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- FDA Alerts
- Recalls (Drug & Food)
May 19, 2015 - A&S FOOD TRADING INC at 4425B 1ST AVE, BROOKLYN, NEW YORK 11232 is recalling HUA ZHI YING BRAND GOURD CANDY because it contains undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.Aurora Products, Inc. Announces Voluntarily Recall of Aurora Natural Brand and Certain Private Labe...May 15, 2015 - Aurora Products, Inc. is conducting a voluntary recall of RAW MACADAMIA NUTS packaged under the Aurora brand label and various Store brand labels. Products are being recalled because they have the potential to contain Salmonella 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.OC Raw Dog Recalls Turkey & Produce Raw Frozen Canine Formulation Because of Possible Salmonella He...May 15, 2015 - OC Raw Dog of Rancho Santa Margarita, CA is voluntarily recalling 2055 lbs. of Turkey & Produce Raw Frozen Canine Formulation, 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.Natural Creations Issues Allergy Alert on Undeclared Milk Ingredient in Dietary Supplement New Zeal...May 15, 2015 - Natural Creations of Woodbine, IA is recalling a small quantity of Natural Creations New Zealand Colostrum because the label does not inform consumers that the product is milk-based. People who have an allergy or severe sensitivity to milk protein run the risk of serious allergic reaction if they consume this product.May 11, 2015 - New York State Agriculture Commissioner Richard A. Ball today alerted consumers to undeclared peanuts in Crown Food International "Cummin Powder," packaged and distributed by Crown Food International LLC, located at 45-30 38th St, Long Island City, NY 11101. People who have severe sensitivity to peanuts may run the risk of serious or life-threatening reactions if they consume this product.May 11, 2015 - Good Seed Inc. of Springfield, VA is recalling all packages of soybean sprouts and mung bean sprouts because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals with weakened immune systems.Golden Krust Caribbean Bakery & Grill Issues Allergy Alert on Undeclared Egg in Jamaican Style Shri...May 6, 2015 - Golden Krust Caribbean Bakery & Grill of Bronx, NY is recalling 6,188 cases of Shrimp and Soya Patties, Net Wt. 17.2 lbs, due to an undeclared egg allergen. People who have an allergy or severe sensitivity to eggs 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...May 4, 2015 - Teva Parenteral Medicines today announced a voluntary recall of eight lots of Adrucil® (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.Poco Dolce Confections Announces Recall of Individually Wrapped Tile Varieties: Almond, Aztec Chile...May 4, 2015 - Poco Dolce Confections of San Francisco, CA is recalling all Almond, Aztec Chile, Burnt Caramel, Almond Coconut, Ginger, and Sesame Toffee Individually Wrapped Tiles. These varieties of individually wrapped Tiles are being recalled because of their label’s failure to identify the food allergen (Milk) in addition to the listing for “Butter” in the label’s ingredient statement.May 4, 2015 - Kent Nutrition Group, Inc. is recalling one lot of its Blue Seal Home Fresh Starter Amp Medicated Poultry Feed. The recall is being implemented due to the discovery of excess salt in the feed concerning lot number 1015072.May 1, 2015 - Sun Rich Fresh Foods Inc. of Richmond, BC, Canada is voluntarily recalling sliced apple and products containing sliced apples, from its Northeast Fresh Facility located in Brampton, ON, Canada 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.Apr 29, 2015 - NAVAJO PRIDE, LLC of FARMINGTON, NM is issuing a voluntary recall of Bleached All Purpose Flour Lot#075B110064, expiration date 03162016 (“Product”) 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 29, 2015 - On April 27, 2015, Hy-Vee, Inc. issued a recall for Hy-Vee Summer Fresh Pasta Salad that is sold in its stores' kitchen department cold cases and salad bars. The pasta was recalled after Hy-Vee was notified the frozen vegetables used to make the ready-to-eat pasta were potentially contaminated with Listeria monocytogenes.Apr 27, 2015 - Waymouth Farms, Inc. of New Hope, MN is recalling RAW PINE NUTS in various sizes, 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.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).
- Consumer Health Info
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.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.
- News Releases
May 19, 2015 - The U.S. Food and Drug Administration proposed a rule today that would require animal drug sponsors of all antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales by major food-producing species (cattle, swine, chickens and turkeys). The additional data would improve understanding of how antimicrobials are sold or distributed for use in major food-producing animals and help the FDA further target its efforts to ensure judicious use of medically important antimicrobials.May 18, 2015 - As part of its overall efforts to address compounded drugs, the U.S. Food and Drug Administration today released a draft “Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances.”May 8, 2015 - Today the U.S. Food and Drug Administration approved the Senza spinal cord stimulation (SCS) system (Senza System) as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain. The Senza System can reduce pain without producing a tingling sensation called paresthesia by providing high frequency stimulation (at 10 KHz) and low stimulation amplitudes.May 8, 2015 - The U.S. Food and Drug Administration today approved Avelox (moxifloxacin) to treat patients with plague, a rare and potentially fatal bacterial infection. The agency approval for plague includes use of the drug for the treatment of pneumonic plague (infection of the lungs), and septicemic plague (infection of the blood). Avelox is also approved for prevention of plague in adult patients.Apr 30, 2015 - The U.S. Food and Drug Administration today approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by the agency. It is used to help control bleeding during surgery.FDA issues proposed rule to address data gaps for certain active ingredients in health care antisep...Apr 30, 2015 - The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph.Apr 29, 2015 - The U.S. Food and Drug Administration today approved Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. Using Kybella for the treatment of fat outside of the submental area is not approved and is not recommended.Apr 28, 2015 - The U.S. Food and Drug Administration today approved the first generic versions of Abilify (aripiprazole). Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder.Apr 27, 2015 - The U.S. Food and Drug Administration announced today the filing of a consent decree against Medtronic, Inc., and two of the company’s officers—S. Omar Ishrak and Thomas M. Tefft —for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. These violations occurred at the company’s Neuromodulation facilities in Columbia Heights, Minnesota, where the devices are manufactured.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.