in early clinical trials, Seattle Genetics said Tuesday. The Bothell company said that of Source: seattletimes.nwsource.com FDA reviewing arthritis drugs for cancer link - CNBC FDA reviewing arthritis drugs for cancer link - CNBC
WASHINGTON - Federal regulators are investigating whether a group of best-selling arthritis drugs made by Abbott Laboratories, Schering-Plough Corp. and other companies heighten the risk of cancer in youngsters. The Food and Drug Administration said Source: www.cnbc.com FDA probes cancer in children given arthritis drugs - Reuters WASHINGTON (Reuters) - U.S. health officials are investigating whether drugs used to treat rheumatoid arthritis and Crohn's disease are linked to cases of lymphoma and other cancers in children and young adults, the Food and Drug Administration said Source: www.reuters.com Indevus expects FDA to request additional Nebido safety data - Forbes BOSTON (Thomson Financial) - Indevus Pharmaceuticals Inc. Wednesday said it expects the Food and Drug Administration to formally request additional safety data prior to approving Nebido, a long-acting testosterone depot preparation. Indevus said it Source: www.forbes.com Draeger’s new ventilator gets FDA nod - Philadelphia Inquirer Draeger Medical Inc. announced today that it has received clearance from the Food and Drug Administration to market a new ventilator to the U.S. market. The device, called the Carina ventilator, has both invasive and non-invasive capabilities. The Source: www.philly.com FDA probes cancer in kids given arthritis drugs - Reuters UK WASHINGTON (Reuters) - U.S. health officials are investigating whether drugs used to treat rheumatoid arthritis and Crohn's disease may have contributed to cases of lymphoma and other cancers in children and young adults, the Food and Drug Source: uk.reuters.com Indevus Pharma Slides on FDA Delay - Street.Com Efforts by Indevus Pharmaceuticals IDEV to land U.S. approval for a long-acting testosterone have been delayed by two years, news that sent the stock falling to a new 52-week low Wednesday morning. The Lexington, Mass.-based specialty pharmaceutical Source: www.thestreet.com FDA to study if link exists between childhood cancer and Abbott's - Chicago Tribune Due to a possible link to certain cancers in children, the U.S. Food and Drug Administration this morning said it was conducting a safety review of Abbott Laboratories ' blockbuster rheumatoid arthritis drug Humira and similar drugs known as "tumor Source: www.chicagotribune.com 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. Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). Cardinal Alcohol-Free Mouthwash Additional lot recalled because of the presence of Burkholderia cepacia. 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. 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. Drug to be Discontinued: Geocillin (carbenicillin indanyl sodium) tablets 382 mg Pfizer has discontinued this product. There are no other FDA approved manufacturers currently for carbenicillin tablets. 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. 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. Heparin Sodium Injection FDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available for patient use. Ipca labs to manufacture drug for US market - Business Standard Ipca labs to manufacture drug for US market - Business Standard
Ipca Laboratories has received approval from US Food and Drugs Administration to manufacture Propranolol Hydrochloride Tablets USP 10 mg, 20 mg, 40 mg, 60 mg and 80 mg for the US market. The company informed the Bombay Stock Exchange that it will Source: www.business-standard.com FDA urged to ban 8 dyes used in food - Boston Globe WASHINGTON - The United States should ban eight food dyes, used in products including General Mills Inc.'s Lucky Charms cereal, because of links to hyperactivity and other disruptive behavior in children, a health advocacy group said. The Center for Source: www.boston.com Antiobesity Drug Linked to Deaths - Wall Street Journal LONDON -- Sanofi-Aventis SA's antiobesity pill Acomplia has been linked to the deaths of five patients, according to findings by the United Kingdom's drug regulator, raising concerns about the controversial treatment and another similar medicine. One Source: online.wsj.com Call to Ban Certain Food Colors Save Email Print - WHSV A consumer group is asking the Food and Drug Administration to ban the use of eight artificial food colorings. The Center for Science in the Public Interest claims that the dyes can lead to hyperactivity and behavior problems in children. The center Source: www.whsv.com India's Ipca gets U.S. FDA approval for propranolol hydrochloride - Forbes MUMBAI (Thomson Financial) - Ipca Laboratories Ltd. said it received approval from the U.S. Food and Drug Administration to make propranolol hydrochloride tablets, used in the treatment of high blood pressure and angina pectoris. The tablet has Source: www.forbes.com U.S. probing Salmonella outbreak in 9 states - Reuters U.S. probing Salmonella outbreak in 9 states - Reuters
CHICAGO (Reuters) - Health authorities are looking into an outbreak of Salmonella food poisoning in U.S. nine states, with illnesses blamed in two of the states, Texas and New Mexico, on eating raw tomatoes, officials said on Tuesday. The U.S. Food Source: www.reuters.com Antiobesity Drug Linked to Deaths - Wall Street Journal LONDON -- Sanofi-Aventis SA's antiobesity pill Acomplia has been linked to the deaths of five patients, according to findings by the United Kingdom's drug regulator, raising concerns about the controversial treatment and another similar medicine. One Source: online.wsj.com Ipca labs to manufacture drug for US market - Business Standard Ipca Laboratories has received approval from US Food and Drugs Administration to manufacture Propranolol Hydrochloride Tablets USP 10 mg, 20 mg, 40 mg, 60 mg and 80 mg for the US market. The company informed the Bombay Stock Exchange that it will Source: www.business-standard.com Call to Ban Certain Food Colors Save Email Print - WHSV A consumer group is asking the Food and Drug Administration to ban the use of eight artificial food colorings. The Center for Science in the Public Interest claims that the dyes can lead to hyperactivity and behavior problems in children. The center Source: www.whsv.com India's Ipca gets U.S. FDA approval for propranolol hydrochloride - Forbes MUMBAI (Thomson Financial) - Ipca Laboratories Ltd. said it received approval from the U.S. Food and Drug Administration to make propranolol hydrochloride tablets, used in the treatment of high blood pressure and angina pectoris. The tablet has Source: www.forbes.com FDA urged to ban 8 dyes used in food - Boston Globe WASHINGTON - The United States should ban eight food dyes, used in products including General Mills Inc.'s Lucky Charms cereal, because of links to hyperactivity and other disruptive behavior in children, a health advocacy group said. The Center for Source: www.boston.com Seattle Genetics says lymphoma drug showed strong results - Seattle Times SGN-35 likely to be company's first product to be approved. An experimental drug to treat Hodgkin lymphoma and similar cancers showed a strong patient response in early clinical trials, Seattle Genetics said Tuesday. The Bothell company said that of Source: seattletimes.nwsource.com Sanofi-Aventis anti-obesity drug cited by UK regulator in 5 deaths - Forbes PARIS (Thomson Financial) - Sanofi-Aventis anti-obesity drug Acomplia has been cited in relation to five deaths and 720 adverse drug reactions in the UK, according to figures published on Tuesday by the Medicines and Healthcare products Regulatory Source: www.forbes.com Consumer group asks FDA to bar 8 food dyes - Fort Lauderdale Sun-Sentinel WASHINGTON - A consumer advocacy group called on the Food and Drug Administration Tuesday to ban the use of eight artificial colorings in food because the additives may cause hyperactivity and behavior problems in some children. Controlled studies Source: www.sun-sentinel.com Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardiopulmonary Bypass Surgery (May 12) 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. 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. Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern (Red Only) Stoneware Dinnerware Product Lines (April 28) Lifetime Brands, Inc., of Garden City, New York, today announced that, as a result of its internal compliance and independent product testing programs, it recently became aware that certain Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern stoneware dinnerware products may exceed the Food and Drug Administration's guidance levels for lead and/or cadmium. Fresca Italia, Inc., Recalls Burrata Because of Possible Health Risk (May 30) Fresca Italia of Brisbane, CA is recalling Burrata 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. 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... Consumer group asks FDA to bar 8 food dyes - Fort Lauderdale Sun-Sentinel Consumer group asks FDA to bar 8 food dyes - Fort Lauderdale Sun-Sentinel
WASHINGTON - A consumer advocacy group called on the Food and Drug Administration Tuesday to ban the use of eight artificial colorings in food because the additives may cause hyperactivity and behavior problems in some children. Controlled studies Source: www.sun-sentinel.com India's Ipca gets U.S. FDA approval for propranolol hydrochloride - Forbes MUMBAI (Thomson Financial) - Ipca Laboratories Ltd. said it received approval from the U.S. Food and Drug Administration to make propranolol hydrochloride tablets, used in the treatment of high blood pressure and angina pectoris. The tablet has Source: www.forbes.com FDA urged to ban 8 dyes used in food - Boston Globe WASHINGTON - The United States should ban eight food dyes, used in products including General Mills Inc.'s Lucky Charms cereal, because of links to hyperactivity and other disruptive behavior in children, a health advocacy group said. The Center for Source: www.boston.com FDA Approves New Formulation of Coagulation Therapy FDA Approves New Formulation of Coagulation Therapy
he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years. 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. FDA Takes Action against Cream Cheese Companies, Executives The U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, until they are found compliant with food-safety laws. Manufacturer Removes Remaining Stocks of Trasylol Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician�s stock. The FDA will work with Bayer to ensure a smooth and complete process. FDA Approves First Generic Ropinirole The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome. 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. Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007. 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. Start at the Store: 7 Ways to Prevent Foodborne Illness Food safety for consumers should begin at the supermarket or grocery store. Here are useful hints to keep in mind when shopping for food that will help keep foodborne illnesses out of your home. Combating Antibiotic Resistance Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics. June 3, 2008Strengthening Beef Safety Strengthening Beef Safety
An FDA regulation further protects consumers of beef against mad cow disease. FDA Takes Action against Cream Cheese Companies, Executives The U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, until they are found compliant with food-safety laws. FDA Approves New Formulation of Coagulation Therapy he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years. FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products. FDA Approves Entereg to Help Restore Bowel Function Following Surgery The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses. 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 Recall of Xiadafil VIP Tabs The U.S. Food and Drug Administration today requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. 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. Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled
The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007. 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... 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... Little Bay Baking Company Issues Nationwide Allergy Alert On Undeclared Soy In Corn Bread And Muffin Mix in 12.6 Ounce White Paper Tin Tie Bag Package (May 2) Little Bay Baking Company of Newmarket, New Hampshire is recalling all bags of CORN BREAD AND MUFFIN MIX sold before May 2, 2008 because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products. 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. 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... Group petitions FDA to ban some food colorings - Chicago Tribune Group petitions FDA to ban some food colorings - Chicago Tribune
WASHINGTON - A consumer advocacy group called on the Food and Drug Administration Tuesday to ban the use of eight artificial colorings in food because the additives may cause hyperactivity and behavior problems in some children. Controlled studies Source: www.chicagotribune.com C5 Medical Werks Receives FDA Clearance and CE Certification for Its - Forbes DENVER, June 2 /PRNewswire/ -- C5 Medical Werks, a manufacturer of high-quality ceramic solutions for the medical device industry, has received clearance from the U.S. Food and Drug Administration (FDA) to market the Company's ZirDent(TM) CAD/CAM Source: www.forbes.com FDA approves Abiomed's heart pump Impella, shares rise - Reuters (Reuters) - Medical device maker Abiomed Inc (ABMD.O: Quote , Profile , Research ) said U.S. health regulators approved the sale of its heart pump, Impella 2.5, driving its shares up about 24 percent to their highest in more than six years. Impella 2 Source: www.reuters.com Antiobesity Drug Linked to Deaths - Wall Street Journal LONDON -- Sanofi-Aventis SA's antiobesity pill Acomplia has been linked to the deaths of five patients, according to findings by the United Kingdom's drug regulator, raising concerns about the controversial treatment and another similar medicine. One Source: online.wsj.com Abiomed: FDA OKs 'world's smallest heart pump' - Forbes Abiomed Inc. said Monday it received 510(k) clearance from the Food and Drug Administration to sell its Impella 2.5 heart pump, sending shares soaring in early trading. Approval of the device, which is a catheter pump that facilitates blood flow Source: www.forbes.com Consumer Group Urges Ban On Artificial Food Colorings - Wall Street Journal WASHINGTON -- A consumer-advocacy group called on the Food and Drug Administration to ban the use of eight artificial colorings in food because the additives may cause hyperactivity and behavior problems in some children. Studies conducted over three Source: online.wsj.com FDA clears heart pump from Danvers-based Abiomed - Boston Globe DANVERS, Mass.— Federal regulators have approved an implanted device used to maintain blood flow in heart failure patients during and after surgery, sending shares of developer Abiomed Inc. up sharply. Abiomed said Monday that the U.S. Food and Source: www.boston.com Group petitions FDA to ban some food colorings - Seattle Times A consumer advocacy group called on the Food and Drug Administration Tuesday to ban the use of eight artificial colorings in food because the additives may cause hyperactivity and behavior problems in some children. Controlled studies conducted over Source: seattletimes.nwsource.com U.S. probing Salmonella outbreak in 9 states - Reuters U.S. probing Salmonella outbreak in 9 states - Reuters
CHICAGO (Reuters) - Health authorities are looking into an outbreak of Salmonella food poisoning in U.S. nine states, with illnesses blamed in two of the states, Texas and New Mexico, on eating raw tomatoes, officials said on Tuesday. The U.S. Food Source: www.reuters.com Antiobesity Drug Linked to Deaths - Wall Street Journal LONDON -- Sanofi-Aventis SA's antiobesity pill Acomplia has been linked to the deaths of five patients, according to findings by the United Kingdom's drug regulator, raising concerns about the controversial treatment and another similar medicine. One Source: online.wsj.com Cardinal Alcohol-Free Mouthwash Cardinal Alcohol-Free Mouthwash
Additional lot recalled because of the presence of Burkholderia cepacia. 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. Invitrogen Receives FDA Clearance for Diagnostic System to Determine - MSN MoneyCentral Invitrogen Receives FDA Clearance for Diagnostic System to Determine - MSN MoneyCentral
Invitrogen Corporation IVGN , a provider of essential life science technologies for research, production and diagnostics, today announced it received U.S. Food and Drug Administration (FDA) clearance for its DynaChip ™ Antibody Analysis System. The Source: news.moneycentral.msn.com Manufacturer Removes Remaining Stocks of Trasylol Manufacturer Removes Remaining Stocks of Trasylol
Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician�s stock. The FDA will work with Bayer to ensure a smooth and complete process. FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products. Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc. 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. 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 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. Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2) Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash. Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007. New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. FDA Approves Entereg to Help Restore Bowel Function Following Surgery The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses. Former HealthSouth CEO appeals conviction - Salon Former HealthSouth CEO appeals conviction - Salon
Jun 3rd, 2008 | MONTGOMERY, Ala. -- Former HealthSouth CEO Richard Scrushy is asking a federal appeals court to overturn his conviction in a government corruption case. The appeal was filed late Monday in the 11th U.S. Circuit Court of Appeals Source: www.salon.com Resolved Drug Shortage: Lymphazurin 1% injection (isosulfan blue) Resolved Drug Shortage: Lymphazurin 1% injection (isosulfan blue)
Covidien now has Lymphazurin 1% injection available. Drug to be Discontinued: Geocillin (carbenicillin indanyl sodium) tablets 382 mg Pfizer has discontinued this product. There are no other FDA approved manufacturers currently for carbenicillin 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... 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... Trasylol (aprotinin injection) Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. Important Information about Albuterol Metered Dose Inhalers (MDIs) After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information) Latest drug scare in China sees six dead - News-Medical.Net Latest drug scare in China sees six dead - News-Medical.Net
Human immunoglobulins are proteins produced by the body and are used in the treatment of autoimmune diseases, when the body turns on itself and attacks its own cells. The six were reportedly injected between May 22nd and 28th and the Chinese Source: www.news-medical.net The Aethlon Hemopurifier(R) Proves Effective in Capturing the - MSN MoneyCentral Aethlon Medical, Inc. AEMD announced today that the Aethlon Hemopurifier ® has proven effective in capturing the reconstructed Spanish Flu of 1918 virus (1918rv). During in vitro testing, high concentrations of 1918rv were rapidly depleted from cell Source: news.moneycentral.msn.com Latest drug scare in China sees six dead - News-Medical.Net Latest drug scare in China sees six dead - News-Medical.Net
Human immunoglobulins are proteins produced by the body and are used in the treatment of autoimmune diseases, when the body turns on itself and attacks its own cells. The six were reportedly injected between May 22nd and 28th and the Chinese Source: www.news-medical.net Acorda announces positive Phase III results for multiple-sclerosis - CNBC LONDON (Thomson Financial) - Acorda Therapeutics Inc. on Monday announced positive results for the second Phase III clinical trial for its drug Fampridine-SR, used in the treatment of multiple sclerosis. The company said a significantly greater Source: www.cnbc.com Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2) Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2)
Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash. 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. Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007. 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. Lifetime Brands Voluntarily Recalls Certain Items Nationwide from its Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern (Red Only) Stoneware Dinnerware Product Lines (April 28) Lifetime Brands, Inc., of Garden City, New York, today announced that, as a result of its internal compliance and independent product testing programs, it recently became aware that certain Pfaltzgraff Villa della Luna pattern and Nautica J Class pattern stoneware dinnerware products may exceed the Food and Drug Administration's guidance levels for lead and/or cadmium. 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. Little Bay Baking Company Issues Nationwide Allergy Alert On Undeclared Soy In Corn Bread And Muffin Mix in 12.6 Ounce White Paper Tin Tie Bag Package (May 2) Little Bay Baking Company of Newmarket, New Hampshire is recalling all bags of CORN BREAD AND MUFFIN MIX sold before May 2, 2008 because it contains undeclared soy. People who have an allergy or severe sensitivity to soy 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. 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. 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. 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. 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. 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. 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. June 2, 2008FDA: Time for Asthma Patients to Switch Inhalers - FOX News FDA: Time for Asthma Patients to Switch Inhalers - FOX News
Old-fashioned asthma inhalers that contain environment-harming chemicals will no longer be sold at year's end — and the government is urging patients not to wait until the last minute to switch to newer alternatives. Patients use inhalers to Source: www.foxnews.com FDA clears heart pump from Abiomed - MSN MoneyCentral DANVERS, Mass. (AP) - Federal regulators have approved an implanted device used to maintain blood flow in heart failure patients during and after surgery. The news has sent shares of developer Abiomed Inc. up sharply. Abiomed said Monday that the U.S Source: moneycentral.msn.com FDA Approves Spray-On Estrogen to Treat Menopause - FOX News FDA Approves Spray-On Estrogen to Treat Menopause - FOX News
The Food and Drug Administration has approved a form of spray-on estrogen called Evamist, which treats moderate to severe menopausal symptoms; it is being reported in Obstetrics & Gynecology. Evamist contains estrodial in ethanol and is formulated to Source: www.foxnews.com FDA clears heart pump from Danvers-based Abiomed - Boston Globe DANVERS, Mass.— Federal regulators have approved an implanted device used to maintain blood flow in heart failure patients during and after surgery, sending shares of developer Abiomed Inc. up sharply. Abiomed said Monday that the U.S. Food and Source: www.boston.com Abiomed gets FDA 501(k) clearance for Imeplla 2.5 cardiac assist - Forbes BOSTON (Thomson Financial) - Abiomed Inc. Monday said it has received a 501(k) clearance from the Food and Drug Administration for its Impella 2.5 cardiac assist device. The 510(k) clearance allows Abiomed to begin selling the heart pump to Source: www.forbes.com Abiomed: FDA OKs 'world's smallest heart pump' - Forbes Abiomed Inc. said Monday it received 510(k) clearance from the Food and Drug Administration to sell its Impella 2.5 heart pump, sending shares soaring in early trading. Approval of the device, which is a catheter pump that facilitates blood flow Source: www.forbes.com FDA: Time for Asthma Patients to Switch Inhalers - FOX News Old-fashioned asthma inhalers that contain environment-harming chemicals will no longer be sold at year's end — and the government is urging patients not to wait until the last minute to switch to newer alternatives. Patients use inhalers to Source: www.foxnews.com Velcera Announces Positive FDA Meeting on VEL504 Product - MSN MoneyCentral Velcera, Inc. (OTCBB: VLCR), a specialty pharmaceutical company focused on pet health, announced today positive results from its presubmission conference with the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM) concerning Source: news.moneycentral.msn.com FDA clears heart pump from Abiomed - MSN MoneyCentral DANVERS, Mass. (AP) - Federal regulators have approved an implanted device used to maintain blood flow in heart failure patients during and after surgery. The news has sent shares of developer Abiomed Inc. up sharply. Abiomed said Monday that the U.S Source: moneycentral.msn.com FDA approves Abiomed's heart pump Impella, shares rise - Reuters (Reuters) - Medical device maker Abiomed Inc (ABMD.O: Quote , Profile , Research ) said U.S. health regulators approved the sale of its heart pump, Impella 2.5, driving its shares up about 24 percent to their highest in more than six years. Impella 2 Source: www.reuters.com UPDATE 1-EU agency backs Schering-Plough anaesthesia drug - Reuters UPDATE 1-EU agency backs Schering-Plough anaesthesia drug - Reuters
LONDON, June 2 (Reuters) - A new drug from Schering-Plough Corp (SGP.N: Quote , Profile , Research ) aimed at helping patients emerge more quickly from anesthesia has been recommended for approval in Europe, the region's medicines watchdog said on Source: www.reuters.com Solvay reports positive cholesterol drug trials - Reuters BRUSSELS, June 2 (Reuters) - Belgian drugs and chemicals maker Solvay (SOLB.BR: Quote , Profile , Research ) said on Monday that the third of three phase III trials of its cholesterol-fighting drug TriLipix in combination with other drugs had proved Source: www.reuters.com 6 Die After Receiving Human Antibody Injections in China - FOX News BEIJING — Six people have died after being injected with a human antibody in eastern China, a hospital spokeswoman said Monday, the latest case of deaths caused by suspect medicine. The six died after being injected with immune globulin, and the Source: www.foxnews.com Lannett Company to Launch Amantadine Hydrochloride Soft Gel Capsules - MSN MoneyCentral Lannett Company, Inc. LCI , a manufacturer of generic pharmaceuticals, today said that it expects to commence marketing Amantadine Hydrochloride Soft Gel Capsules 100mg, within the next several months. According to Wolters Kluwer, annual sales in Source: news.moneycentral.msn.com European panel backs Schering-Plough post-op drug - CNBC European panel backs Schering-Plough post-op drug - CNBC
WASHINGTON (AP) - European regulators recommended approval Monday for a Schering-Plough Corp. drug designed to help patients recover from anesthesia following surgery. Schering said a committee of the European Medicines Agency endorsed its drug Source: www.cnbc.com C5 Medical Werks Receives FDA Clearance and CE Certification for Its - Forbes DENVER, June 2 /PRNewswire/ -- C5 Medical Werks, a manufacturer of high-quality ceramic solutions for the medical device industry, has received clearance from the U.S. Food and Drug Administration (FDA) to market the Company's ZirDent(TM) CAD/CAM Source: www.forbes.com Consumer Groups Angered by FDA and USDA Inaction on CO-treated Meat - Common Dreams WASHINGTON, DC - June 2 - Declaring the government’s two-and-a-half year delay as “inexcusable”, six of the nation’s leading consumer groups urged the Food and Drug Administration and the Department of Agriculture to immediately ban the Source: www.commondreams.org FDA Takes Action Against Scientific Laboratories Inc. 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. 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. Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup (May 6) Blount Fine Foods is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. The firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution. 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. 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. Sentinel System to Monitor Medical Product Safety FDA's new Sentinel Initiative aims to establish a national electronic system for tracking medical product performance. 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. ... 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... 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... 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. 6 die in China after getting antibody injections - FOX News 6 die in China after getting antibody injections - FOX News
BEIJING — Six people have died in eastern China after being injected with medicine commonly used to treat infections such as hepatitis A and rabies, a hospital spokeswoman said Monday. The six died after being injected with immune globulin, and the Source: www.foxnews.com A dose of honesty in prescription drug ads - Boston Globe LAST MONTH, a congressional committee held a hearing to examine the extent to which drug companies run misleading ads about their products. The committee spotlighted TV commercials for three drugs - the cholesterol-lowering drugs Lipitor and Vytorin Source: www.boston.com FDA panel favors Glaxo, Ligand blood drug - NWI.com WASHINGTON - Advisers to the Food and Drug Administration said Friday a blood-clotting drug from GlaxoSmithKline PLC and Ligand Pharmaceuticals Inc. is effective for short-term use, despite reservations by FDA scientists. A panel of 16 outside Source: www.thetimesonline.com ASCO AT A GLANCE: Genetic Research A Focus Of Cancer Meeting - CNN Money THE EVENT: Thousands of cancer specialists are in Chicago this week attending the 44th annual meeting of the American Society of Clinical Oncology, where pharmaceutical and biotech companies are providing updates on 4,200 studies. The five-day ASCO Source: money.cnn.com Narcolepsy drug helps cancer-related fatigue: study - Reuters CHICAGO (Reuters) - The narcolepsy drug Provigil can alleviate severe cancer-related fatigue, according to new research presented on Saturday at a meeting of the American Society for Clinical Oncology. Provigil, or modafinil, is used to treat adults Source: www.reuters.com Infinity to begin phase 3 trial of cancer drug - Reuters NEW YORK, May 31 (Reuters) - Infinity Pharmaceuticals Inc (INFI.O: Quote , Profile , Research ) said on Saturday it plans to begin late-stage testing of its experimental cancer drug for gastrointestinal stromal tumors (GIST) that have failed to Source: www.reuters.com FDA urges patients to switch to new inhalers - Detroit Free Press FDA urges patients to switch to new inhalers - Detroit Free Press
WASHINGTON — Old-fashioned asthma inhalers that contain environment-harming chemicals will quit selling at year’s end — and the government is urging patients not to wait until the last minute to switch to newer alternatives. Patients use Source: www.freep.com India's Cipla gets tentative FDA nod for topiramate - Reuters MUMBAI, June 1 (Reuters) - Indian drugmaker Cipla Ltd (CIPL.BO: Quote , Profile , Research ) has received tentative approval from the U.S. Food and Drug Administration for generic epilepsy drug topiramate tablets, the regulator's website showed Source: www.reuters.com ASCO AT A GLANCE: Genetic Research A Focus Of Cancer Meeting - CNN Money THE EVENT: Thousands of cancer specialists are in Chicago this week attending the 44th annual meeting of the American Society of Clinical Oncology, where pharmaceutical and biotech companies are providing updates on 4,200 studies. The five-day ASCO Source: money.cnn.com FDA panel favors Glaxo, Ligand blood drug - NWI.com WASHINGTON - Advisers to the Food and Drug Administration said Friday a blood-clotting drug from GlaxoSmithKline PLC and Ligand Pharmaceuticals Inc. is effective for short-term use, despite reservations by FDA scientists. A panel of 16 outside Source: www.thetimesonline.com Data from Satraplatin SPARC Phase 3 Trial in Patients with - MSN MoneyCentral GPC Biotech AG (Frankfurt Stock Exchange: GPC, NASDAQ: GPCB) today announced the presentation of the overall survival results from the double-blind, randomized satraplatin Phase 3 registrational trial, the SPARC trial (Satraplatin and Prednisone Source: news.moneycentral.msn.com FDA: Time for asthma patients to switch inhalers - NWITimes.com WASHINGTON - Old-fashioned asthma inhalers that contain environment-harming chemicals will no longer be sold at year's end _ and the government is urging patients not to wait until the last minute to switch to newer alternatives. Patients use Source: nwitimes.com New Data from Several Satraplatin Clinical Trials in Solid Tumors - Forbes GPC Biotech AG (Frankfurt Stock Exchange: GPC, NASDAQ: GPCB) today announced the presentation of data from several satraplatin clinical trials at the 44th Annual Meeting of the American Society for Clinical Oncology (ASCO) in Chicago. "We are pleased Source: www.forbes.com FDA: Switch asthma inhalers - AZCentral.com WASHINGTON - Asthma inhalers that contain environment-harming chemicals will no longer be sold at year's end - and the government is urging patients not to wait until the last minute to switch to newer alternatives. Patients use inhalers to dispense Source: www.azcentral.com Investigational Studies Highlight Potential Utility of Zevalin(R) - MSN MoneyCentral CHICAGO, June 2 /PRNewswire-FirstCall/ -- At the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO), two studies were presented investigating the potential utility of Zevalin(R) (Ibritumomab Tiuxetan) radioimmunotherapy as Source: news.moneycentral.msn.com June 1, 2008Fresca Italia, Inc., Recalls Burrata Because of Possible Health Risk (May 30) Fresca Italia, Inc., Recalls Burrata Because of Possible Health Risk (May 30)
Fresca Italia of Brisbane, CA is recalling Burrata 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 Embarks on Major Hiring Initiative for its Public Health Mission The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation. Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). Controlling Cholesterol with Statins 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. For some, health studies can help pay bills - St. Petersburg Times For some, health studies can help pay bills - St. Petersburg Times
Janet Muchmore, 57, of New Port Richey takes her daily dose of gabapentin as part of a medical trial studying the drug to treat pain in patients who have had shingles. You betcha. Gail Platt, a 61-year-old Safety Harbor grandmother, is a human guinea Source: www.tampabay.com Pet trainer has never met a bad dog - St. Petersburg Times Marilyn Wolf gives Little Momma, a Labrador mix, a treat to reinforce good behavior at the SPCA in New Port Richey. NEW PORT RICHEY — Marilyn Wolf grew up on 3 acres in Indiana farm country. Her parents loved animals and took in a menagerie of Source: www.tampabay.com Six Chinese die after hospital injection - Straits Times BEIJING - SIX people have died in the past 10 days after being injected with human immunoglobulin, proteins that behave like antibodies, at an eastern Chinese hospital, the official Xinhua news agency said, citing local authorities. The victims died Source: www.straitstimes.com Narcolepsy drug helps cancer-related fatigue: study - Reuters CHICAGO (Reuters) - The narcolepsy drug Provigil can alleviate severe cancer-related fatigue, according to new research presented on Saturday at a meeting of the American Society for Clinical Oncology. Provigil, or modafinil, is used to treat adults Source: www.reuters.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 Imclone Gets Targeted - Forbes Biotech investors are focused on new data showing Erbitux, the cancer drug sold by ImClone Systems and Bristol-Myers Squibb, extends the lives of lung cancer patients by five weeks. But another Erbitux-related development may be even more important Source: www.forbes.com Infinity Pharma Drug Shows Response, Moving To Late-Stage - CNN Money CHICAGO -(Dow Jones)- An early stage trial of Infinity Pharmaceuticals Inc.'s (INFI) IPI-504 showed a response in treating patients with a rare but deadly cancer of the stomach and intestines that were previously treated with therapies including Source: money.cnn.com Infinity to begin phase 3 trial of cancer drug - Reuters NEW YORK, May 31 (Reuters) - Infinity Pharmaceuticals Inc (INFI.O: Quote , Profile , Research ) said on Saturday it plans to begin late-stage testing of its experimental cancer drug for gastrointestinal stromal tumors (GIST) that have failed to Source: www.reuters.com Pregnant Women to Benefit from Better 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. Start at the Store: 7 Ways to Prevent Foodborne Illness Food safety for consumers should begin at the supermarket or grocery store. Here are useful hints to keep in mind when shopping for food that will help keep foodborne illnesses out of your home. 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. 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. 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. Sentinel System to Monitor Medical Product Safety FDA's new Sentinel Initiative aims to establish a national electronic system for tracking medical product performance. Cardinal Alcohol-Free Mouthwash Product recalled because of the presence of Burkholderia cepacia. Device Identifies Fatty Deposits in Coronary Arteries A new medical device allows doctors to see the plaque buildup on the wall of coronary arteries. Many heart attacks occur when a fatty coronary plaque ruptures, forming dangerous blood clots. Strengthening Beef Safety An FDA regulation further protects consumers of beef against mad cow disease. Chantix (varenicline) UPDATE - Prescribing information revised to include safety information regarding serious neuropsychiatric symptoms in the WARNINGS and PRECAUTIONS sections of the label. Additionally, a Medication Guide for patients is available. FDA panel favors Glaxo, Ligand blood drug - Forbes FDA panel favors Glaxo, Ligand blood drug - Forbes
Advisers to the Food and Drug Administration said Friday a blood-clotting drug from GlaxoSmithKline PLC and Ligand Pharmaceuticals Inc. is effective for short-term use, despite reservations by FDA scientists. A panel of 16 outside advisers voted Source: www.forbes.com FDA Panel Backs Glaxo Platelet Drug Promacta - Wall Street Journal CHICAGO -- An outside advisory panel recommended Friday that the Food and Drug Administration approve a proposed GlaxoSmithKline PLC drug to treat a blood condition. In a 16-0 vote, the FDA's oncologic drugs advisory committee concluded clinical Source: online.wsj.com Imclone Gets Targeted - Forbes Biotech investors are focused on new data showing Erbitux, the cancer drug sold by ImClone Systems and Bristol-Myers Squibb, extends the lives of lung cancer patients by five weeks. But another Erbitux-related development may be even more important Source: www.forbes.com Imclone Gets Targeted - Forbes Imclone Gets Targeted - Forbes
Biotech investors are focused on new data showing Erbitux, the cancer drug sold by ImClone Systems and Bristol-Myers Squibb, extends the lives of lung cancer patients by five weeks. But another Erbitux-related development may be even more important 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 Analyst: J&J blood-clot drug poised for success - CNBC NEW YORK - The anti-bloodclotting drug Rivaroxaban could help Johnson & Johnson fight off anticipated revenue losses from generic competition, according to a Deutsche Bank-North America analyst. The drug, which treats blood clots after orthopedic Source: www.cnbc.com FDA panel favors Glaxo, Ligand blood drug - Los Angeles Times WASHINGTON -- Advisers to the Food and Drug Administration said Friday a blood-clotting drug from GlaxoSmithKline PLC and Ligand Pharmaceuticals Inc. is effective for short-term use, despite reservations by FDA scientists. A panel of 16 outside Source: www.latimes.com Test may predict cancer response to anemia drugs - Guardian Unlimited CHICAGO, June 1 (Reuters) - A genetic test may help predict whether giving cancer patients anemia drugs could make their cancer worse, U.S. researchers said on Sunday. Over the past year and a half, eight late-stage clinical trials have shown that Source: www.guardian.co.uk J&J blood clot drug beats Sanofi-Aventis' Lovenox - Forbes Johnson & Johnson said Friday its experimental drug to treat blood clots after orthopedic surgery proved more effective in a late-stage trial than a competing drug from Sanofi-Aventis SA which is already on the market. Rivaroxaban, 10 milligrams Source: www.forbes.com Infinity to begin phase 3 trial of cancer drug - Reuters NEW YORK, May 31 (Reuters) - Infinity Pharmaceuticals Inc (INFI.O: Quote , Profile , Research ) said on Saturday it plans to begin late-stage testing of its experimental cancer drug for gastrointestinal stromal tumors (GIST) that have failed to Source: www.reuters.com FDA panel favors Glaxo, Ligand blood drug - Miami Herald Advisers to the Food and Drug Administration said Friday a blood-clotting drug from GlaxoSmithKline and Ligand Pharmaceuticals is effective for short-term use, despite reservations by FDA scientists. A panel of outside advisers voted unanimously in Source: www.miamiherald.com Heating oil sticker shock to hit New England - Newsday PORTLAND, Maine - While people in most of the country may be worried about their summer air conditioning bills, many residents in the Northeast are way beyond that: They're already thinking ahead to next winter's heating bills. And what those who Source: www.newsday.com FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now - WebWire The U.S. Food and Drug Administration today issued a public health advisory to alert patients, caregivers and health care professionals to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled Source: www.webwire.com Important Information about Albuterol Metered Dose Inhalers (MDIs) Important Information about Albuterol Metered Dose Inhalers (MDIs)
After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information) 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. Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic) FDA issues an FDA Alert and Information for Healthcare Professional sheet for Mycophenolate Mofetil (MMF) and Mycophenolic Acid (MPA). Mommy's Bliss Nipple Cream Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. FDA Embarks on Major Hiring Initiative for its Public Health Mission The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation. Trasylol (aprotinin injection) Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). FDA: Time for asthma patients to switch inhalers - CNN Money FDA: Time for asthma patients to switch inhalers - CNN Money
NEW YORK (Associated Press) - Old-fashioned asthma inhalers that contain environment-harming chemicals will no longer be sold at year's end _ and the government is urging patients not to wait until the last minute to switch to newer alternatives Source: money.cnn.com Two lots of baby formula recalled: FDA - Edmonton Journal Abbott Laboratories says it is voluntarily recalling two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder. The formula is specially designed for infants and children with hypercalcemia - high levels of calcium - in their Source: www.canada.com UPDATE 1-FDA panel says data backs use of Glaxo's Promacta - Reuters CHICAGO, May 30 (Reuters) - An expert advisory panel to the U.S. Food and Drug Administration said on Friday that current clinical data supports short-term use of GlaxoSmithKline Plc's (GSK.L: Quote , Profile , Research )(GSK.N: Quote , Profile Source: www.reuters.com Ligand Has Record Gain After FDA Panel Backs Promacta (Update2) - Bloomberg May 30 (Bloomberg) -- Ligand Pharmaceuticals Inc. , the company developing the first oral medicine for a rare bleeding disorder with GlaxoSmithKline Plc , had a record gain in Nasdaq trading after a U.S. panel voted in favor of the drug. Ligand, of Source: www.bloomberg.com PROMACTA(R) (eltrombopag) RECEIVES UNANIMOUS RECOMMENDATION BY FDA - MSN MoneyCentral Panel Votes, 16-0, in Favor of Short-Term Treatment of Chronic Idiopathic Thrombocytopenic Purpura (ITP) CHICAGO, May 30 /PRNewswire-USNewswire/ -- GlaxoSmithKline GSK today announced that the United States Food and Drug Administration's Oncology Source: news.moneycentral.msn.com FDA: Time for Asthma Patients to Get New Inhalers - ABC News Old-fashioned asthma inhalers that contain environment-harming chemicals will quit selling at year's end — and the government is urging patients not to wait until the last minute to switch to newer alternatives. Patients use inhalers that dispense Source: www.abcnews.go.com FDA panel favors Glaxo, Ligand blood drug - Los Angeles Times WASHINGTON -- Advisers to the Food and Drug Administration said Friday a blood-clotting drug from GlaxoSmithKline PLC and Ligand Pharmaceuticals Inc. is effective for short-term use, despite reservations by FDA scientists. A panel of 16 outside Source: www.latimes.com Tainted Drug Imports Set Off Warnings, Not FDA Action (Update2) - Bloomberg May 30 (Bloomberg) -- Two Americans died and 15 suffered seizures. The suspected cause: The epilepsy medicine they depended on stopped working because of a counterfeit ingredient from overseas. The case of the flawed drug, made by a company that no Source: www.bloomberg.com Solodyn (minocycline HCL) Extended Release Tablets 90 mg Solodyn (minocycline HCL) Extended Release Tablets 90 mg
Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). Mommy's Bliss Nipple Cream Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. Updated Press Release: Lezza Blue Raspberry Italian Ice Recalled The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product. The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007. Edwards Lifesciences says FDA has more questions about LifeStent - CNBC Edwards Lifesciences says FDA has more questions about LifeStent - CNBC
SAN FRANCISCO (Thomson Financial) - Edwards Lifesciences Corp. said Friday it has received additional questions from the Food and Drug Administration regarding its submission for premarket approval of its LifeStent products for a superficial femoral Source: www.cnbc.com FDA panel favors Glaxo, Ligand blood drug - NWITimes.com WASHINGTON - Advisers to the Food and Drug Administration said Friday a blood-clotting drug from GlaxoSmithKline PLC and Ligand Pharmaceuticals Inc. is effective for short-term use, despite reservations by FDA scientists. A panel of 16 outside Source: nwitimes.com New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care
HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. Recalls and Safety Alerts: New Instructions for Using Talecris IG Syringes Talecris Biotherapeutics has revised the directions for administering some of the company's immune globulin products -- ones that come in uncalibrated prefilled 2 mL syringes with fixed needles. The products are HyperRAB? S/D , which is an anti-rabi... 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 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. 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. 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. Solodyn (minocycline HCL) Extended Release Tablets 90 mg Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine). Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health (May 2) Hydrox Labs has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash. Recalls and Safety Alerts: Information on Mortality Rates with the AneuRx� Stent Graft System In a recent Public Health Notification, FDA informed healthcare professionals about new data on mortality rates associated with the AneuRx� Stent Graft System. This endovascular graft, made by Medtronic, is used as an alternative to open surgery in ... 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. Fresca Italia, Inc., Recalls Burrata Because of Possible Health Risk (May 30) Fresca Italia of Brisbane, CA is recalling Burrata 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. New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care
HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care. 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. Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc. FDA Embarks on Major Hiring Initiative for its Public Health Mission The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation. 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. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial 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. 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. FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products. |
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