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- FDA Alerts
- Recalls (Drug & Food)
Jul 28, 2015 - Cincinnati, Ohio - July 25, 2015 - The Kroger Co. said today it is recalling Kroger Ground Cinnamon, Kroger Garlic Powder, Kroger Coarse Ground Black Pepper and Kroger BacÃƒÆ’Ã‚Â¢ÃƒÂ¢Ã¢â‚¬Å¡Ã‚Â¬ÃƒÂ¢Ã¢â‚¬Å¾Ã‚Â¢n Buds sold in its retail stores due to possible contamination from Salmonella. A sample of Kroger Garlic Powder from a store in North Augusta, South Carolina was tested by the FDA and found to be contaminated with Salmonella.Jul 28, 2015 - KellBran Candies of Akron, Ohio is recalling KellBran Caramel Popcorn, because it contains undeclared milk product. People who have an allergy or severe sensitivity to milk, run the risk of serious or life-threatening allergic reaction if they consume these products.Teva Parenteral Medicines Initiates Voluntary Nationwide Recall of Select Lots of Adrucil (Fluorour...Jul 27, 2015 - Teva Parenteral Medicines today announced a voluntary recall of six lots of AdrucilÂ® (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. The recalled lots are as follows:Nature's Variety Issues Nationwide Voluntary Recall of Instinct Raw Chicken Formula Because of Poss...Jul 24, 2015 - Nature’s Variety has announced a voluntary recall of their Instinct® Raw Chicken Formula for dogs with a “Best By” date of 04/27/16 because these products may be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.Moses Lake Professional Pharmacy Issues Voluntary Recall of Unexpired Sterile Human and Veterinary ...Jul 24, 2015 - Moses Lake Professional Pharmacy is voluntarily recalling human and veterinary sterile compounded drugs which are unexpired to the consumer level due to lack of sterility assurance. The company has not received any reports of product contamination or adverse events to date, and is issuing this voluntary recall out of an abundance of caution following a recent inspection which identified an issue with sterility assurance.Jul 24, 2015 - Bravo Pet Foods of Manchester, CT is recalling select lots of Bravo Chicken pet foods for dogs and cats due to concerns of the possible presence of Salmonella. The recall was initiated after routine testing by the New York State Department of Agriculture revealed the presence of Salmonella spp. Poly A contamination.Life & More, L.L.C. Issues Nationwide Voluntary Recall of Akttive High Performance Fat Burner Gold ...Jul 23, 2015 - Life & More, L.L.C. is voluntarily recalling 783 Bottles from Lot #000185004400 Akttive High Performance Fat Burner Gold capsules weight loss supplements. The firm was informed by the US Food and Drug Administration (FDA) that a sample of Akttive High Performance Fat Burner Gold capsules was found to contain Sibutramine, desmethylsibutramine, and Phenolphthalein.Osamu Corporation Voluntarily Recalls Frozen Tuna Products from Distributors Due To Potential Healt...Jul 21, 2015 - July 20, 2015 -Osamu Corporation of Gardena, CA is recalling all of its frozen tuna (loin, saku, chunk, slice, and ground market forms) sourced from one processing plant in Indonesia because the Minnesota Department of Health Investigators found samples of this product from one retail location in Minnesota 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. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.Persons developing these symptoms should seek medical attention.Jul 21, 2015 - Osamu Corporation of Gardena, CA is recalling Frozen Yellow Fin Tuna Chunk Meat (Lot #68568) sold to AFC Corporation of Rancho Dominquez, CA sourced from one processing plant in Indonesia because the Minnesota Department of Health Investigators found samples of this product from one retail location in Minnesota 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. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.The Natural Dog Company, Inc. Recalls 12" Tremenda Sticks Because of Possible Salmonella Health RiskJul 21, 2015 - The Natural Dog Company, Inc. of Windsor, CO, is recalling its 12oz bags of 12" Tremenda Sticks pet chews because they have the potential to be contaminated with Salmonella. Salmonella can affect animals eating the product and there is risk to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.Barrel O' Fun Snack Foods Co. Issues Allergy Alert On Undeclared Milk In Vic's Original Popcorn (1-...Jul 20, 2015 - Barrel O' Fun Snack Foods Co. of Perham, MN is recalling one specific lot of Vic's Original White Popcorn 1-1/8oz size bags (UPC 0-46555-00062-1) because it may contain an undeclared milk allergen. People with an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reactions if they consume this product.Baxter Initiates Voluntary Recall Of Two Lots Of IV Solutions Due To The Potential Presence Of Part...Jul 20, 2015 - Baxter International Inc. announced today it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint.Updated Press Release - It Takes A Village Foods LLC. Dba Veggie Evolution Issues An Allergy Alert ...Jul 17, 2015 - It Takes a Village Foods LLC of Hailey, ID is recalling Ã¢â‚¬Å“Veggie Evolution Kale Crisps Zen NoriÃ¢â‚¬ï¿½ because it contains undeclared soy. People who have allergy or severe sensitivity to soy run the risk of serious or life threatening allergic reaction if they consume this product. Veggie Evolution Kale Crisps Zen Nori was distributed to retail stores in Arizona, California, Colorado, Idaho, Montana, Michigan, Oregon, Utah, and also sold on line at Ã¢â‚¬Å“VeggieEvolution.comÃ¢â‚¬ï¿½.Jul 16, 2015 - SUPERVALU INC. of Eden Prairie, Minn. is recalling 4ct. 13oz packages of Cub Foods and Rainbow Foods Danish Rolls because it may contain undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.Jul 15, 2015 - D&D Foods, Inc., based in Omaha, Nebraska, is recalling 3-pound containers of Hy-Vee American Macaroni Salad because they were incorrectly labeled and may contain undeclared milk and wheat (gluten). People who have an allergy or severe sensitivity to milk and wheat (gluten) run the risk of serious or life-threatening allergic reaction if they consume these products.Jul 14, 2015 - Homemade of Leavenworth, Washington is recalling pickle and sauce products because they may have been improperly produced. Washington State Department of Agriculture routine sampling discovered that a bottle of Homemade Bread and Butter Pickles had a pH level high enough to allow the growth of Clostridium botulinum. Required records were not available to support that safe processing guidelines were followed on all sauce and pickle products produced at Homemade.Jul 14, 2015 - FOR IMMEDIATE RELEASE - July 13, 2015 – In April 2015, Mylan Institutional conducted a voluntary market withdrawal of 14 lots of Calcium Chloride Intravenous Infusion 10%w/v, packaged in 10 mL prefilled syringes (listed below). In June 2015, Mylan Institutional issued a second notification of the market withdrawal.Jul 13, 2015 - Nectar Foods, Inc. of Portland, Oregon is recalling 300 CocoNoNut CACAO-NECTAR BAR’s because it may contain undeclared almonds. People who have an allergy or severe sensitivity to almond run the risk of serious or life-threatening allergic reaction if they consume these products.Jul 10, 2015 - Maya Overseas Foods Inc. of Maspeth, NY, is recalling approximately 8000 lbs. of Cashew Split 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. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.Jul 10, 2015 - Carnivore Meat Company, LLC is recalling select products and lots of Carnivore Vital Essentials pet foods because they have the potential to be contaminated with Listeria monocytogenes. Healthy cats and dogs rarely become sick from Listeria monocytogenes. In humans, however, Listeria is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems
- Consumer Health Info
Jul 28, 2015 - FDA is warning consumers about the Daytrana patch, ventricular assist systems, and a vascular patch.Jul 9, 2015 - FDA is strengthening the existing prescription and Drug Facts labels warning that nonsteroidal anti-inflammatory drugs (NSAIDs) ÃƒÂ¢Ã¢â€šÂ¬Ã¢â‚¬Å“ a group of drugs used for the temporary relief of pain and fever ÃƒÂ¢Ã¢â€šÂ¬Ã¢â‚¬Å“ can increase the chance of a heart attack or stroke, either of which can lead to death.Jul 1, 2015 - FDA is taking action against 16 prescription drugs labeled to relieve ear pain and swelling because they are unapproved and haven't been evaluated by FDA for safety, effectiveness and quality. Parents and other consumers still will have many other options for treating ear pain.Jun 25, 2015 - FDA is warning consumers about problems with mammograms at Coastal Diagnostic Center, Calif., and illegal Ebola Virus Test Kits.Jun 23, 2015 - Results of the National Youth Tobacco Survey provide a snapshot of tobacco products used by today's youth and reveal some surprising new trends.Jun 16, 2015 - FDA is taking action which will significantly reduce harmful trans fat in the U.S. food supply.Jun 8, 2015 - Occasionally pet foods and treats can be contaminated with harmful bacteria and can make pets, and sometimes owners, sick. FDA is studying this issue to help keep you and your four-legged friends safeJun 3, 2015 - Don't let expired or unused medicines collect in your home. Learn about community take-back programs, including the annual National Prescription Drug Take Back Day, and other ways to dispose of unused drugs safely.May 21, 2015 - FDA is releasing more information about its study finding that some dark chocolate products contain varying amounts of milk. And you can't always tell that's the case simply by reading the food label.May 13, 2015 - FDA reviews a study about a psychiatric drug, and warns consumers about mislabeled over-the-counter medicine, certain human and veterinary drugs, certain homeopathic products, and mammograms performed at a medical practice in North Carolina.May 8, 2015 - MotherÃ¢â‚¬â„¢s Day is May 11, an exciting time for new moms. But moms (and dads) of babies 12 months and younger can also have some worries. FDA medical officers offer health suggestionsApr 22, 2015 - FDA warns consumers about unapproved drugs in a weight loss pill, risk of side effects from a psychiatric drug, and an undeclared drug in a herbal supplement.Apr 20, 2015 - Colorectal cancer is preventable and, if caught early enough, treatable. FDA explains who should get screened and when.Apr 8, 2015 - The Food and Drug Administrationâ€™s Office of Communications has concluded a Memorandum of Understanding with Healthline.com, which has agreed, a.o., to post FDA Consumer Updates and other content on its website, produce a newsletter and alerts that feature FDA content, and provide direct links back to FDA web content such as the agencyâ€™s RSS feed for product recalls.Mar 23, 2015 - FDA recommends manufacturers stop using "latex-free" label because all products contain some natural rubber latex proteins.Mar 23, 2015 - FDA continues to warn companies when they make drug claims about cosmetic products that have not been approved by the agency.Mar 6, 2015 - The Food and Drug Administration (FDA) is approving Zarxio (filgrastim-sndz), the first biosimilar product (or biosimilar), and expects to approve others in the months ahead. What are biosimilars? How will they affect patient treatment?Jan 27, 2015 - Scientists are working to develop breakthrough therapies for pancreatic cancer, one of the deadliest cancers that affects both men and women. FDA has approved three treatments for advanced pancreatic cancer to help patients live longer.Jan 15, 2015 - Have an overactive bladder? FDA-approved treatments can help adults of any age control their symptoms and live an active life.Jan 5, 2015 - Many so-called miracle weight loss supplements and foods (including teas and coffees) don't live up to their claims. Worse, they can cause serious harm.
- News Releases
Jul 28, 2015 - The U.S. Food and Drug Administration today approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is intended to facilitate weight loss in obese adult patients. The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.Jul 24, 2015 - The U.S. Food and Drug Administration today approved Praluent (alirocumab) injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.Jul 24, 2015 - The U.S. Food and Drug Administration today approved Daklinza (daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections. Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.Jul 24, 2015 - The U.S. Food and Drug Administration today approved Odomzo (sonidegib) to treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy.Jul 24, 2015 - The U.S. Food and Drug Administration today approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis).Jul 24, 2015 - The U.S. Food and Drug Administration today proposed including the percent daily value (%DV) for added sugars on the Nutrition Facts label of packaged foods, giving consumers additional information for added sugars similar to information they have seen for decades with respect to nutrients such as sodium and certain fats.Jul 23, 2015 - The U.S. Food and Drug Administration today approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay, the first FDA-approved diagnostic that differentiates between HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum or plasma specimens.Jul 22, 2015 - The U.S. Food and Drug Administration today announced the winners of the 2014 FDA Food Safety Challenge, a prize competition to advance breakthrough ideas on how to find disease-causing organisms in food – especially Salmonella in fresh produce. The grand prize winner and runner-up winner will receive $300,000 and $100,000 in prize money, respectively.Jul 16, 2015 - The U.S. Food and Drug Administration today authorized use of the first prosthesis marketed in the U.S. for adults who have amputations above the knee and who have rehabilitation problems with, or cannot use, a conventional socket prosthesis.FDA approves targeted therapy for first-line treatment of patients with a type of metastatic lung c...Jul 13, 2015 - The U.S. Food and Drug Administration today approved Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.FDA approves new drug to treat schizophrenia and as an add on to an antidepressant to treat major d...Jul 13, 2015 - On July 10, the U.S. Food and Drug Administration approved Rexulti (brexpiprazole) tablets to treat adults with schizophrenia and as an add-on treatment to an antidepressant medication to treat adults with major depressive disorder (MDD).Jul 10, 2015 - On July 10, 2015, the United States District Court for the District of Nevada entered a consent decree of permanent injunction against Bio Health Solutions LLC, of Las Vegas and its manager and co-owner, Mark Garrison, for selling RenAvast, an unapproved animal drug.Jul 7, 2015 - The U.S. Food and Drug Administration today approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure.Jul 2, 2015 - The U.S. Food and Drug Administration today approved the first drug for cystic fibrosis directed at treating the cause of the disease in people who have two copies of a specific mutation.Jul 1, 2015 - A federal judge for the District of New Jersey has entered a consent decree of permanent injunction between the United States and Acino Products LLC (Acino), of Hamilton, New Jersey, and the company’s president, Ravi Deshpande, for marketing unapproved and misbranded prescription drugs.Jul 1, 2015 - The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation.Jun 26, 2015 - Today, the U.S. District Court of the District of New Jersey sentenced the OtisMed Corporation’s (OtisMed) former chief executive officer, Charlie Chi, to 24 months in prison and also ordered him to serve one year of supervised release and to pay a $75,000 fine.Jun 22, 2015 - The U.S. Food and Drug Administration today approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. It is approved for adult patients undergoing percutaneous coronary intervention (PCI), a procedure used to open a blocked or narrowed coronary artery to improve blood flow to the heart muscle.Jun 18, 2015 - The Food and Drug Administration today allowed marketing of a new device that when used along with other assistive devices, like a cane or guide dog, can help orient people who are blind by helping them process visual images with their tongues.FDA takes action to protect consumers from potentially dangerous counterfeit medicines and devices ...Jun 18, 2015 - The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 1,050 websites that illegally sell potentially dangerous, unapproved prescription medicines and medical devices to consumers. These actions include the issuance of regulatory warnings to the operators of offending websites and seizure of $81 million worth of illegal medicines and medical devices worldwide.