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- FDA Alerts
- Recalls (Drug & Food)
TFH Publications, Inc./Nylabone Products Recalls Puppy Starter Kit Due To Possible Salmonella Healt...Apr 25, 2015 - TFH Publications, Inc./Nylabone Products, of Neptune, NJ is recalling one lot of its 1.69 oz. package of the Puppy Starter Kit dog chews, because they have the potential to be contaminated with Salmonella. Salmonella can affect animals ingesting 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.Greystone Foods, LLC voluntarily recalls Todays Harvest Field Peas with Snaps, Silver Queen Corn, a...Apr 24, 2015 - Greystone Foods, LLC voluntarily recalls Today’s Harvest Field Peas with Snaps, Silver Queen Corn, and Broccoli Florets with the sell by date 04/21/16 shipped to Publix Supermarkets warehouse in Lakeland, FL warehouse due to possible health risk.Mylan Initiates Voluntary Nationwide Recall of Select Lots of Injectable Products Due to the Presen...Apr 24, 2015 - Mylan N.V. (Nasdaq: MYL) today announced that its U.S.-based Mylan Institutional business is conducting a voluntary nationwide recall to the hospital/user level of select lots of the following injectable products due to the presence of visible foreign particulate matter observed during testing of retention samples.Sweet Sam's Baking Company Issues Allergy Alert on Undeclared Milk in Starbucks Black & White Mini ...Apr 24, 2015 - Sweet Sam's Baking Company of Bronx, NY is recalling all lots of Starbucks Black & White Mini Cookies sold in Starbucks Company operated stores on or before Thursday, April 23rd, 2015, because they contain milk, an allergen that is not declared on the packaging. People who have an allergy to milk run the risk of experiencing a serious or life-threatening reaction if they consume the product.Apr 24, 2015 - Jeni’s Splendid Ice Creams has initiated a voluntary recall of all ice creams, frozen yogurts, sorbets, and ice cream sandwiches for all flavors and containers because of the possible presence of Listeria monocytogenes. The company is ceasing all sales and closing all scoop shops until all products are ensured to be 100% safe.Hospira Issues A Voluntary Nationwide Recall Of One Lot Of Bupivacaine HCl Injection Due To Potenti...Apr 24, 2015 - Hospira, Inc., (NYSE: HSP) has announced today it is issuing a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose (NDC: 0409-1162-02, Lot 38-515-DK, Expiry 1FEB2016) due to one confirmed customer complaint of orange and black, visible particles embedded and free floating within a single-dose glass teartop vial. The particles were identified as iron oxide. This recall is being carried out to the user level (both human and veterinary).Inventure Foods, Inc. Issues Voluntary Recall of Its Fresh Frozen Vegetables and Select Jamba "At H...Apr 23, 2015 - Inventure Foods, Inc. has issued a voluntary recall of certain varieties of its Fresh Frozen line of frozen vegetables, as well as select varieties of its Jamba "At Home" line of smoothie kits, due to finding of Listeria monocytogenes, in its Jefferson, GA facility. Listeria is an organism that can cause infections in young children, frail or elderly people, and others with weakened immune systems.SM Fish Corp. Issues Allergy Alert On Undeclared Milk In Ossies Herring In Sourcream And Ossies Pic...Apr 22, 2015 - SM Fish Corp. of FAR ROCKAWAY, NY is recalling 8 ounce containers of OSSIES HERRING IN SOURCREAM and OSSIES PICKLED LOX DAIRY because they contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reactions if they consume these products.Apr 22, 2015 - SM Fish Corp. of FAR ROCKAWAY, NY is recalling 8 ounce containers of OSSIEâ€™S PICKLED LOX & CREAM because it contains undeclared eggs.Â People who have an allergy to eggs run the risk of serious or life-threatening allergic reaction if they consume this product.RB Issues Voluntary Recall of Liquid Bottles of MUCINEX FAST-MAX Night Time Cold & Flu; MUCINEX FAS...Apr 22, 2015 - Parsippany, NJ, RB (formerly Reckitt Benckiser) has recalled certain lots of liquid bottles of MUCINEX® FAST-MAX® Night Time Cold & Flu; MUCINEX® FAST-MAX® Cold & Sinus; MUCINEX® FAST-MAX® Severe Congestion & Cough and MUCINEX® FAST-MAX® Cold, Flu & Sore Throat because the over-the-counter medications, which correctly label the product on the front of the bottle and lists all active ingredients, may not have the correct corresponding drug facts label on the back. This recall was due to a confirmed report from a retailer.Apr 21, 2015 - State Agriculture Commissioner Richard A. Ball today warned consumers not to consume La Clarita Queseria Queso Fresco “Fresh Cheese” made by Queseria La Poblanita, Inc., 216 E. 117th St., New York, NY, 10035, due to possible Staphylococcus aureus contamination. To date, no illnesses are known by the Department of Agriculture and Markets to be associated with this product.Blue Bell Creameries Voluntarily Expands Recall to Include All of its Products Due to Possible Heal...Apr 21, 2015 - Blue Bell Ice Cream of Brenham, Texas, is voluntarily recalling all of its products currently on the market made at all of its facilities including ice cream, frozen yogurt, sherbet and frozen snacks because they have 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 headaches, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.Apr 20, 2015 - Royal Frozen Food is recalling its BLINTZES products due to undeclared milk. The products contain milk, a known allergen, which is not declared on the product label. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products.Apr 20, 2015 - Superior Nut & Candy Co., Inc. is recalling 4 ounce packages Pine Nuts because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people, and other with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.Apr 17, 2015 - PROLAINAT is voluntarily recalling all lots of 9.16 oz packages of Trader Joes A Dozen Sweet Bites (Chocolate & Coffee Opera Cake, Raspberry Macaron Aux Framboises Cake, Caramel & Chocolate Cake) due to undeclared coconut. People who have an allergy or sensitivity to coconut run the risk of serious or life threatening allergic reaction if they consume the product. The Trader Joes A Dozen Sweet Cakes is safe for consumption by those who do not have coconut allergies.Apr 17, 2015 - Whole Foods Market is voluntarily recalling packaged raw macadamia nuts due to possible Salmonella contamination. 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. Healthy persons infected with Salmonella often experience fever, diarrhea, 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.Apr 17, 2015 - Hines Nut Company, Dallas, TX, today announced a voluntary recall of WALNUT HALVES & PIECES, Lot Number 6989.Â The product was supplied by GOLD STATE NUT COMPANY of Biggs, CA, and packaged by Hines Nut Company. There is a possibility these nuts may be contaminated with Salmonella.Conway Import Co., Inc. is Voluntarily Recalling Conway Organic Sesame Ginger Dressing and Conway C...Apr 17, 2015 - Conway Import Co., Inc. is recalling Conway Organic Sesame Ginger Dressing and Conway Citrus Organic Vinaigrette Dressing 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.Apr 17, 2015 - Schnuck Markets, Inc. of St. Louis, Mo. is recalling its Chef’s Express California Pasta Salad sold in its Deli/Chef’s Express departments April 2 – April 14, 2015 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. In rare circumstances, infection with Salmonella can result in the organism getting in the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms, endocarditis and arthritis.Apr 16, 2015 - Smiths Food and Drug Stores said today it is recalling select Smiths Bakery Fresh Carrot Cake sold in 7 states because the product contains walnuts that may not be listed on the label.
- Consumer Health Info
Apr 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?Feb 11, 2015 - If you or someone in your household is allergic to milk, take heed: a recent study by FDA found that many of the dark chocolate products contain milk. And you canÃ¢â‚¬â„¢t always tell thatÃ¢â‚¬â„¢s the case simply by reading the food label.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.Dec 23, 2014 - In much of the Northern Hemisphere, this is prime time for colds, influenza (flu), and other respiratory illnesses. While contagious viruses are active year-round, fall and winter are when we're all most vulnerable to them.Dec 19, 2014 - When operated unsafely, or without certain controls, the highly-concentrated light from lasersâ€”even those in toysâ€”can be dangerous, causing serious eye injuries and even blindness. FDA has issued draft guidance on the safety of toy laser products to protect children from harm.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 childrenâ€™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.
- News Releases
Apr 23, 2015 - On April 22, 2015, the United States District Court for the Northern District of Illinois entered a consent decree of permanent injunction against Wholesome Soy Products Inc., of Chicago, Illinois, owner Julia Trinh, and manager Paul Trinh, following multiple findings of contaminated food and environmental samples by the U.S. Food and Drug Administration.Apr 17, 2015 - The U.S. Food and Drug Administration today approved the KAMRA inlay, a device implanted in the cornea of one eye (the clear, front surface) to improve near vision in certain patients with presbyopia. It is the first implantable device for correction of near vision in patients who have not had cataract surgery.Apr 16, 2015 - The U.S. Food and Drug Administration today approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS).Apr 16, 2015 - At the request of the U.S. Food and Drug Administration and the U.S. Attorney for the Southern District of Florida, U.S. Marshals seized unapproved prescription drug products valued at over $1,500,000 from Stratus Pharmaceuticals, Inc., of Miami, Florida. Stratus Pharmaceuticals marketed and distributed unapproved prescription drug products that were manufactured by Sonar Products, Inc., of Carlstadt, New Jersey.Apr 15, 2015 - The U.S. Food and Drug Administration today approved Corlanor (ivabradine) to reduce hospitalization from worsening heart failure.Apr 13, 2015 - The U.S. Food and Drug administration is warning consumers to stop using a dietary supplement for muscle growth linked to serious liver injury.Apr 6, 2015 - The U.S. Food and Drug Administration today approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test to aid in the diagnosis of delayed gastric emptying, known as gastroparesis.Massachusetts dairy operation agrees to permanent injunction to prevent illegal drug residues in an...Apr 3, 2015 - On April 3, 2015, the U.S. District Court for the District of Massachusetts on behalf of the U.S. Food and Drug Administration has filed a consent decree of permanent injunction against Michael P. Ferry Inc., a dairy operation located in Westport, Massachusetts, and owner Michael P. Ferry after the FDA documented multiple violations of federal food laws.FDA alerts health care professionals and patients not to use products from the Prescription Center ...Apr 2, 2015 - The U.S. Food and Drug Administration is joining the North Carolina Board of Pharmacy (NC BOP) to urge health care professionals, including veterinarians, and patients not to use products made and distributed by the Prescription Center pharmacy, located at 915 Hay St., Fayetteville, North Carolina.Apr 1, 2015 - The U.S. Food and Drug Administration today issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.Mar 30, 2015 - The U.S. Food and Drug Administration today expanded the approved use of the CoreValve System to treat certain patients who have previously had a tissue aortic valve replacement and are in need of a second one.Mar 30, 2015 - At the request of the U.S. Food and Drug Administration, a judge has ordered L.A. Star Seafood Company Inc., located in Los Angeles, and its owners, Sima and Sam Goldring, to halt operations until they demonstrate to the FDA that they can process food in compliance with food safety laws and regulations.Mar 25, 2015 - The U.S. Food and Drug Administration today expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema.Mar 25, 2015 - The U.S. Food and Drug Administration today approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.FDA approves blood pump system to help patients maintain stable heart function during certain high-...Mar 23, 2015 - The U.S. Food and Drug Administration today approved the Impella 2.5 System, a miniature blood pump system intended to help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention (HRPCI) procedures, such as balloon angioplasty and stenting, which re-open coronary arteries that are narrowed or blocked due to severe coronary artery disease (CAD).Mar 20, 2015 - Today, the U.S. Food and Drug Administration completed its evaluation for two varieties of apples genetically engineered by Okanagan Specialty Fruits, Inc., and for six varieties of potatoes genetically engineered by J. R. Simplot Company and concluded that these foods are as safe and nutritious as their conventional counterparts.Mar 17, 2015 - Today the U.S. Food and Drug Administration approved Cholbam (cholic acid) capsules, the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders). Patients with these rare, genetic, metabolic conditions exhibit manifestations of liver disease, steatorrhea (presence of fat in the stool) and complications from decreased fat-soluble vitamin absorption.Mar 12, 2015 - The U.S. Food and Drug Administration today announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses.Mar 11, 2015 - U.S. District Judge Lee Yeakel entered a consent decree of permanent injunction on March 10, 2015 between the United States and Specialty Compounding LLC, of Cedar Park, Texas, and the company’s co-owners, Raymond L. Solano, III and William L. Swail. According to the complaint filed with the consent decree, Specialty Compounding manufactured purportedly sterile injectable drug products that tested positive for bacterial contamination. The U.S. Department of Justice brought the action on behalf of the U.S. Food and Drug Administration.Mar 10, 2015 - The U.S. Food and Drug Administration today approved Unituxin (dinutuximab) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children.