August 2, 2008Sodium Polystyrene Sulfonate Suspension Sodium Polystyrene Sulfonate Suspension
Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised. FDA 101: Advisory Committees FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees. Warnings on Raw Jalapeño and Serrano Peppers from Mexico Until further notice, FDA is advising consumers to avoid raw serrano peppers from Mexico, in addition to raw jalapeño peppers from Mexico, and any foods that contain them. Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Drug Shortage: Fentanyl transdermal patch Availability information updated. Warning for Regranex—Cream for Leg and Foot Ulcers A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. Beware of Online Cancer Fraud FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice. FDA 101: Biological Products Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Federal Agents Seize more than $24 Million in Unapproved New Drugs Federal Agents Seize more than $24 Million in Unapproved New Drugs
Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical. EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil. Recalls and Safety Alerts: Possible Association between TNF Blockers and Cancer FDA has informed healthcare professionals that it is investigating a possible association between drugs that block tumor necrosis factor (TNF) and the development of lymphoma and other cancers in children and young adults. This is part of FDA's ... FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder The U.S. Food and Drug Administration today approved the first generic version of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches. FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Preventing Medical Errors: Danger Giving Topical Thrombin Intravascularly The Institute for Safe Medication Practices (ISMP) recently warned about the dangers of accidentally giving topical thrombin intravascularly. Thrombin applied topically can help stop oozing blood and minor bleeding from capillaries and small veins. ... FDA Revises Process for Responding to Drug Applications The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). Reuters Health News Summary - San Diego Union-Tribune Reuters Health News Summary - San Diego Union-Tribune
MUNICH, Germany – German doctors have succeeded in transplanting two complete arms onto a 54-year old man in what their hospital said was the world's first operation of this kind. During 15 hours of surgery, a team of 40 medics attached the arms to Source: www.signonsandiego.com FDA rejects Schering-Plough's anesthesia-reversing drug, citing - Newsday WASHINGTON (AP) _ Government regulators dealt a major setback to Schering-Plough Corp., rejecting a highly anticipated drug designed to help patients recover from anesthesia. The Food and Drug Administration notified the company Thursday that it will Source: www.newsday.com FDA finds salmonella strain at second Mexican farm - Waxahachie Daily Light WASINGTON (AP) _ Federal health officials say the salmonella strain linked to a nationwide outbreak has been found in irrigation water and a serrano pepper at a Mexican farm. Dr. David Acheson, the Food and Drug Administration's food safety chief, is Source: www.thedailylight.com FDA says Cadence Pharma drug ready for review - CNN Money NEW YORK (Associated Press) - Shares of Cadence Pharmaceuticals soared Thursday after drug developer said it has completed the major studies necessary to seek U.S. approval for its experimental pain and fever treatment. The Food and Drug Source: money.cnn.com FDA Rejects Schering Drug To Reverse Anesthesia - CBS News (AP) Government regulators dealt a major setback to Schering-Plough Corp., rejecting a highly anticipated drug designed to help patients recover from anesthesia. The Food and Drug Administration notified the company Thursday that it will not approve Source: www.cbsnews.com Senators prod FDA to raise standards on sunscreen - CNBC WASHINGTON - A pair of powerful Democratic senators are prodding the Food and Drug Administration to release tougher standards for sunscreen labels that have been in the works for 30 years. A bill introduced Friday by Sens. Christopher Dodd and Jack Source: www.cnbc.com U.S. probe into salmonella outbreak criticized - San Francisco Gate - Two days of congressional hearings this week into the nation's largest salmonella outbreak in a decade revealed a Keystone Kops government investigation that spanned more than two months and stretched from a false alarm about U.S. tomatoes to Source: www.sfgate.com FDA criticized over its response to salmonella outbreak - Baltimore Sun WASHINGTON - Turf struggles, bad communication and weak leadership undermined the federal response to a recent salmonella outbreak that cost the tomato industry huge losses, witnesses told a House of Representatives subcommittee yesterday. Lawmakers Source: www.baltimoresun.com FDA says may need help from Congress to track food - Forbes WASHINGTON (Reuters) - Congress may need to authorize a better U.S. produce tracking system to improve food safety after the worst foodborne outbreak in a decade, a Food and Drug Administration official said Thursday. Regulators have struggled to Source: www.forbes.com FDA finds salmonella strain at second Mexican farm - New York Daily News FDA finds salmonella strain at second Mexican farm - New York Daily News
The hot peppers were the perps all along. The feds have fingered Serrano peppers from south of the border as "the smoking gun" in the nationwide Salmonella outbreak. The Food and Drug Administration said Wednesday they've pinpointed the root of the Source: www.nydailynews.com Salmonella found in irrigation water at Mexican farm, FDA says - CNN WASHINGTON (CNN) -- A salmonella outbreak in the United States and Canada has been linked to irrigation water and serrano peppers at a Mexican farm, the federal Food and Drug Administration said Wednesday. The salmonella outbreak has been linked to Source: www.cnn.com Senators prod FDA to raise standards on sunscreen - CNBC WASHINGTON - A pair of powerful Democratic senators are prodding the Food and Drug Administration to release tougher standards for sunscreen labels that have been in the works for 30 years. A bill introduced Friday by Sens. Christopher Dodd and Jack Source: www.cnbc.com Anthrax scientist Bruce Ivins stood to benefit from a panic - Los Angeles Times The deadly mailings of anthrax-tainted envelopes transported Ivins from the backwater of government scientific research at Ft. Detrick, Md., to the center of the nation's fledgling war on terrorism. It also spurred multibillion-dollar national Source: www.latimes.com Resolved Drug Shortage: Digoxin oral tablets Resolved Drug Shortage: Digoxin oral tablets
See website for more information about this resolved shortage. Drug Shortage: Fentanyl transdermal patch Availability information updated. Heartworm Prevention in Your Pet Heartworm Prevention in Your Pet
A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program. Warning for Regranex—Cream for Leg and Foot Ulcers A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Prepare for Hurricanes and Floods: Advice From FDA This updated article gives tips on how to keep food, medical products, and pets safe during an emergency. Living with Fibromyalgia, Drugs Approved to Manage Pain A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. FDA Revises Process for Responding to Drug Applications The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. Drug Shortage: Fentanyl transdermal patch Availability information updated. The US Food and Drug Administration To Take On The Tobacco Industry - Eflux Media The US Food and Drug Administration To Take On The Tobacco Industry - Eflux Media
Wednesday was a very important day, or one could even call it a historic day, for the tobacco industry: a law, giving the US Food and Drug Administration authority over regulating cigarettes and any other type of tobacco products, cleared the US Source: www.efluxmedia.com House approves FDA regulation of tobacco - Town Hall House approves FDA regulation of tobacco - Town Hall
WASHINGTON (BP)--The House of Representatives voted convincingly July 30 to give the U.S. Food and Drug Administration authority to regulate tobacco products. Representatives voted 326-102 for the Family Smoking Prevention and Tobacco Control Act, H Source: www.townhall.com House vote treats tobacco for what it is: unhealthy - Detroit Free Press The federal government regulates many things that are inherently less dangerous than tobacco, which may be the only product one uses by sticking it in one's mouth and setting it on fire. The Food and Drug Administration should be able to slap some Source: www.freep.com FDA criticized over its response to salmonella outbreak - Baltimore Sun WASHINGTON - Turf struggles, bad communication and weak leadership undermined the federal response to a recent salmonella outbreak that cost the tomato industry huge losses, witnesses told a House of Representatives subcommittee yesterday. Lawmakers Source: www.baltimoresun.com Amgen's Aranesp and Procrit not appropriate for some cancer patients - Newsday WASHINGTON (AP) _ The Food and Drug Administration on Wednesday ordered changes in the prescribing information for two widely used anemia drugs, saying the risks of the medications outweigh the benefits for certain cancer patients. Anemia is a Source: www.newsday.com Farmers, lawmakers criticize salmonella response - Miami Herald Farmers, lawmakers criticize salmonella response - Miami Herald
WASHINGTON Turf struggles, bad communication and weak leadership undermined the federal response to a recent salmonella outbreak that cost the tomato industry a bundle, witnesses told a House of Representatives subcommittee Thursday. Lawmakers joined Source: www.miamiherald.com The US Food and Drug Administration To Take On The Tobacco Industry - Eflux Media Wednesday was a very important day, or one could even call it a historic day, for the tobacco industry: a law, giving the US Food and Drug Administration authority over regulating cigarettes and any other type of tobacco products, cleared the US Source: www.efluxmedia.com FDA criticized over its response to salmonella outbreak - Baltimore Sun WASHINGTON - Turf struggles, bad communication and weak leadership undermined the federal response to a recent salmonella outbreak that cost the tomato industry huge losses, witnesses told a House of Representatives subcommittee yesterday. Lawmakers Source: www.baltimoresun.com Understanding Food Labels - HealthCentral.com While food shopping, you will no doubt see products labeled as “fat free” or “lite.” What do these labels really mean, and can you trust them? Food manufacturers are required by the Food and Drug Administration (FDA) to meet certain Source: www.healthcentral.com FDA says Cadence Pharma drug ready for review - CNN Money FDA says Cadence Pharma drug ready for review - CNN Money
NEW YORK (Associated Press) - Shares of Cadence Pharmaceuticals soared Thursday after drug developer said it has completed the major studies necessary to seek U.S. approval for its experimental pain and fever treatment. The Food and Drug Source: money.cnn.com Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16) Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16)
The recalled Korica Brand Mut Gung Sweetened Ginger is sold in uncoded 7 oz plastic tubs and is a product of Vietnam. The product was sold nationwide. EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). FDA Extends Consumer Warning on Serrano Peppers from Mexico Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States. Sau-Sea Foods, Inc. Issues Allergy Alert on Undeclared Egg in Smoked Salmon Spread in 7.5 Ounce Plastic Tub With Snap Lid (July 18) Sau-Sea foods, Inc, of Water Mill NY is recalling all tubs of SMOKED SALMON Spread with the sell by dates as follows: 072308, 082708, 092408, 1 12508, 03 1309. People who have an allergy or severe sensitivity to egg run the risk of serious or life threatening allergic reaction if they consume these products. Rize 2 The Occasion Capsules, Rose 4 Her Capsules Rize 2 The Occasion Capsules, Rose 4 Her Capsules
UPDATE - Voluntary nationwide recall of all lot numbers. FDA lab analysis found the products contained a potentially harmful, undeclared ingredient, thiomethisosildenafil. Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Living with Fibromyalgia, Drugs Approved to Manage Pain Living with Fibromyalgia, Drugs Approved to Manage Pain
A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. Warning for Regranex—Cream for Leg and Foot Ulcers A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample The U.S. Food and Drug Administration has cleared for marketing a test that can help health care professionals determine what type of cancer cells are present in a malignant tumor. The Pathwork Tissue of Origin test compares the genetic material of a patient's tumor with genetic information on malignant tumor types stored in a database. Prepare for Hurricanes and Floods: Advice From FDA This updated article gives tips on how to keep food, medical products, and pets safe during an emergency. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Stay Healthy While Traveling Abroad Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. FDA Revises Process for Responding to Drug Applications The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. U.S. Grown Jalape�o and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak The U.S. Food and Drug Administration is advising consumers that jalape�o and serrano peppers grown in the United States are not connected with the current Salmonella Saintpaul outbreak. However, the FDA continues to advise consumers to avoid raw jalape�o peppers--and the food that contains them--if they have been grown, harvested or packed in Mexico. FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals
The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). FDA Consumer Corner: Nonoxynol 9 Contraceptives: No Protection against HIV and Other STDs The Food and Drug Administration wants to be sure that consumers know about new warnings on over-the-counter vaginal contraceptive products that contain the spermicide ingredient nonoxynol 9 (N9). These products include spermicidal gels, foams, film... Amgen's Aranesp and Procrit not appropriate for some cancer patients - Newsday Amgen's Aranesp and Procrit not appropriate for some cancer patients - Newsday
WASHINGTON (AP) _ The Food and Drug Administration on Wednesday ordered changes in the prescribing information for two widely used anemia drugs, saying the risks of the medications outweigh the benefits for certain cancer patients. Anemia is a Source: www.newsday.com House approves FDA regulation of tobacco - Town Hall WASHINGTON (BP)--The House of Representatives voted convincingly July 30 to give the U.S. Food and Drug Administration authority to regulate tobacco products. Representatives voted 326-102 for the Family Smoking Prevention and Tobacco Control Act, H Source: www.townhall.com Understanding Food Labels - HealthCentral.com While food shopping, you will no doubt see products labeled as “fat free” or “lite.” What do these labels really mean, and can you trust them? Food manufacturers are required by the Food and Drug Administration (FDA) to meet certain Source: www.healthcentral.com FDA criticized over its response to salmonella outbreak - Baltimore Sun WASHINGTON - Turf struggles, bad communication and weak leadership undermined the federal response to a recent salmonella outbreak that cost the tomato industry huge losses, witnesses told a House of Representatives subcommittee yesterday. Lawmakers Source: www.baltimoresun.com Heparin taint tied to deaths - Chicago Tribune The U.S. Food and Drug Administration, for the first time, has conclusively linked deaths of patients infused with the blood thinner heparin to a foreign substance found in specific lots of the drug made by Deerfield-based Baxter International Inc Source: www.chicagotribune.com August 1, 2008Is Congress' tobacco regulation decision better late than never? - Detroit Free Press Is Congress' tobacco regulation decision better late than never? - Detroit Free Press
The U.S. House voted Wednesday to give the FDA power to regulate tobacco. All but two of Michigan representatives, Republicans Thad McCotter of Livonia and Tim Walberg of Tipton voted yes. Both of the state’s senators are among co-sponsors of Source: www.freep.com Recalls: Wegmans Sorbet, Viapro supplements - Boston Globe --Perry's Ice Cream is recalling 37,600 cartons of Wegmans Sorbet because the frozen dessert might contain undeclared milk, which could cause a severe or life-threatening reaction in people who have milk allergies. There has been one report of a Source: www.boston.com Salmonella found in irrigation water at Mexican farm, FDA says - CNN WASHINGTON (CNN) -- A salmonella outbreak in the United States and Canada has been linked to irrigation water and serrano peppers at a Mexican farm, the federal Food and Drug Administration said Wednesday. The salmonella outbreak has been linked to Source: www.cnn.com FDA says Salmonella strain found on Mexican farm - Reuters WASHINGTON (Reuters) - U.S. Food and Drug Administration inspectors have found samples of Salmonella bacteria at a farm in Mexico that produces serrano peppers, officials said on Wednesday. They matched the strain that has sickened more than 1,300 Source: www.reuters.com FDA rejects Schering-Plough's anesthesia-reversing drug, citing - Newsday WASHINGTON (AP) _ Government regulators dealt a major setback to Schering-Plough Corp., rejecting a highly anticipated drug designed to help patients recover from anesthesia. The Food and Drug Administration notified the company Thursday that it will Source: www.newsday.com FDA: Salmonella tracked to Mexican farm - USA Today Serrano peppers in a field. Contaminated irrigation water at a farm in Mexico was used on serrano peppers and tomatoes, so it may be the "smoking gun" of the salmonella outbreak that has centered around those foods and jalapenos, the FDA says. April Source: www.usatoday.com FDA finds salmonella strain at second Mexican farm - Houston Chronicle WASHINGTON — The salmonella strain linked to a nationwide outbreak has been found in irrigation water and in a sample from a batch of serrano peppers at a Mexican farm, federal health officials said. Dr. David Acheson, the Food and Drug Source: www.chron.com Congress backs plan for FDA to regulate tobacco - Boston Globe WASHINGTON - The $89- billion-a-year US tobacco industry would be regulated by the Food and Drug Administration for the first time under a measure the House passed yesterday amid threats of a presidential veto. The House voted 326 to 102 for the Source: www.boston.com FDA rejects Schering drug to reverse anesthesia - Forbes Government regulators dealt a major setback to Schering-Plough Corp., rejecting a highly anticipated drug designed to help patients recover from anesthesia. The Food and Drug Administration notified the company Thursday that it will not approve its Source: www.forbes.com Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19)
The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. Federal Agents Seize more than $24 Million in Unapproved New Drugs Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient(July 28) Jack Distribution, LLC, and its wholesale distributors G and N works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of all lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. New lots of Rize 2 and Rose 4 her (not subject to this recall) will contain lot numbers beginning in "BL". Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14) Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). Recalls and Safety Alerts: Possible Association between TNF Blockers and Cancer FDA has informed healthcare professionals that it is investigating a possible association between drugs that block tumor necrosis factor (TNF) and the development of lymphoma and other cancers in children and young adults. This is part of FDA's ... FDA Food Protection Plan Shows Significant Progress The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. FDA Lifts Warning About Eating Certain Types of Tomatoes After a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency is removing its June 7 warning against eating certain types of red raw tomatoes. Sau-Sea Foods, Inc. Issues Allergy Alert on Undeclared Egg in Smoked Salmon Spread in 7.5 Ounce Plastic Tub With Snap Lid (July 18) Sau-Sea foods, Inc, of Water Mill NY is recalling all tubs of SMOKED SALMON Spread with the sell by dates as follows: 072308, 082708, 092408, 1 12508, 03 1309. People who have an allergy or severe sensitivity to egg run the risk of serious or life threatening allergic reaction if they consume these products. Vita Food Products Issues Alert Regarding Vita Nova Salmon (July 25) The product that is the subject of this public announcement and recall are packages (deep dark blue in color) of smoked salmon that bear the Vita logo in the upper left corner on the part of the packaging that is immediately visible to the consumer. Each package contains 4-10 bacon-style slices (total 3 oz.) of smoked salmon; the slices are contained in a vacuum pack within a box that is 4" wide by 7.5" in length by 1/2" in thickness. IMPORTANT: The Code Date of 11/16/08 198 is on the left end flap of each package. This announcement and recall only applies to packages that bear that CODE DATE. FDA rejects Schering drug to reverse anesthesia - Forbes FDA rejects Schering drug to reverse anesthesia - Forbes
Government regulators dealt a major setback to Schering-Plough Corp., rejecting a highly anticipated drug designed to help patients recover from anesthesia. The Food and Drug Administration notified the company Thursday that it will not approve its Source: www.forbes.com Is Congress' tobacco regulation decision better late than never? - Detroit Free Press The U.S. House voted Wednesday to give the FDA power to regulate tobacco. All but two of Michigan representatives, Republicans Thad McCotter of Livonia and Tim Walberg of Tipton voted yes. Both of the state’s senators are among co-sponsors of Source: www.freep.com FDA says Salmonella strain found on a Mexican farm - Reuters WASHINGTON (Reuters) - U.S. Food and Drug Administration inspectors have found samples of Salmonella bacteria at a farm in Mexico that produces serrano peppers, officials said on Wednesday. They matched the strain that has sickened more than 1,300 Source: www.reuters.com FDA rejects Schering-Plough's anesthesia-reversing drug, citing - Newsday WASHINGTON (AP) _ Government regulators dealt a major setback to Schering-Plough Corp., rejecting a highly anticipated drug designed to help patients recover from anesthesia. The Food and Drug Administration notified the company Thursday that it will Source: www.newsday.com Business Highlights - Boston Globe WASHINGTON (AP) -- Unemployment rose last month to its highest rate in four years, adding to the growing body of evidence that an economic recovery is far off. Employers cut 51,000 jobs in July, the Labor Department said Friday. The economy has shed Source: www.boston.com FDA finds salmonella strain on Mexican pepper farm - USA Today Serrano peppers in a field. Contaminated irrigation water at a farm in Mexico was used on serrano peppers and tomatoes, so it may be the "smoking gun" of the salmonella outbreak that has centered around those foods and jalapenos, the FDA says. April Source: www.usatoday.com FDA finds salmonella strain at second Mexican farm - Boston Globe WASHINGTON— The salmonella strain linked to a nationwide outbreak has been found in irrigation water and in a sample from a batch of serrano peppers at a Mexican farm, federal health officials said Wednesday. Dr. David Acheson, the Food and Drug Source: www.boston.com EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient
EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil. FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). Resolved Drug Shortage: Digoxin oral tablets Resolved Drug Shortage: Digoxin oral tablets
See website for more information about this resolved shortage. Sau-Sea Foods, Inc. Issues Allergy Alert on Undeclared Egg in Smoked Salmon Spread in 7.5 Ounce Plastic Tub With Snap Lid (July 18) Sau-Sea Foods, Inc. Issues Allergy Alert on Undeclared Egg in Smoked Salmon Spread in 7.5 Ounce Plastic Tub With Snap Lid (July 18)
Sau-Sea foods, Inc, of Water Mill NY is recalling all tubs of SMOKED SALMON Spread with the sell by dates as follows: 072308, 082708, 092408, 1 12508, 03 1309. People who have an allergy or severe sensitivity to egg run the risk of serious or life threatening allergic reaction if they consume these products. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. FDA Extends Consumer Warning on Serrano Peppers from Mexico Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Nuevo Leon, Mexico, contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). Current Drug Shortage: Proglycem (diazoxide) oral suspension Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Congress backs plan for FDA to regulate tobacco - Boston Globe Congress backs plan for FDA to regulate tobacco - Boston Globe
WASHINGTON - The $89- billion-a-year US tobacco industry would be regulated by the Food and Drug Administration for the first time under a measure the House passed yesterday amid threats of a presidential veto. The House voted 326 to 102 for the Source: www.boston.com FDA unexpectedly rejects Schering anesthesia drug - Reuters NEW YORK (Reuters) - Schering-Plough Corp said (SGP.N: Quote , Profile , Research , Stock Buzz ) on Friday U.S. regulators had rejected Bridion, its drug to reverse the effects of anesthesia that had been heralded as a breakthrough product by Source: www.reuters.com U.S. FDA Issues Action Letter for Sugammadex - MSN MoneyCentral KENILWORTH, N.J. , Aug. 1 /PRNewswire-FirstCall/ -- Schering-Plough Corporation SGP today announced that the U.S. Food and Drug Administration (FDA) has issued a "not-approvable" letter for sugammadex sodium injection for the reversal of muscle Source: news.moneycentral.msn.com PharmaLive: FDA MedWatch- Erythropoiesis Stimulating Agents: Procrit - Phramalive.com ROCKVILLE, MD, Aug. 1, 2008-Amgen and FDA informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Source: www.pharmalive.com FDA rejects Schering drug to reverse anesthesia - Miami Herald WASHINGTON Government regulators dealt a major setback to Schering-Plough Corp., rejecting a highly anticipated drug designed to help patients recover from anesthesia. The Food and Drug Administration notified the company Thursday that it will not Source: www.miamiherald.com Warning for Regranex—Cream for Leg and Foot Ulcers Warning for Regranex—Cream for Leg and Foot Ulcers
A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. FDA Reaches Settlement with California Hearing Device Maker The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law. FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample The U.S. Food and Drug Administration has cleared for marketing a test that can help health care professionals determine what type of cancer cells are present in a malignant tumor. The Pathwork Tissue of Origin test compares the genetic material of a patient's tumor with genetic information on malignant tumor types stored in a database. Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder The U.S. Food and Drug Administration today approved the first generic version of Depakote delayed-release tablets (divalproex sodium). Depakote is approved by the FDA for the treatment of seizures, bipolar disorder and migraine headaches. New Medical Products: New Non-Refrigerated Coagulation Product FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with... Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions FDA Lifts Warning About Eating Certain Types of Tomatoes After a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency is removing its June 7 warning against eating certain types of red raw tomatoes. Abacavir (marketed as Ziagen) and Abacavir-containing Medications Abacavir (marketed as Ziagen) and Abacavir-containing Medications
Association between HLA-B*5701 allele and hypersensitivity reactions identified and patient screening for the allele recommended before starting or restarting treatment. FDA 101: Advisory Committees FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Stay Healthy While Traveling Abroad Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. Sodium Polystyrene Sulfonate Suspension Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised. Making Sense of Vytorin Concerns This article clarifies the results of a study that was published in the New England Journal of Medicine, and emphasizes the importance of continuing on prescribed cholesterol medications. Drug Shortage: MVI Adult Injectable Hospira information updated. Living with Fibromyalgia, Drugs Approved to Manage Pain A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. Mitoxantrone Hydrochloride (marketed as Novantrone and generics) Post-marketing safety study shows poor adherence to cardiac monitoring recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to recommendations for patients with MS. Drug Shortage: MVI Adult Injectable Drug Shortage: MVI Adult Injectable
Hospira information updated. Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18) Matterhorn Group Inc is recalling certain date coded product of their Rainbow Glacier "Astro Pops" water ice frozen novelty pops, Cherry Pineapple Swirl 3.5 oz size 12 count bag pack, with tag closure "Best by JUN 03-09", "Best by JUN 04-09" and "Best by JUN 05-09" sold through the Wal-Mart stores located in California and Arizona, Sunnyside Farms "Missile Pops" Cherry Pineapple in 3.5 oz. size 12 count bag packages, with tag closure of "Best By JUN 02-09", "Best by JUN 03-09", and "Best by JUN 04-09" sold through the California stores of grocery retailers Save Mart and Raley’s, and Vitafreze Frozen Astronot Pops 3.5 oz size 12 count bag packages, with tag closure of "Best By JUN 02-09" sold in California. The products are being recalled because they may contain pieces of hard plastic. Only the noted product date codes listed are affected. Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. Avastin (bevacizumab) Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination. May 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Sodium Polystyrene Sulfonate Suspension Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised. Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. June 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. House vote treats tobacco for what it is: unhealthy - Detroit Free Press House vote treats tobacco for what it is: unhealthy - Detroit Free Press
The federal government regulates many things that are inherently less dangerous than tobacco, which may be the only product one uses by sticking it in one's mouth and setting it on fire. The Food and Drug Administration should be able to slap some Source: www.freep.com House approves FDA regulation of tobacco - Town Hall WASHINGTON (BP)--The House of Representatives voted convincingly July 30 to give the U.S. Food and Drug Administration authority to regulate tobacco products. Representatives voted 326-102 for the Family Smoking Prevention and Tobacco Control Act, H Source: www.townhall.com FDA criticized over its response to salmonella outbreak - Baltimore Sun WASHINGTON - Turf struggles, bad communication and weak leadership undermined the federal response to a recent salmonella outbreak that cost the tomato industry huge losses, witnesses told a House of Representatives subcommittee yesterday. Lawmakers Source: www.baltimoresun.com Preventing Medical Errors: Preventing Fatal Overdoses with Cerebyx Preventing Medical Errors: Preventing Fatal Overdoses with Cerebyx
The Institute for Safe Medication Practices (ISMP) and FDA are warning healthcare professionals that potentially fatal dosing errors continue to occur with the anti-epileptic drug Cerebyx (fosphenytoin), despite clarifications in the drug's labeling ... Electronic Medical Devices Possible malfunction of Electronic Medical Devices caused by Computed Tomography (CT) Scanning on patients with implanted and external electronic medical devices. FDA Food Protection Plan Shows Significant Progress The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. New Medical Products: New Skin Graft Adhesive Approved FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... Recalls and Safety Alerts: FDA Takes Action on Injectable Colchicine FDA is taking action against companies marketing injectable colchicine, which is an unapproved form of the drug. Colchicine is an anti-inflammatory used in the treatment of gout. Colchicine tablets, which are less hazardous, are not affected by FDA... Rize 2 The Occasion Capsules, Rose 4 Her Capsules UPDATE - Voluntary nationwide recall of all lot numbers. FDA lab analysis found the products contained a potentially harmful, undeclared ingredient, thiomethisosildenafil. FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Recalls and Safety Alerts: FDA Studying Heart Attack Risk with Ziagen, Videx 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 the information ... FDA Revises Process for Responding to Drug Applications The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. New Medical Products: New Non-Refrigerated Coagulation Product FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with... Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk (July 9) Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk (July 9)
LUCKY GREEN TRADING, INC. of Garden Grove, CA is recalling Thai Basil , because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). Electronic Medical Devices Possible malfunction of Electronic Medical Devices caused by Computed Tomography (CT) Scanning on patients with implanted and external electronic medical devices. Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product (July 24) At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)
Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. Recalls and Safety Alerts: Update on Potentially Contaminated Heparin Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recomm... June 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Rize 2 The Occasion Capsules, Rose 4 Her Capsules UPDATE - Voluntary nationwide recall of all lot numbers. FDA lab analysis found the products contained a potentially harmful, undeclared ingredient, thiomethisosildenafil. Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31) The manufacturer of Wegmans Sorbet is recalling a limited number of 16 oz. Wegmans brand Sorbets because they may contain undeclared milk. People who have an allergy to milk run the risk of a serious or possible life-threatening allergic reaction if they consume the affected products. Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) FDA clarifies approved conditions for use of ESAs in patients with cancer and revises dosing directions for the products. Sodium Polystyrene Sulfonate Suspension Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient(July 28) Jack Distribution, LLC, and its wholesale distributors G and N works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of all lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. New lots of Rize 2 and Rose 4 her (not subject to this recall) will contain lot numbers beginning in "BL". New Medical Products: New Non-Refrigerated Coagulation Product FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with... FDA Orders Amgen to Change the Labels of Anemia Drug Aranesp FDA Orders Amgen to Change the Labels of Anemia Drug Aranesp
US FDA ordered Amgen Inc on Wednesday to change the labels for Aranesp and similar anemia drugs to address concerns about the risks to cancer patients. The FDA ordered the new labels to say that the drugs shouldn’t be used in cancer patients Source: newscluster.msn.com Lawmakers rip agencies' salmonella investigation - Seattle Times Lawmakers rip agencies' salmonella investigation - Seattle Times
Parker Booth, president of Ace Tomato, displays a tracing code on a box of tomatoes during testimony Thursday on the recent salmonella outbreak. At first, suspicion fell on tomatoes. WASHINGTON — Turf struggles, bad communication and weak Source: seattletimes.nwsource.com House approves FDA regulation of tobacco - Town Hall WASHINGTON (BP)--The House of Representatives voted convincingly July 30 to give the U.S. Food and Drug Administration authority to regulate tobacco products. Representatives voted 326-102 for the Family Smoking Prevention and Tobacco Control Act, H Source: www.townhall.com Is Congress' tobacco regulation decision better late than never? - Detroit Free Press The U.S. House voted Wednesday to give the FDA power to regulate tobacco. All but two of Michigan representatives, Republicans Thad McCotter of Livonia and Tim Walberg of Tipton voted yes. Both of the state’s senators are among co-sponsors of Source: www.freep.com Flawed inquiry hurt tomato growers, congressional panel told - St. Petersburg Times WASHINGTON — Farm officials from Florida and California told a congressional panel Thursday that the investigation into the nation's largest salmonella outbreak was stymied by the FDA's unwillingness to share information, tap industry expertise or Source: www.tampabay.com Japan bans lobster shipments after FDA warning - Canada East PORTLAND, Maine - Shipments of North American lobster, also known as Maine lobster, have been banned by Japan because of a misunderstanding over safety, U.S. officials said Wednesday. News of the stalled shipments of live lobster swept across the New Source: www.canadaeast.com Farmers, lawmakers criticize salmonella response - Miami Herald WASHINGTON Turf struggles, bad communication and weak leadership undermined the federal response to a recent salmonella outbreak that cost the tomato industry a bundle, witnesses told a House of Representatives subcommittee Thursday. Lawmakers joined Source: www.miamiherald.com Agencies grilled on salmonella - Philadelphia Daily News WASHINGTON - The government bungled the salmonella outbreak probe so badly, a House committee chairman said yesterday, that federal investigators reminded him of Keystone Kops. A colleague hoped the maligned tomato can recover its good name. The Source: www.philly.com Evotec Announces Initiation of Phase I Clinical Trial of VR1 - MSN MoneyCentral HAMBURG, Germany, Aug. 1, 2008 (PRIME NEWSWIRE) -- Evotec AG (Nasdaq:EVTC) (Frankfurt:EVT) announced today that dose escalation studies for a Phase I clinical trial of a small molecule VR1 (vanilloid receptor 1) antagonist is being progressed by Source: news.moneycentral.msn.com Farmers, lawmakers criticize salmonella response - Miami Herald Farmers, lawmakers criticize salmonella response - Miami Herald
WASHINGTON Turf struggles, bad communication and weak leadership undermined the federal response to a recent salmonella outbreak that cost the tomato industry a bundle, witnesses told a House of Representatives subcommittee Thursday. Lawmakers joined Source: www.miamiherald.com Man arrested in YouTube baby food poisoning threats - CNN NEW YORK (AP) -- A man was arrested Thursday after he allegedly claimed in hoax Internet videos that he had poisoned millions of bottles of baby food, some with cyanide or rat poison, because he wanted to kill black and Hispanic children. Gerber Source: www.cnn.com Lawmakers rip agencies' salmonella investigation - Seattle Times Parker Booth, president of Ace Tomato, displays a tracing code on a box of tomatoes during testimony Thursday on the recent salmonella outbreak. At first, suspicion fell on tomatoes. WASHINGTON — Turf struggles, bad communication and weak Source: seattletimes.nwsource.com Congress backs plan for FDA to regulate tobacco - Boston Globe WASHINGTON - The $89- billion-a-year US tobacco industry would be regulated by the Food and Drug Administration for the first time under a measure the House passed yesterday amid threats of a presidential veto. The House voted 326 to 102 for the Source: www.boston.com Stay Healthy While Traveling Abroad Stay Healthy While Traveling Abroad
Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. Making Sense of Vytorin Concerns This article clarifies the results of a study that was published in the New England Journal of Medicine, and emphasizes the importance of continuing on prescribed cholesterol medications. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. July 31, 2008Barr Pharma challenges patent on hay fever drug - Boston Globe Barr Pharma challenges patent on hay fever drug - Boston Globe
NEW YORK— Generic drug maker Barr Pharmaceuticals Inc. said Thursday it is challenging a patent supporting 5 mg tablets of the hay fever drug Xyzal. The patent on Xyzal is held by Belgian drug maker UCB Inc. Barr says U.S. sales of the drug totaled Source: www.boston.com The US Food and Drug Administration To Take On The Tobacco Industry - Eflux Media Wednesday was a very important day, or one could even call it a historic day, for the tobacco industry: a law, giving the US Food and Drug Administration authority over regulating cigarettes and any other type of tobacco products, cleared the US Source: www.efluxmedia.com Amgen anemia drug label change has little impact - Boston Globe NEW YORK— Wall Street brushed off concerns over new labeling for Amgen's troubled anemia drugs Thursday, with many analysts saying the changes were expected and will likely have no impact on the biotechnology company's stock. Shares rose 85 cents Source: www.boston.com Amgen's Aranesp and Procrit not appropriate for some cancer patients - Newsday WASHINGTON (AP) _ The Food and Drug Administration on Wednesday ordered changes in the prescribing information for two widely used anemia drugs, saying the risks of the medications outweigh the benefits for certain cancer patients. Anemia is a Source: www.newsday.com Democrats Send Letter To Wyeth Over Controversial Pet Drug - CNN Money WASHINGTON -(Dow Jones)- Leaders of a powerful House committee on Thursday sent a letter to Wyeth (WYE) asking the company to detail why a controversial ingredient in a drug used to treat heartworm in dogs is being tested in humans with river Source: money.cnn.com House approves FDA regulation of tobacco - Town Hall WASHINGTON (BP)--The House of Representatives voted convincingly July 30 to give the U.S. Food and Drug Administration authority to regulate tobacco products. Representatives voted 326-102 for the Family Smoking Prevention and Tobacco Control Act, H Source: www.townhall.com Cadence Pharma surges as drug wraps main studies - Forbes Shares of Cadence Pharmaceuticals soared Thursday after drug developer said it has completed the major studies necessary to seek U.S. approval for its experimental pain and fever treatment. The Food and Drug Administration said Cadence does not have Source: www.forbes.com Heparin taint tied to deaths - Chicago Tribune The U.S. Food and Drug Administration, for the first time, has conclusively linked deaths of patients infused with the blood thinner heparin to a foreign substance found in specific lots of the drug made by Deerfield-based Baxter International Inc Source: www.chicagotribune.com Congress backs plan for FDA to regulate tobacco - Boston Globe Congress backs plan for FDA to regulate tobacco - Boston Globe
WASHINGTON - The $89- billion-a-year US tobacco industry would be regulated by the Food and Drug Administration for the first time under a measure the House passed yesterday amid threats of a presidential veto. The House voted 326 to 102 for the Source: www.boston.com Mexico criticizes US salmonella findings - MSN MoneyCentral MEXICO CITY (AP) - Mexican agriculture officials said Thursday that U.S. colleagues hunting for the source of a salmonella outbreak are rushing to a conclusion about finding the strain at a Mexican pepper farm. The salmonella sample that one U.S Source: moneycentral.msn.com Salmonella probe likened to 'Keystone Kops' - Seattle Times The government bungled the salmonella outbreak probe so badly, a House committee chairman said Thursday, that federal investigators reminded him of Keystone Kops. A colleague hoped the maligned tomato can get its good name back. The House Energy and Source: seattletimes.nwsource.com FDA says Cadence Pharma drug ready for review - MSN MoneyCentral NEW YORK (AP) - Shares of Cadence Pharmaceuticals soared Thursday after drug developer said it has completed the major studies necessary to seek U.S. approval for its experimental pain and fever treatment. The Food and Drug Administration said Source: moneycentral.msn.com FDA advisory panel backs Actemra for moderate to severe rheumatoid - Newsday WASHINGTON (AP) _ A government advisory panel Tuesday recommended approval of the drug Actemra, promoted as a new type of treatment for rheumatoid arthritis, a painful and disabling swelling of the joints generally kept in check with medication. The Source: www.newsday.com FDA Advises Against Consumption Of American Lobster (Maine Lobster - Medical News Today The U.S. Food and Drug Administration warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Source: www.medicalnewstoday.com House Backs FDA Control of Tobacco - Wall Street Journal WASHINGTON -- The House passed a bill giving the Food and Drug Administration authority to regulate tobacco products, bucking White House opposition to the proposed new powers. The bill would give the FDA limited authority to monitor smoking products Source: online.wsj.com Flawed inquiry hurt tomato growers, congressional panel told - St. Petersburg Times WASHINGTON — Farm officials from Florida and California told a congressional panel Thursday that the investigation into the nation's largest salmonella outbreak was stymied by the FDA's unwillingness to share information, tap industry expertise or Source: www.tampabay.com House Presses FDA on Vytorin - Wall Street Journal WASHINGTON -- The House Energy and Commerce Committee wants the Food and Drug Administration to turn over the results of an unpublished analysis looking into the potential links between cancer and the controversial anti-cholesterol drug Vytorin. A Source: online.wsj.com FDA Orders Amgen To Change Label Of Anemia Drug, Aranesp Washington (dbTechno) - The U.S. Food and Drug Administration (FDA) has come out and ordered Amgen Inc. to change the label of their anemia drug, Aranesp. The labels for this particular anemia drug, as well as other similar drugs are going to be Source: newscluster.msn.com FDA finds salmonella strain in irrigation water, serrano pepper at - Daily Press FDA finds salmonella strain in irrigation water, serrano pepper at - Daily Press
WASHINGTON (AP) _ The salmonella strain linked to a nationwide outbreak has been found in irrigation water and in a sample from a batch of serrano peppers at a Mexican farm, federal health officials said. Dr. David Acheson, the Food and Drug Source: www.dailypress.com Salmonella probe likened to 'Keystone Kops' - Seattle Times The government bungled the salmonella outbreak probe so badly, a House committee chairman said Thursday, that federal investigators reminded him of Keystone Kops. A colleague hoped the maligned tomato can get its good name back. The House Energy and Source: seattletimes.nwsource.com Flawed inquiry hurt tomato growers, congressional panel told - St. Petersburg Times WASHINGTON — Farm officials from Florida and California told a congressional panel Thursday that the investigation into the nation's largest salmonella outbreak was stymied by the FDA's unwillingness to share information, tap industry expertise or Source: www.tampabay.com Amgen anemia drug label change has little impact - Boston Globe Amgen anemia drug label change has little impact - Boston Globe
NEW YORK— Wall Street brushed off concerns over new labeling for Amgen's troubled anemia drugs Thursday, with many analysts saying the changes were expected and will likely have no impact on the biotechnology company's stock. Shares rose 85 cents Source: www.boston.com Amgen's Aranesp and Procrit not appropriate for some cancer patients - Newsday WASHINGTON (AP) _ The Food and Drug Administration on Wednesday ordered changes in the prescribing information for two widely used anemia drugs, saying the risks of the medications outweigh the benefits for certain cancer patients. Anemia is a Source: www.newsday.com NY man arrested in baby food poison video threats - Miami Herald NEW YORK A man was arrested Thursday after he allegedly claimed in hoax Internet videos that he had poisoned millions of bottles of baby food, some with cyanide or rat poison, because he wanted to kill black and Hispanic children. Gerber Products Co Source: www.miamiherald.com Democrats Send Letter To Wyeth Over Controversial Pet Drug - CNN Money WASHINGTON -(Dow Jones)- Leaders of a powerful House committee on Thursday sent a letter to Wyeth (WYE) asking the company to detail why a controversial ingredient in a drug used to treat heartworm in dogs is being tested in humans with river Source: money.cnn.com House Passes Historic Bill to Protect Kids from Tobacco; Senator - StreetInsider.com WASHINGTON, July 30 /PRNewswire-USNewswire/ -- The U.S. House of Representatives today took a historic step to save lives by passing legislation that grants the Food and Drug Administration (FDA) authority over tobacco products, including the Source: www.streetinsider.com FDA says may need help from Congress to track food - Forbes WASHINGTON (Reuters) - Congress may need to authorize a better U.S. produce tracking system to improve food safety after the worst foodborne outbreak in a decade, a Food and Drug Administration official said Thursday. Regulators have struggled to Source: www.forbes.com Barr Pharma challenges patent on hay fever drug - Boston Globe NEW YORK— Generic drug maker Barr Pharmaceuticals Inc. said Thursday it is challenging a patent supporting 5 mg tablets of the hay fever drug Xyzal. The patent on Xyzal is held by Belgian drug maker UCB Inc. Barr says U.S. sales of the drug totaled Source: www.boston.com FDA Approves Divalproex Sodium to Treat Epileptic Seizures, Migraine - Eflux Media The U.S. Food and Drug Administration today approved the first generic versions of Depakote delayed-release tablets (divalproex sodium), the agency announced Tuesday. Depakote is approved for the treatment of seizures, bipolar disorder and migraine Source: www.efluxmedia.com Congress backs plan for FDA to regulate tobacco - Boston Globe WASHINGTON - The $89- billion-a-year US tobacco industry would be regulated by the Food and Drug Administration for the first time under a measure the House passed yesterday amid threats of a presidential veto. The House voted 326 to 102 for the Source: www.boston.com Ban on lobsters lifted by Japan - Portland Press Herald Japan has lifted a ban on imports of North American lobster that had been linked to a misunderstanding over safety, industry officials said Wednesday. The ban took effect this week after the Food and Drug Administration warned consumers not to eat Source: news.mainetoday.com FDA Food Protection Plan Shows Significant Progress FDA Food Protection Plan Shows Significant Progress
The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Abacavir (marketed as Ziagen) and Abacavir-containing Medications Association between HLA-B*5701 allele and hypersensitivity reactions identified and patient screening for the allele recommended before starting or restarting treatment. Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. Heartworm Prevention in Your Pet A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program. Herceptin 440 mg Vials and BWFI Diluent Complaints of damaged and broken vials of Herceptin 440 mg and BWFI diluent that may lead to a loss of sterility, which may cause infections in patients. Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions Federal Agents Seize more than $24 Million in Unapproved New Drugs Federal Agents Seize more than $24 Million in Unapproved New Drugs
Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical. House Passes Historic Bill to Protect Kids From Tobacco; Senator - StreetInsider.com House Passes Historic Bill to Protect Kids From Tobacco; Senator - StreetInsider.com
WASHINGTON, July 30 /PRNewswire-USNewswire/ -- The U.S. House of Representatives today took a historic step to save lives by passing legislation that grants the U.S. Food and Drug Administration (FDA) authority over tobacco products, including the Source: www.streetinsider.com Drug Shortage: Fentanyl transdermal patch Drug Shortage: Fentanyl transdermal patch
Availability information updated. Current Drug Shortage: Proglycem (diazoxide) oral suspension Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Sau-Sea Foods, Inc. Issues Allergy Alert on Undeclared Egg in Smoked Salmon Spread in 7.5 Ounce Plastic Tub With Snap Lid (July 18) Sau-Sea foods, Inc, of Water Mill NY is recalling all tubs of SMOKED SALMON Spread with the sell by dates as follows: 072308, 082708, 092408, 1 12508, 03 1309. People who have an allergy or severe sensitivity to egg run the risk of serious or life threatening allergic reaction if they consume these products. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18) Matterhorn Group Inc is recalling certain date coded product of their Rainbow Glacier "Astro Pops" water ice frozen novelty pops, Cherry Pineapple Swirl 3.5 oz size 12 count bag pack, with tag closure "Best by JUN 03-09", "Best by JUN 04-09" and "Best by JUN 05-09" sold through the Wal-Mart stores located in California and Arizona, Sunnyside Farms "Missile Pops" Cherry Pineapple in 3.5 oz. size 12 count bag packages, with tag closure of "Best By JUN 02-09", "Best by JUN 03-09", and "Best by JUN 04-09" sold through the California stores of grocery retailers Save Mart and Raley’s, and Vitafreze Frozen Astronot Pops 3.5 oz size 12 count bag packages, with tag closure of "Best By JUN 02-09" sold in California. The products are being recalled because they may contain pieces of hard plastic. Only the noted product date codes listed are affected. Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product (July 24) At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. FDA 101: Advisory Committees FDA 101: Advisory Committees
FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees. FDA Lifts Warning About Eating Certain Types of Tomatoes After a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency is removing its June 7 warning against eating certain types of red raw tomatoes. Stop and Shop Alerts Customers to Voluntary Recall of Stop and Shop Brand Garlic Bread and Garlic Spread (June 27) The Stop and Shop Supermarket Company has announced a voluntary recall of Stop and Shop brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Stop and Shop removed from its shelves all 16 ounce and 9 ounce packages of Stop and Shop brand garlic bread and all 16 ounce packages of Stop and Shop brand garlic spread products. FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP). Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)
Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. Stronger Warnings Requested for Fluoroquinolones FDA has notified manufacturers of fluoroquinolones that a boxed warning on the increased risk of tendinitis and tendon rupture is necessary. Mitoxantrone Hydrochloride (marketed as Novantrone and generics) Post-marketing safety study shows poor adherence to cardiac monitoring recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to recommendations for patients with MS. Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. New Medical Products: New Non-Refrigerated Coagulation Product FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with... Living with Fibromyalgia, Drugs Approved to Manage Pain A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. Stay Healthy While Traveling Abroad Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. Warning for Regranex—Cream for Leg and Foot Ulcers A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. FDA 101: Biological Products Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. FDA: More Label Warnings for Anemia Drugs - Street.Com FDA: More Label Warnings for Anemia Drugs - Street.Com
The Food and Drug Administration on Wednesday issued anticipated label revisions for anemia drugs such as Amgen's AMGN Aranesp and Johnson & Johnson's JNJ Procrit. Revisions have been expected since a March advisory panel recommended to limit the Source: www.thestreet.com Congress backs plan for FDA to regulate tobacco - Boston Globe WASHINGTON - The $89- billion-a-year US tobacco industry would be regulated by the Food and Drug Administration for the first time under a measure the House passed yesterday amid threats of a presidential veto. The House voted 326 to 102 for the Source: www.boston.com FDA orders safety-related change for anemia drug - Seattle Post Intelligencer WASHINGTON -- The Food and Drug Administration on Wednesday ordered changes in the prescribing information for two widely used anemia drugs, saying the risks of the medications outweigh the benefits for certain cancer patients. Anemia is a frequent Source: seattlepi.nwsource.com FDA says Salmonella strain found on Mexican farm - Reuters UK WASHINGTON (Reuters) - U.S. Food and Drug Administration inspectors have found samples of Salmonella bacteria at a farm in Mexico that produces serrano peppers, officials said on Wednesday. They matched the strain that has sickened more than 1,300 Source: uk.reuters.com July 30, 2008FDA Requests Seizure of Animal Food Products at PETCO Distribution Center FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. Living with Fibromyalgia, Drugs Approved to Manage Pain A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. Beware of Bug Bites and Stings Beware of Bug Bites and Stings
Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions New Medical Products: New Skin Graft Adhesive Approved FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... Warning for Regranex—Cream for Leg and Foot Ulcers A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. Drug Shortage: MVI Adult Injectable Hospira information updated. Making Sense of Vytorin Concerns This article clarifies the results of a study that was published in the New England Journal of Medicine, and emphasizes the importance of continuing on prescribed cholesterol medications. EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient
EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil. Bay Valley Foods Issues Allergy Alert on Undeclared Milk in Mislabeled Kroger Chicken Noodle Soup (June 24) The recalled product, Kroger Chicken Noodle Soup, comes in 10.5 ounce cans and is marked with lot code 52104098, and a "best before" date code of 40910 (April 9, 2010) that can be found on the bottom of the can. Consumers are urged to return the product to the store where it was purchased for a full refund. Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk (July 9) LUCKY GREEN TRADING, INC. of Garden Grove, CA is recalling Thai Basil , because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. Colorado experts find Salmonella in jalapeno - Reuters Colorado experts find Salmonella in jalapeno - Reuters
WASHINGTON (Reuters) - Colorado health officials said they had found a Salmonella-tainted jalapeno in the home of someone sickened in a recent outbreak of the food poisoning -- a vital clue in tracking down the source of the illness. The pepper Source: www.reuters.com FDA warns lobster eaters to avoid the green stuff - Seattle Times FDA warns lobster eaters to avoid the green stuff - Seattle Times
WASHINGTON — The government warned consumers Monday not to eat the soft, green substance found in the body cavity of lobsters, saying it may be contaminated with a toxin. It's still OK to eat the white lobster meat found in the claws and tails of Source: seattletimes.nwsource.com FDA warning on lobsters - WPVI WASHINGTON (AP) - July 29, 2008 (WPVI) -- It's not the most appetizing part of the lobster, and now the government is warning that the soft, green substance in the crustacean's body cavity could be toxic. The Food and Drug Administration says it's Source: abclocal.go.com Salmonella found in irrigation water at Mexican farm, FDA says - CNN WASHINGTON (CNN) -- The salmonella strain linked to the recent outbreak has been found in irrigation water and a serrano pepper at a Mexican farm, a Food and Drug Administration official told lawmakers Wednesday. Raw jalapeño peppers from Mexico Source: sportsillustrated.cnn.com Chugai Pharmaceutical Shares Up After FDA Panel Recommends Actemra - All Headline News Silver Spring, MD (AHN) - Outside medical experts for the Food and Drug Administration (FDA) on Tuesday recommended approval of Roche Holding AG's drug Actemra to treat moderate to severe rheumatoid arthritis. The drug is more effective at reducing Source: www.allheadlinenews.com U.S. Grown Jalape�o and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak U.S. Grown Jalape�o and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak
The U.S. Food and Drug Administration is advising consumers that jalape�o and serrano peppers grown in the United States are not connected with the current Salmonella Saintpaul outbreak. However, the FDA continues to advise consumers to avoid raw jalape�o peppers--and the food that contains them--if they have been grown, harvested or packed in Mexico. Avastin (bevacizumab) Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination. Abacavir (marketed as Ziagen) and Abacavir-containing Medications Association between HLA-B*5701 allele and hypersensitivity reactions identified and patient screening for the allele recommended before starting or restarting treatment. Federal Agents Seize more than $24 Million in Unapproved New Drugs Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical. Recalls and Safety Alerts: FDA Takes Action on Injectable Colchicine FDA is taking action against companies marketing injectable colchicine, which is an unapproved form of the drug. Colchicine is an anti-inflammatory used in the treatment of gout. Colchicine tablets, which are less hazardous, are not affected by FDA... Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. New Medical Products: New Non-Refrigerated Coagulation Product FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with... FDA Advises Against Consumption of American Lobster (Maine Lobster - WebWire FDA Advises Against Consumption of American Lobster (Maine Lobster - WebWire
Regulators find dangerous levels of toxins that cause Paralytic Shellfish Poisoning The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was Source: www.webwire.com Radiology and Children: Extra Care Required Radiology and Children: Extra Care Required
Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Warning for Regranex—Cream for Leg and Foot Ulcers A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. Herceptin 440 mg Vials and BWFI Diluent Complaints of damaged and broken vials of Herceptin 440 mg and BWFI diluent that may lead to a loss of sterility, which may cause infections in patients. FDA 101: Biological Products Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. Prepare for Hurricanes and Floods: Advice From FDA This updated article gives tips on how to keep food, medical products, and pets safe during an emergency. FDA: Don't eat American lobster tomalley - United Press International FDA: Don't eat American lobster tomalley - United Press International
WASHINGTON, July 29 (UPI) -- The U.S. Food and Drug Administration warns consumers not to eat tomalley in American lobster (Maine Lobster), no matter where the lobster was harvested. FDA officials said tomalley -- the green substance found in a Source: www.upi.com Mylan Launches First Generic Version of Antihypertensive Sular(R) ER - MSN MoneyCentral PITTSBURGH , July 28 /PRNewswire-FirstCall/ -- Mylan Inc. MYL today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA Source: news.moneycentral.msn.com June 2008 Monthly Safety Labeling June 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. FDA Lifts Warning About Eating Certain Types of Tomatoes After a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency is removing its June 7 warning against eating certain types of red raw tomatoes. FDA Approves Diaphragm-Pacing Device The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. FDA Food Protection Plan Shows Significant Progress The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. FDA Revises Process for Responding to Drug Applications The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. Recalls and Safety Alerts: FDA Takes Action on Injectable Colchicine FDA is taking action against companies marketing injectable colchicine, which is an unapproved form of the drug. Colchicine is an anti-inflammatory used in the treatment of gout. Colchicine tablets, which are less hazardous, are not affected by FDA... May 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. U.S. Grown Jalape�o and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak The U.S. Food and Drug Administration is advising consumers that jalape�o and serrano peppers grown in the United States are not connected with the current Salmonella Saintpaul outbreak. However, the FDA continues to advise consumers to avoid raw jalape�o peppers--and the food that contains them--if they have been grown, harvested or packed in Mexico. FDA Advises Against Consumption of American Lobster (Maine Lobster) Tomalley The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP). FDA Lifts Warning About Eating Certain Types of Tomatoes FDA Lifts Warning About Eating Certain Types of Tomatoes
After a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency is removing its June 7 warning against eating certain types of red raw tomatoes. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). July 29, 2008New athritis drug gets approval recommendation - Rapid City Journal New athritis drug gets approval recommendation - Rapid City Journal
The Hoffmann-La Roche, Inc. drug is already being used in Japan, and the Food and Drug Administration must now decide whether to give its approval for patients in the United States. Source: www.rapidcityjournal.com Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14) Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14)
Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). Colorado experts find Salmonella in jalapeno - Reuters Colorado experts find Salmonella in jalapeno - Reuters
WASHINGTON (Reuters) - Colorado health officials said they had found a Salmonella-tainted jalapeno in the home of someone sickened in a recent outbreak of the food poisoning -- a vital clue in tracking down the source of the illness. The pepper Source: www.reuters.com New athritis drug gets approval recommendation - Rapid City Journal The Hoffmann-La Roche, Inc. drug is already being used in Japan, and the Food and Drug Administration must now decide whether to give its approval for patients in the United States. Source: www.rapidcityjournal.com Cephalon Beats Profit Targets - Street.Com Cephalon CEPH beat its own and Wall Street's targets for the second quarter and increased guidance for full-year 2008 after the market close Tuesday. Shares of the Frazer, Pa.-based biotech company were down 1% at $71.50 in recent after-hours trading Source: www.thestreet.com New athritis drug gets approval recommendation - Associated Press WASHINGTON (AP) -- A government advisory panel Tuesday recommended approval of the drug Actemra, promoted as a new type of treatment for rheumatoid arthritis, a painful and disabling swelling of the joints generally kept in check with medication. The Source: hosted.ap.org Experimental drug halts Alzheimer's disease in study; one expert calls - Chicago Tribune CHICAGO (AP) _ For the first time, an experimental drug shows promise for halting the progression of Alzheimer's disease by taking a new approach: breaking up the protein tangles that clog victims' brains. The encouraging results from the drug called Source: www.chicagotribune.com Grassley, Dingell Lead Calls For Overhauling FDA - Wall Street Journal WASHINGTON -- Powerful members of Congress want to remake the Food and Drug Administration by giving it broad powers to levy fines, order drug recalls and restrict drug-industry advertising. Leading the drive are Rep. John Dingell (D., Mich.) and his Source: online.wsj.com FDA's Handling of Salmonella Outbreak Riles Some State Officials - Wall Street Journal WASHINGTON -- The federal government's handling of the recent salmonella outbreak has left some state officials angry and frustrated, saying they should have been kept better informed. In Florida, where the Food and Drug Administration sent Source: online.wsj.com Experimental Alzheimer's drug shows early promise - Forbes For the first time, an experimental drug shows promise for halting the progression of Alzheimer's disease by taking a new approach: breaking up the protein tangles that clog victims' brains. The encouraging results from the drug called Rember Source: www.forbes.com FDA Advises Against Consumption of American Lobster (Maine Lobster - WebWire Regulators find dangerous levels of toxins that cause Paralytic Shellfish Poisoning The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was Source: www.webwire.com CompuMed Receives Regulatory Clearance by China's State Food and Drug - Forbes CompuMed, Inc. (OTCBB:CMPD) -- a medical informatics company serving the healthcare community with diagnostic software solutions -- today announced it has received approval from the State Food and Drug Administration (SFDA) of the People's Republic Source: www.forbes.com FDA Advisory Committee Recommends Approval of ACTEMRA(R) (tocilizumab - Forbes FDA Advisory Committee Recommends Approval of ACTEMRA(R) (tocilizumab - Forbes
NUTLEY, N.J., July 29 /PRNewswire/ -- Roche today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) by a near unanimous (10-1) vote recommended approval of ACTEMRA(R) (tocilizumab), a novel interleukin-6 Source: www.forbes.com FDA advisory panel backs Actemra for moderate to severe rheumatoid - Minneapolis Star Tribune WASHINGTON - A government advisory panel Tuesday recommended approval of the drug Actemra, promoted as a new type of treatment for rheumatoid arthritis, a painful and disabling swelling of the joints generally kept in check with medication. The Source: www.startribune.com Tomatoes' bum rap - Herald Tribune Tomatoes' bum rap - Herald Tribune
Florida tomato growers are victims of the federal government's failure to demand an electronic record-keeping system that could more quickly determine the source of food-borne illnesses. HERALD-TRIBUNE ARCHIVE When the Food and Drug Administration Source: www.heraldtribune.com 'Jersey Fresh' means Jersey safe - Atlantic City Press As the Food and Drug Administration lifts the ban on tomatoes grown in certain areas within our country and Mexico, it is time to reflect on the abundance of safe, healthy, nutritious and fresh food within a short distance of our own homes. Many Source: www.pressofatlanticcity.com Vanda shares dive 73% to 90¢ - Baltimore Sun Shares of Vanda Pharmaceuticals fell 73 percent yesterday to its lowest level since going public two years ago after the Rockville company said the U.S. Food and Drug Administration rejected its schizophrenia drug, known as iloperidone. In a letter Source: www.baltimoresun.com Proactive approach to drug safety vital to SFDA approval - expert - Interfax Information Agency China Shanghai. July 29. INTERFAX-CHINA - Pharmaceutical companies should start taking a more proactive approach if they want to better their chances of passing drug safety evaluation, a key step in the process of obtaining a new drug approval from the Source: www.interfax.cn THE JOURNAL OF STEFFANIE RIVERS: The FDA is DOA Part 2 of 2 - EURweb *The Food and Drug Administration wants everyone to believe that jalapeno peppers from Mexico are to blame for the salmonella poisoning of nearly 1,300 people across the United States and Canada. The agency came to that conclusion last week after Source: www.eurweb.com Little monitoring for 'off label' drug ads - MSNBC WASHINGTON - When police pull over a speeding motorist, the officer usually writes out a ticket on the spot. When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven Source: www.msnbc.msn.com For Los Angeles area food police it's slaw and order - Los Angeles Times Executive Chef Jeremy Tummel checks produce delivered to Ciudad restaurant in downtown Los Angeles. In a summer of salmonella scares, chefs are the last line of defense between diners and tainted tomatoes, basil and other produce In a summer of Source: www.latimes.com Current Drug Shortage: Proglycem (diazoxide) oral suspension Current Drug Shortage: Proglycem (diazoxide) oral suspension
Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk (July 9) LUCKY GREEN TRADING, INC. of Garden Grove, CA is recalling Thai Basil , because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Drug Shortage: MVI Adult Injectable Hospira information updated. Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. Stop and Shop Alerts Customers to Voluntary Recall of Stop and Shop Brand Garlic Bread and Garlic Spread (June 27) The Stop and Shop Supermarket Company has announced a voluntary recall of Stop and Shop brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Stop and Shop removed from its shelves all 16 ounce and 9 ounce packages of Stop and Shop brand garlic bread and all 16 ounce packages of Stop and Shop brand garlic spread products. Fluoroquinolone Antimicrobial Drugs BOXED WARNING and Medication Guide to be added to prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use. Current Drug Shortage: Proglycem (diazoxide) oral suspension Current Drug Shortage: Proglycem (diazoxide) oral suspension
Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Recalls and Safety Alerts: Update on Potentially Contaminated Heparin Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recomm... Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion Reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein when used in the cervical spine. New Medical Products: New Skin Graft Adhesive Approved FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
Reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein when used in the cervical spine. Recalls and Safety Alerts: Update on Potentially Contaminated Heparin Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recomm... Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient(July 28) Jack Distribution, LLC, and its wholesale distributors G and N works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of all lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. New lots of Rize 2 and Rose 4 her (not subject to this recall) will contain lot numbers beginning in "BL". Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk (July 21) The recall is a result of sampling by FDA, which revealed that these Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for the current Salmonella outbreak. It is unknown at this time which, if any, of the more than 1,200 illnesses reported to date are related to this particular product or to the grower who supplied this product. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services and the company continue their investigation as to the source of the problem. Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
Reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein when used in the cervical spine. FDA 101: Advisory Committees FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees. Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Stop and Shop Alerts Customers to Voluntary Recall of Stop and Shop Brand Garlic Bread and Garlic Spread (June 27) The Stop and Shop Supermarket Company has announced a voluntary recall of Stop and Shop brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Stop and Shop removed from its shelves all 16 ounce and 9 ounce packages of Stop and Shop brand garlic bread and all 16 ounce packages of Stop and Shop brand garlic spread products. Rize 2 The Occasion Capsules and Rose 4 Her Capsules Certain lots of both products were recalled because they contained an undeclared ingredient. Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14) Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27) Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. FDA Reaches Settlement with California Hearing Device Maker The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law. Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16) The recalled Korica Brand Mut Gung Sweetened Ginger is sold in uncoded 7 oz plastic tubs and is a product of Vietnam. The product was sold nationwide. Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18) Matterhorn Group Inc is recalling certain date coded product of their Rainbow Glacier "Astro Pops" water ice frozen novelty pops, Cherry Pineapple Swirl 3.5 oz size 12 count bag pack, with tag closure "Best by JUN 03-09", "Best by JUN 04-09" and "Best by JUN 05-09" sold through the Wal-Mart stores located in California and Arizona, Sunnyside Farms "Missile Pops" Cherry Pineapple in 3.5 oz. size 12 count bag packages, with tag closure of "Best By JUN 02-09", "Best by JUN 03-09", and "Best by JUN 04-09" sold through the California stores of grocery retailers Save Mart and Raley’s, and Vitafreze Frozen Astronot Pops 3.5 oz size 12 count bag packages, with tag closure of "Best By JUN 02-09" sold in California. The products are being recalled because they may contain pieces of hard plastic. Only the noted product date codes listed are affected. Stop and Shop Alerts Customers to Voluntary Recall of Stop and Shop Brand Garlic Bread and Garlic Spread (June 27) The Stop and Shop Supermarket Company has announced a voluntary recall of Stop and Shop brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Stop and Shop removed from its shelves all 16 ounce and 9 ounce packages of Stop and Shop brand garlic bread and all 16 ounce packages of Stop and Shop brand garlic spread products. Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. Vita Food Products Issues Alert Regarding Vita Nova Salmon (July 25) The product that is the subject of this public announcement and recall are packages (deep dark blue in color) of smoked salmon that bear the Vita logo in the upper left corner on the part of the packaging that is immediately visible to the consumer. Each package contains 4-10 bacon-style slices (total 3 oz.) of smoked salmon; the slices are contained in a vacuum pack within a box that is 4" wide by 7.5" in length by 1/2" in thickness. IMPORTANT: The Code Date of 11/16/08 198 is on the left end flap of each package. This announcement and recall only applies to packages that bear that CODE DATE. FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. Little monitoring for 'off label' drug ads - MSNBC Little monitoring for 'off label' drug ads - MSNBC
WASHINGTON - When police pull over a speeding motorist, the officer usually writes out a ticket on the spot. When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven Source: www.msnbc.msn.com For Los Angeles area food police it's slaw and order - Los Angeles Times Executive Chef Jeremy Tummel checks produce delivered to Ciudad restaurant in downtown Los Angeles. In a summer of salmonella scares, chefs are the last line of defense between diners and tainted tomatoes, basil and other produce In a summer of Source: www.latimes.com 'Jersey Fresh' means Jersey safe - Atlantic City Press As the Food and Drug Administration lifts the ban on tomatoes grown in certain areas within our country and Mexico, it is time to reflect on the abundance of safe, healthy, nutritious and fresh food within a short distance of our own homes. Many Source: www.pressofatlanticcity.com UPDATE 1-Teva's Q2 profit rises, beats expectations - Reuters July 29 (Reuters) - Teva Pharmaceutical Industries Ltd (TEVA.O: Quote , Profile , Research , Stock Buzz ) (TEVA.TA: Quote , Profile , Research , Stock Buzz ), the world's largest generic drugmaker, said on Tuesday its second-quarter profit rose Source: www.reuters.com Tomatoes' bum rap - Herald Tribune Florida tomato growers are victims of the federal government's failure to demand an electronic record-keeping system that could more quickly determine the source of food-borne illnesses. HERALD-TRIBUNE ARCHIVE When the Food and Drug Administration Source: www.heraldtribune.com Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23)
Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. Vita Food Products Issues Alert Regarding Vita Nova Salmon (July 25) The product that is the subject of this public announcement and recall are packages (deep dark blue in color) of smoked salmon that bear the Vita logo in the upper left corner on the part of the packaging that is immediately visible to the consumer. Each package contains 4-10 bacon-style slices (total 3 oz.) of smoked salmon; the slices are contained in a vacuum pack within a box that is 4" wide by 7.5" in length by 1/2" in thickness. IMPORTANT: The Code Date of 11/16/08 198 is on the left end flap of each package. This announcement and recall only applies to packages that bear that CODE DATE. July 28, 2008Avastin (bevacizumab) Avastin (bevacizumab)
Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination. FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. FDA Reaches Settlement with California Hearing Device Maker The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. FDA Approves Diaphragm-Pacing Device The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. U.S. Grown Jalape�o and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak The U.S. Food and Drug Administration is advising consumers that jalape�o and serrano peppers grown in the United States are not connected with the current Salmonella Saintpaul outbreak. However, the FDA continues to advise consumers to avoid raw jalape�o peppers--and the food that contains them--if they have been grown, harvested or packed in Mexico. FDA Revises Process for Responding to Drug Applications The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19)
The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. Abacavir (marketed as Ziagen) and Abacavir-containing Medications Association between HLA-B*5701 allele and hypersensitivity reactions identified and patient screening for the allele recommended before starting or restarting treatment. In Furtherance of Productive Discussions with FDA, IRIS to Proceed - Earthtimes In Furtherance of Productive Discussions with FDA, IRIS to Proceed - Earthtimes
CHATSWORTH, Calif. - (Business Wire) IRIS INTERNATIONAL, INC. (NASDAQ: IRIS) , after extensive consultation with the US Food and Drug Administration (FDA), intends to resubmit its 510(k) for its NADiA ™ PSA (Prostate Specific Antigen) ultra Source: www.earthtimes.org FDA faulted over unapproved uses of medications - AOL WASHINGTON -When a state trooper pulls over a speeding motorist, the officer usually writes out a ticket on the spot. When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of Source: news.aol.com FDA: Don't Eat Maine Lobster Tomalley - WebMD July 28, 2008 -- The FDA today warned consumers to avoid eating tomalley in American lobster (also called Maine lobster) because of a potential contamination of dangerous levels of toxins that can cause paralytic shellfish poisoning, which can be Source: www.webmd.com FDA Regulation of Tobacco — Pitfalls and Possibilities - New England Journal of Medicine After more than half a century of debate and discussion, it is likely that during the coming year, Congress will pass legislation bringing tobacco products under the regulatory authority of the Food and Drug Administration (FDA). The regulatory Source: content.nejm.org FDA Warns Against Eating Lobster Liver - CBS News (AP) The government warned consumers Monday not to eat the soft, green substance found in the body cavity of lobsters, saying it may be contaminated with a toxin. It's still OK to eat the white lobster meat found in the claws and tails of the Source: www.cbsnews.com FDA rejects Vanda Pharmaceuticals drug, sending stock plunging - Washington Business Journal Shares of Rockville-based Vanda Pharmaceuticals Inc. sunk to an all-time low on Monday after the company announced that its lead drug candidate had been rejected by the Food and Drug Administration. Regulators said Vanda’s schizophrenia drug Source: washington.bizjournals.com FDA says no to Titan's schizophrenia drug - MSN MoneyCentral The Food and Drug Administration rejected an application for the drug iloperidone, meant as a treatment for schizophrenia. Titan Pharmaceuticals Inc., which owns rights to the drug, licensed it to Vanda Pharmaceuticals Inc. (NASDAQ: VNDA), which Source: news.moneycentral.msn.com CV angina drug action delayed by FDA - MSN MoneyCentral Cardiovascular drug maker CV Therapeutics Inc. of Palo Alto said the Food and Drug Administration pushed its review of the angina drug Ranexa beyond Sunday. That was the day the FDA was to give its approval or not for expanding the use of Ranexa as a Source: news.moneycentral.msn.com FDA rejects Vanda Pharmaceuticals drug - Baltimore Business Journal KC-area auto plants should swerve past industry's wreckage [Kansas City] Sourcefire adds severance pay to retain key executives [Baltimore] For AK Steel, demand, stock riding high [Cincinnati] Xanodyne's Zipsor on track for FDA approval [Cincinnati Source: baltimore.bizjournals.com FDA Issues Not Approvable Letter for Iloperidone to Vanda - MSN MoneyCentral FDA Issues Not Approvable Letter for Iloperidone to Vanda - MSN MoneyCentral
Titan Pharmaceuticals, Inc. TTP today announced that Vanda Pharmaceuticals, Inc. VNDA has received a not approvable letter for iloperidone, an investigational atypical antipsychotic for the treatment of schizophrenia, from the U.S. Food and Drug Source: news.moneycentral.msn.com Vanda schizophrenia drug rejected by FDA - BusinessWeek Vanda Pharmaceuticals Inc. said Monday the Food and Drug Administration rejected the biotechnology company's experimental schizophrenia drug iloperidone, saying it was similar to drugs already on the market. Shares of Vanda lost about half their Source: www.businessweek.com Prescription Drugs | FDA Poorly Equipped To Enforce Off-Label - Kaisernetwork.org FDA takes an average of seven months to issue warnings to pharmaceutical companies that market medications for off-label uses, and those companies take an average of four months to address the violations, according to a draft report compiled by the Source: www.kaisernetwork.org Vanda Pharmaceuticals Announces Receipt of Not Approvable Letter From - MSN MoneyCentral ROCKVILLE, Md. , July 28 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. VNDA announced today the receipt of a not approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application for iloperidone, an Source: news.moneycentral.msn.com Vanda Pharma Sinks on FDA Rejection - Street.Com Vanda Pharmaceuticals VNDA said Monday that the Food and Drug Administration rejected its lead drug, iloperidone, and will require another clinical trial and more safety data before it can approve the antipsychotic drug. Shares plummeted $2.11, or 62 Source: www.thestreet.com UPDATE 1-Vanda gets FDA not-approvable letter on iloperidone - Reuters July 28 (Reuters) - Vanda Phamaceuticals Inc (VNDA.O: Quote , Profile , Research , Stock Buzz ), received a not approvable letter from U.S. regulatory authorities for its treatment of schizophrenia, sending its shares tumbling before the opening bell Source: www.reuters.com FDA Says It Is Safe To Eat Jalapeno Peppers Grown In U.S. - dbtechno.com Boston (dbTechno) - The U.S. Food and Drug Administration (FDA) has come out and stated that jalapeno and serrano peppers grown in the United States are safe to eat, and are not linked in any way to the salmonella outbreak. The FDA has clarified Source: www.dbtechno.com Ikaria(R) Receives FDA Orphan Drug Designation for Inhaled Carbon - Forbes CLINTON, N.J., July 28 /PRNewswire/ -- Ikaria Holdings, Inc., a fully integrated critical care biotherapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for inhaled carbon monoxide Source: www.forbes.com Vanda shares plunge on FDA drug rejection - Forbes Shares of Vanda Pharmaceuticals Inc. dove to their lowest point in more than two years Monday after the Food and Drug Administration rejected the company's experimental schizophrenia treatment, prompting the drug developer to put the program on hold Source: www.forbes.com Trans fats banned in California restaurant food - Christian Today Trans fats banned in California restaurant food - Christian Today
Gov. Arnold Schwarzenegger signed legislation on Friday making California the first U.S. state to prohibit restaurants from preparing food with trans fats, which clog arteries and raise the risk of heart disease. The bill will be phased in starting Source: www.christiantoday.com Drive against sale of substandard food items starts - Nation ISLAMABAD - The Islamabad Capital Territory administration has launched a special drive against the sale of substandard food items and spurious medicines. In this regard, District Health Officer Dr Amir Zada Khan and drug inspector Sardar Shabbir Source: www.nation.com.pk Share this story: - Daily Chronicle WASHINGTON - When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven months to issue a warning, according to a draft report by congressional investigators. It typically Source: www.daily-chronicle.com Delray clinic a leader in Alzheimer's research - Palm Beach Post But by now, if she hadn't been given a new drug from pharmaceutical giants Wyeth and Elan Corp., she probably wouldn't be laughing. She'd be struggling to bathe and dress herself. Friedman, 82, of Hollywood has been taking bapineuzumab since 2006 Source: www.palmbeachpost.com Vanda Pharmaceutical gets not approval letter from FDA for - Forbes Vanda Pharmaceutical gets not approval letter from FDA for - Forbes
NEW YORK (Thomson Financial) - Vanda Pharmaceuticals Inc. Monday said it was putting all activities related to its drug iloperidone on hold after receiving a not approvable letter from the Food and Drug Administration for the drug's New Drug Source: www.forbes.com Prescription Drugs | FDA Poorly Equipped To Enforce Off-Label - Kaisernetwork.org FDA takes an average of seven months to issue warnings to pharmaceutical companies that market medications for off-label uses, and those companies take an average of four months to address the violations, according to a draft report compiled by the Source: www.kaisernetwork.org Drug ad rules are hazy, enforcement often slow, GAO reports - Baltimore Sun Drug ad rules are hazy, enforcement often slow, GAO reports - Baltimore Sun
WASHINGTON - When a state trooper pulls over a speeding motorist, the officer usually writes out a ticket on the spot. When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of Source: www.baltimoresun.com Vanda Pharmaceutical gets not approval letter from FDA for - Forbes NEW YORK (Thomson Financial) - Vanda Pharmaceuticals Inc. Monday said it was putting all activities related to its drug iloperidone on hold after receiving a not approvable letter from the Food and Drug Administration for the drug's New Drug Source: www.forbes.com Herceptin 440 mg Vials and BWFI Diluent Herceptin 440 mg Vials and BWFI Diluent
Complaints of damaged and broken vials of Herceptin 440 mg and BWFI diluent that may lead to a loss of sterility, which may cause infections in patients. Salmolux Inc. Recalls Wild Alaskan Smoked Salmon Nova Lox Lot # 01418 Because of Possible Health Risk (July 9) Salmolux Inc. of Federal Way, WA, is recalling lot # 01418 of its Wild Alaskan Smoked Salmon Nova Lox sold in 3 ounce packages due to the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Sau-Sea Foods, Inc. Issues Allergy Alert on Undeclared Egg in Smoked Salmon Spread in 7.5 Ounce Plastic Tub With Snap Lid (July 18) Sau-Sea foods, Inc, of Water Mill NY is recalling all tubs of SMOKED SALMON Spread with the sell by dates as follows: 072308, 082708, 092408, 1 12508, 03 1309. People who have an allergy or severe sensitivity to egg run the risk of serious or life threatening allergic reaction if they consume these products. Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion Reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein when used in the cervical spine. Abacavir (marketed as Ziagen) and Abacavir-containing Medications Association between HLA-B*5701 allele and hypersensitivity reactions identified and patient screening for the allele recommended before starting or restarting treatment. Rize 2 The Occasion Capsules and Rose 4 Her Capsules Certain lots of both products were recalled because they contained an undeclared ingredient. Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17) Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico (July 14) Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). Rize 2 The Occasion Capsules and Rose 4 Her Capsules Rize 2 The Occasion Capsules and Rose 4 Her Capsules
Certain lots of both products were recalled because they contained an undeclared ingredient. Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. Stay Healthy While Traveling Abroad Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. Living with Fibromyalgia, Drugs Approved to Manage Pain A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints. FDA Food Protection Plan Shows Significant Progress FDA Food Protection Plan Shows Significant Progress
The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. FDA Revises Process for Responding to Drug Applications The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. FDA Reaches Settlement with California Hearing Device Maker The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law. Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. July 27, 2008FDA Approves First Generic Risperidone to Treat Psychiatric Conditions FDA Approves First Generic Risperidone to Treat Psychiatric Conditions
The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions. FDA 101: Biological Products Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. FDA Approves Diaphragm-Pacing Device The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. FDA 101: Advisory Committees FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees. Heartworm Prevention in Your Pet A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program. U.S. Grown Jalape�o and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak The U.S. Food and Drug Administration is advising consumers that jalape�o and serrano peppers grown in the United States are not connected with the current Salmonella Saintpaul outbreak. However, the FDA continues to advise consumers to avoid raw jalape�o peppers--and the food that contains them--if they have been grown, harvested or packed in Mexico. FDA Approves New Genetic Test for Patients with Breast Cancer The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18) Matterhorn Group Inc. Announces Voluntary Recall of Astro Pops and Missile Pops 3.5 oz Cherry Pineapple Frozen Novelty Pops in Arizona, Nevada and California due to Safety Hazard (June 18)
Matterhorn Group Inc is recalling certain date coded product of their Rainbow Glacier "Astro Pops" water ice frozen novelty pops, Cherry Pineapple Swirl 3.5 oz size 12 count bag pack, with tag closure "Best by JUN 03-09", "Best by JUN 04-09" and "Best by JUN 05-09" sold through the Wal-Mart stores located in California and Arizona, Sunnyside Farms "Missile Pops" Cherry Pineapple in 3.5 oz. size 12 count bag packages, with tag closure of "Best By JUN 02-09", "Best by JUN 03-09", and "Best by JUN 04-09" sold through the California stores of grocery retailers Save Mart and Raley’s, and Vitafreze Frozen Astronot Pops 3.5 oz size 12 count bag packages, with tag closure of "Best By JUN 02-09" sold in California. The products are being recalled because they may contain pieces of hard plastic. Only the noted product date codes listed are affected. ETHEX Corporation Voluntarily Recalls Specific Lots of 30 mg. and 60 mg. Morphine Sulfate Extended Release Tablets Due to the Potential for Oversized Tablets (June 13) ETHEX Corporation announced today that it has voluntarily recalled specific additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between June 2006 and May 2008. Stay Healthy While Traveling Abroad Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product (July 24) At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. Publix Issues Recall for No Sugar Added Cherry Pie (July 24) Publix Super Markets is issuing a voluntary recall on three codes of No Sugar Added Cherry Pie with a sell-by-date of July 8 – July 27. UPC numbers for the affected product may be found on the back label below the Nutritional Facts panel: Publix NSA 8inch Cherry Pie, UPC: 41415-65990; Publix NSA 1/2 Cherry Pie, UPC: 03000-00225; and Publix NSA 1/4 Cherry Pie, UPC: 41415-66990. Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. Beware of Online Cancer Fraud FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice. Prepare for Hurricanes and Floods: Advice From FDA This updated article gives tips on how to keep food, medical products, and pets safe during an emergency. Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Trans fats banned in California restaurant food - Christian Today Trans fats banned in California restaurant food - Christian Today
Gov. Arnold Schwarzenegger signed legislation on Friday making California the first U.S. state to prohibit restaurants from preparing food with trans fats, which clog arteries and raise the risk of heart disease. The bill will be phased in starting Source: www.christiantoday.com Share this story: - Daily Chronicle WASHINGTON - When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven months to issue a warning, according to a draft report by congressional investigators. It typically Source: www.daily-chronicle.com Delray clinic a leader in Alzheimer's research - Palm Beach Post But by now, if she hadn't been given a new drug from pharmaceutical giants Wyeth and Elan Corp., she probably wouldn't be laughing. She'd be struggling to bathe and dress herself. Friedman, 82, of Hollywood has been taking bapineuzumab since 2006 Source: www.palmbeachpost.com Food industry bitten by its lobbying success - Pantagraph WASHINGTON, D.C. -- The food industry must drop any remaining opposition to electronic record-keeping and back an effective system for tracing contaminated food to its source, a lawmaker investigating food safety said Friday. "It is my hope that the Source: www.pantagraph.com FDA: Avoid jalapenos from Mexico, not US - Waxahachie Daily Light WASHINGTON (AP) _ Only jalapeno peppers grown in Mexico are implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. The Food and Drug Administration urged consumers to avoid raw Mexican jalapenos Source: www.thedailylight.com Drive against sale of substandard food items starts - Nation ISLAMABAD - The Islamabad Capital Territory administration has launched a special drive against the sale of substandard food items and spurious medicines. In this regard, District Health Officer Dr Amir Zada Khan and drug inspector Sardar Shabbir Source: www.nation.com.pk Little monitoring for 'off label' drug ads - MSNBC WASHINGTON - When police pull over a speeding motorist, the officer usually writes out a ticket on the spot. When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven Source: www.msnbc.msn.com Health Officials Limit Salmonella Warning To Mexico-Grown Peppers - Eflux Media Health Officials Limit Salmonella Warning To Mexico-Grown Peppers - Eflux Media
U.S. health officials are on the right track of solving the salmonella outbreak mystery and have issued on Friday a recommendation for consumers to avoid only raw jalapeno peppers from Mexico , limiting a previous warning against eating any uncooked Source: www.efluxmedia.com Food safety laws under scrutiny - Miami Herald This summer's salmonella outbreak could go down as the national food supply's biggest unsolved mystery. Instead of a smoking gun, the only clue is a single tainted jalapeño pepper with the rare strain of Salmonella Saintpaul found at a Texas produce Source: www.miamiherald.com FDA faulted over unapproved uses of medications - Forbes FDA faulted over unapproved uses of medications - Forbes
When a state trooper pulls over a speeding motorist, the officer usually writes out a ticket on the spot. When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven months Source: www.forbes.com Report faults FDA over unapproved drug uses - USA Today WASHINGTON (AP) — When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven months to issue a warning, according to a draft report by congressional investigators. It Source: www.usatoday.com FDA says to avoid jalapenos from Mexico, not the U.S. - Fort Lauderdale Sun-Sentinel WASHINGTON - Only jalapeno peppers grown in Mexico are implicated in the nationwide salmonella outbreak, the government announced Friday in clearing the U.S. crop. The Food and Drug Administration urged consumers to avoid raw Mexican jalapenos and Source: www.sun-sentinel.com Drug Shortage: MVI Adult Injectable Drug Shortage: MVI Adult Injectable
Hospira information updated. Current Drug Shortage: Proglycem (diazoxide) oral suspension Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 FDA 101: Biological Products Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. Are You Storing Food Safely? When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards. Recalls and Safety Alerts: Update on Potentially Contaminated Heparin Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recomm... Drug Shortage: MVI Adult Injectable Drug Shortage: MVI Adult Injectable
Hospira information updated. Pet Food Products Seized at PETCO Distribution Center Consumers who bought animal food products from PETCO in 16 states should take certain precautions Stay Healthy While Traveling Abroad Stay Healthy While Traveling Abroad
Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16) The recalled Korica Brand Mut Gung Sweetened Ginger is sold in uncoded 7 oz plastic tubs and is a product of Vietnam. The product was sold nationwide. Stop and Shop Alerts Customers to Voluntary Recall of Stop and Shop Brand Garlic Bread and Garlic Spread (June 27) The Stop and Shop Supermarket Company has announced a voluntary recall of Stop and Shop brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Stop and Shop removed from its shelves all 16 ounce and 9 ounce packages of Stop and Shop brand garlic bread and all 16 ounce packages of Stop and Shop brand garlic spread products. Sodium Polystyrene Sulfonate Suspension Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. Rize 2 The Occasion Capsules and Rose 4 Her Capsules Certain lots of both products were recalled because they contained an undeclared ingredient. Food industry bitten by its lobbying success - Forbes Food industry bitten by its lobbying success - Forbes
One of the worst outbreaks of foodborne illness in the U.S. is teaching the food industry the truth of the adage, "Be careful what you wish for because you might get it." The industry pressured the Bush administration years ago to limit the paperwork Source: www.forbes.com Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16) Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger (July 16)
The recalled Korica Brand Mut Gung Sweetened Ginger is sold in uncoded 7 oz plastic tubs and is a product of Vietnam. The product was sold nationwide. Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk (July 19) The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY. The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label. Salmolux Inc. Recalls Wild Alaskan Smoked Salmon Nova Lox Lot # 01418 Because of Possible Health Risk (July 9) Salmolux Inc. of Federal Way, WA, is recalling lot # 01418 of its Wild Alaskan Smoked Salmon Nova Lox sold in 3 ounce packages due to the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27) Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product (July 24) At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. Sau-Sea Foods, Inc. Issues Allergy Alert on Undeclared Egg in Smoked Salmon Spread in 7.5 Ounce Plastic Tub With Snap Lid (July 18) Sau-Sea foods, Inc, of Water Mill NY is recalling all tubs of SMOKED SALMON Spread with the sell by dates as follows: 072308, 082708, 092408, 1 12508, 03 1309. People who have an allergy or severe sensitivity to egg run the risk of serious or life threatening allergic reaction if they consume these products. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. |
Subscribe to Posts [Atom]