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- FDA Alerts
- Recalls (Drug & Food)
Dec 17, 2014 - Bleating Heart Cheese (BHC) is conducting a voluntary recall of a few of its sheep milk and cow’s milk cheese produced in late May, late June and early July of 2014, based on sampling by the US Food & Drug Administration (FDA) that found the presence of Listeria monocytogenes in at least one sample of the following cheeses. At this time, no illnesses have been reported, but to reduce possible health risks and ensure that all suspect product is removed from the marketplace, BHC is initiating this voluntary recall in cooperation with the California Departments of Food & Agriculture and Public Health.Dec 17, 2014 - Tristar Equine Marketing, LLC is voluntarily recalling all lots of Gastrotec down to the consumer level. Gastrotec was previously marketed by Tristar as an OTC drug for use in horses, and contains a combination of Omeprazole and Misoprostol.Baxter Voluntarily Initiates U.S. Recall of Two Lots of Sodium Chloride Injection, USP Due to the P...Dec 15, 2014 - Baxter International Inc. announced today it voluntarily initiated a recall in the United States of two lots of 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container to the hospital/user level. The recall is being initiated as a result of two complaints (one per lot) of particulate matter that was identified as a fragment of the frangible from the vial adapter.Dec 15, 2014 - Flat Creek Farm & Dairy of Swainsboro, GA has recalled 3 lots of cheese with lot codes 140802XAZ (Aztec Cheddar), 140702XAZ (Low Country Gouda voluntary recall) and 140725XGO (Aztec Cheddar voluntary recall) because of potential to be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.Dec 12, 2014 - Giant Eagle has issued a recall of Giant Eagle Apple Pistachio Salad and Apple Pistachio Salad with Chicken because the salads may contain fresh cut Gala red apples currently recalled by Del Monte Fresh Produce N.A. due to potential Listeria monocytogenes contamination. To date, Giant Eagle has received no reports of customer illnesses associated with this recall.Whalens Horseradish Products, Inc. Issues Allergy Alert on Undeclared Anchovy in Whalens Seafood & ...Dec 10, 2014 - Whalen’s Horseradish Products, Inc. of Galway, NY is recalling WHALEN’S SEAFOOD & BURGER SAUCE, because it contains undeclared anchovy, an element of the Worcestershire Sauce used in the finished product. People who have an allergy to fish run the risk of a serious or life-threatening allergic reaction if they consume this product.Del Monte Fresh Produce N.A., Inc. Voluntarily Recalls Fresh Cut Fruit Containing Gala Red Apple in...Dec 10, 2014 - Del Monte Fresh Produce N.A., Inc. (“Del Monte Fresh”) announced today the voluntary recall of fresh cut fruit containing Gala red apples grown in Pennsylvania. The affected product was distributed to a limited number of customers in a few States in North East US and is being recalled because these apples have the potential to be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.Global Garlic Inc. Recalls De Mi Pais Products Cuajada Fresca (Fresh Curd) and Cuajada Olanchana (F...Dec 9, 2014 - Global Garlic, Inc. of Miami, FL is recalling De Mi Pais products: Cuajada Fresca (Fresh Curd) 12oz. and Cuajada Olanchana (Fresh Curd) 12oz., because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.Alere Initiates Voluntary URGENT CORRECTION for Use of Alere INRatio and INRatio2 PT/INR Monitor Sy...Dec 8, 2014 - Alere Inc. (NYSE:ALR) has initiated a voluntary correction to inform U.S. users of the Alere INRatio and INRatio2 PT/INR Monitor system of certain medical conditions that should not be tested with the system (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips). In certain cases an INRatio and INRatio2 PT/INR Monitor system may provide an INR result that is clinically significantly lower than a result obtained using a reference INR system (laboratory method).Safeway Recalls Safeway Select French Salted Caramel (Fleur De Sel) Premium Ice Cream Sold November...Dec 6, 2014 - Safeway is voluntarily recalling Safeway Select French Salted Caramel (Fleur De Sel) Premium Ice Cream sold in all Safeway-owned stores from November 4, 2014 through December 5, 2014 due to the inclusion of an undeclared peanut allergen.House of Flavors Issues Voluntary Recall Due to Possible Undeclared Dairy Allergen in Ciao Bella Da...Dec 5, 2014 - House of Flavors, Inc., based in Ludington, Michigan, is recalling Ciao Bella Dark Cocoa Sorbetto manufactured by House of Flavors because it’s ingredients may include an undeclared dairy allergen. Consumers who may have an allergy or severe sensitivity to dairy run the risk of serious or life-threatening allergic reaction if they consume this product.Dec 4, 2014 - Abdallah Candies of Burnsville, MN is taking precautionary measures and voluntarily recalling red and silver foil wrapped Holiday Caramel Bites. One customer has reported finding a peanut butter bite, wrapped in red foil, in a bag of holiday caramel bites.Dec 4, 2014 - Lakeland Animal Nutrition has been informed that certain horse feeds manufactured by the company in Lakeland, Florida and distributed within the state of Florida may contain monensin and lasalocid. Serious injury or death can occur in horses consuming feeds containing monensin and/or lasalocid.Overhill Farms Voluntarily Recalls Open Nature Chile Cheese Enchiladas Sold At Safeway Stores Natio...Dec 3, 2014 - Overhill Farms, Inc. of Vernon, California is voluntarily recalling the frozen food product Open Nature Chile Cheese Enchiladas due to potential Salmonella contamination.Dec 3, 2014 - Heart Sync Inc. announces that it has notified customers of a Voluntary Urgent Device Correction for certain Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillator Units.Whole Foods Market West Hartford, Bishops Corner and Glastonbury Recall Tarte Aux Pommes Due to Und...Dec 1, 2014 - Three Connecticut Whole Foods Market locations are recalling “Tarte Aux Pommes” produced and sold in West Hartford Center, Bishops Corner and Glastonbury, Connecticut due to an undeclared almonds. The 6 inch tarte was mislabeled as a “Tarte Aux Pomme 10in” and has a “best by” date between November 20 and December 1, 2014. The six inch tarte contained almonds as an ingredient, which was not declared on the label.Nov 26, 2014 - Whole Foods Market is recalling “Vegan pumpkin pie” produced and sold in the Southwest Region, which includes TX, OK, LA, AR, due to undeclared walnuts.Select Containers of Private Selection Denali Extreme Moose Tracks Ice Cream Recalled for Undeclare...Nov 26, 2014 - The Kroger Co. (NYSE: KR) said today it is recalling select containers of Private Selection Denali Extreme Moose Tracks Ice Cream sold in 13 states because it may contain peanuts not listed on the label. Item Description: Private Selection Denali Extreme Moose Tracks Ice Cream sold in 48-ounce containers with a "sell by" date of April 16, 2015 under the following UPC Code: 11110-00456.CONMED Corporation Issues a Voluntary Device Correction for PadPro and R2 Multi-function Defibrilla...Nov 26, 2014 - CONMED Corporation announces that it has notified customers of a Voluntary Urgent Device Correction for certain PadPro and R2 Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillator Units. These electrodes will not connect with Philips FR3 or FRx AED units.Nov 25, 2014 - Henry’s Farm Inc. of Woodford, VA is recalling all packages of Soybean Sprouts because they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals with weakened immune systems. Although healthy individuals may suffer only short term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
- Consumer Health Info
Dec 17, 2014 - Got questions about the foods, drugs and other issues involving your pet? FDA's Center for Veterinary Medicine (CVM) may be able to answer them. Read these seven frequently asked questions, and CVM's answers.Dec 16, 2014 - FDA officials are concerned over the marketing of fetal keepsake videos and over-the-counter Doppler ultrasound heartbeat monitors.Dec 12, 2014 - FDA warns consumers about an undeclared ingredient in a coffee drink, a risk of infection from a children’s supplement, and a sexual enhancement product that contains the active ingredient found in Viagra.Dec 3, 2014 - The Food and Drug Administration is helping women and their health care providers to learn more about the effects of medicines during pregnancy and breastfeeding.Dec 3, 2014 - Pregnant women who are prescribed a drug may worry of the potential impact on their developing fetuses. FDAÃƒÂ¢Ã¢â€šÂ¬Ã¢â€žÂ¢s pregnancy registries can help ease that worry.Dec 2, 2014 - FDA is working hard to make sure you have the information you need to make informed decisions about your health.Dec 1, 2014 - Continuous glucose monitoring technology alerts patients to low and high blood sugar levels, including how quickly they are changing.Nov 17, 2014 - Sometimes a cold is just a cold. What can worried parents do when their babies and young children have a cold? FDA has some advice and tips.Nov 14, 2014 - FDA warns consumers about baby wipes that may contain bacteria, undeclared drugs found in a product sold as a dietary supplement with weight loss claims, and a pain reliever packaging mix up.Nov 14, 2014 - To implement the section of the Affordable Care Act related to nutrition labeling, FDA is publishing final rules that require calorie information to be listed on menus and menu boards, and near self-serve foods and foods on display in certain chain restaurants, food stores, entertainment venues, and vending machines. The goal is to help consumers make more informed choices about what they eat away from home.Nov 12, 2014 - Food and Drug Administration analysts and entomologists investigate product samples and protect consumers from spoiled and contaminated food.Nov 5, 2014 - This guide provides tips and a quick-reference chart to help you report a problem to FDA.Nov 3, 2014 - If you eat meat or drink milk, you want to know: Are the veterinary drugs used in food-producing animals entering your diet? And if they are, are the amounts safe for human consumption? Those are some of the concerns of FDA's Division of Residue Chemistry.Oct 31, 2014 - Got a question about a medicine? FDA's Division of Drug Information can answer it.Oct 29, 2014 - Mammograms are still the best tool for breast cancer screening. As we observe Breast Cancer Awareness Month this October, learn how FDA certifies facilities that perform mammographyÃ¢â‚¬â€�and, clears and approves mammography devicesÃ¢â‚¬â€�to help keep you safe.Oct 28, 2014 - How does FDA ensure that generic prescription drugs are safe and effective alternatives to brand-name drugs? The generic drugs approval process includes a review of scientific data on manufacturing, ingredients and performance. Plus, FDA tests selected drugs, both brand-name and generic, in its laboratories.Oct 27, 2014 - Is mixing medicines and dietary supplements a good idea? Find out how using them together can endanger your health and why it's important to discuss them with your health care professional.Oct 23, 2014 - Undeclared allergens are the leading cause of food recalls by the FDA. Which foods are most often affected, and which allergens are involved?Oct 16, 2014 - The Food and Drug Administration's Office of International Programs has offices around the world. Learn how the agency is working with Mexico.Oct 15, 2014 - At FDA's National Center for Toxicological Research, investigators are researching pediatric brain function; and they've developed an innovative tool.
- News Releases
Dec 17, 2014 - The U.S. Food and Drug Administration today approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear.Dec 16, 2014 - The U.S. Food and Drug Administration today approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI).Dec 16, 2014 - The U.S. Food and Drug Administration today announced the membership of the Pharmacy Compounding Advisory Committee. The committee is comprised of 14 members - 12 voting and two non-voting - who will provide advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.FDA allows marketing of the first newborn screening test to help detect Severe Combined Immunodefic...Dec 15, 2014 - Today, the U.S. Food and Drug Administration (FDA) allowed marketing of the EnLite Neonatal TREC Kit, the first screening test permitted to be marketed by FDA for Severe Combined Immunodeficiency (SCID) in newborns.Dec 15, 2014 - The U.S. Food and Drug Administration today cleared a new screening test that predicts a patient’s risk of future coronary heart disease (CHD) events, such as heart attacks.Dec 15, 2014 - The U.S. Food and Drug Administration today announced that it granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of healthcare settings.Dec 12, 2014 - The U.S. Food and Drug Administration today expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC).Dec 12, 2014 - William H. Oshiro, owner of RZM Food Factory, has agreed to stop processing and distributing food until he demonstrates to the FDA that RZM Food Factory’s facility and practices comply with federal food safety requirements. The agreement, known as a consent decree of permanent injunction, was signed by a federal judge and entered in the U.S. District Court of Hawaii on Dec. 12, 2014.Dec 11, 2014 - The U.S. Food and Drug Administration today approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II). This test is intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive on an FDA-licensed HTLV-I/II blood donor screening test. The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay test intended to confirm infection with HTLV and to differentiate between HTLV-I and HTLV-II.Dec 10, 2014 - The U.S. Food and Drug Administration today approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers.OtisMed Corporation, former CEO plead guilty for distributing FDA-rejected cutting guides for knee ...Dec 8, 2014 - OtisMed Corporation (OtisMed) and its former chief executive officer, Charlie Chi, admitted today to intentionally distributing knee replacement surgery cutting guides after their application for marketing clearance had been rejected by the U.S. Food and Drug Administration.Dec 4, 2014 - Main Street Family Pharmacy, LLC, a compounding pharmacy in Newbern, Tennessee, and the company’s co-owner, David A. Newbaker, each pleaded guilty today in the United States District Court for the Western District of Tennessee to one misdemeanor criminal violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).Dec 4, 2014 - The U.S. Food and Drug Administration today approved a new use for Jakafi (ruxolitinib) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Jakafi is the first drug approved by the FDA for this condition.California seafood company to halt production until FDA documents correction of unsanitary practicesDec 4, 2014 - On December 1, a federal judge from the U.S. District Court for the Central District of California entered a consent decree of permanent injunction against Neptune Manufacturing, Inc., of Los Angeles, and its owners, Alexander Goldring, Peter Oyrekh and Semyon Krutovsky.Dec 3, 2014 - The U.S. Food and Drug Administration today approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.FDA issues final rule on changes to pregnancy and lactation labeling information for prescription d...Dec 3, 2014 - The U.S. Food and Drug Administration published a final rule today that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.Nov 26, 2014 - The U.S. Food and Drug Administration today allowed marketing of the HeartFlow FFR-CT software, which permits health care professionals to non-invasively evaluate blood flow in the coronary arteries of patients showing signs and symptoms of coronary artery disease.Nov 25, 2014 - The U.S. Food and Drug Administration today finalized two rules requiring that calorie information be listed on menus and menu boards in chain restaurants, similar retail food establishments and vending machines with 20 or more locations to provide consumers with more nutritional information about the foods they eat outside of the home. The rules are required by the 2010 Patient Protection and Affordable Care Act.Nov 24, 2014 - Today, the U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.Nov 21, 2014 - The U.S. Food and Drug Administration, in a complaint filed by the Department of Justice, is seeking to stop Scotty’s Incorporated, of Detroit, Michigan, which does business as Bruce Enterprises and Bruce’s Fresh Products, and Sandra J. Jackson, the firm’s co-owner and manager, from preparing and distributing ready-to-eat sandwiches.