Feb 14, 2012 - Flight Medical Innovations Ltd. (Flight Medical) issued the following update regarding its voluntary recall of remote alarm cable, part number V24-00400-29, used to connect a Newport HT50 mechanical ventilator to a nurse station. The recalled cable may negatively affect Newport HT50 ventilators manufactured prior to 2007.

Feb 11, 2012 - Walmart recalled its eight-count packages of Cruller bakery pastries because the common name of milk was not listed following sodium caseinate, a milk derivative, on the ingredient label. People who have milk allergies that do not recognize sodium caseinate as a milk derivative run the risk of serious or life-threatening allergic reactions if they consume the product.

Feb 11, 2012 - Regeneca, Inc. announced today that it is conducting a voluntary nationwide recall of RegenArouse, Lot Number 130100, because FDA lab analysis has confirmed the presence of Tadalafil making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.

Feb 11, 2012 - Whole Foods Market is recalling its 3 ounce and 26 ounce Pumpkin Bundt Cakes because the products contain undeclared milk. No illnesses have been reported to date, however people who have allergies to milk, run the risk of serious or life-threatening allergic reaction if they consume these products.

Feb 10, 2012 - Summit Import Corp., at 100 Summit Place, Jersey City, New Jersey, is recalling Bin Bin Snow Rice Cracker 5.3oz Pack and Bin Bin Rice Cracker 15.8oz Bulk Pack because the affected products contain egg which are not declared on the label. Consumers who are allergic to eggs may run the risk of serious or life-threatening allergic reactions if they consume this product.

Feb 9, 2012 - Wholistic Herbs Inc. of Dallas, TX, is recalling all quantities of the following two, 1 fl. oz. spray products distributed from March 2009 through February 2012. Products intended for use in the eye that are non-sterile have the potential to cause eye infections, which may be sight threatening. Also, nasal solutions that are not sterile could lead to a respiratory infection.

Feb 9, 2012 - ZIP INTERNATIONAL GROUP LLC, 160 Raritan Center Parkway #6, Edison, NJ 08837 is expanding its recall of sliced herring fillet (forelka) 330 gram and 600 gram in plastic packaging due to Listeria contamination. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Feb 8, 2012 - In order to maintain the highest standards of product quality and safety for Spartan Stores, Michael Foods, Minnetonka, MN., a producer of hard-boiled eggs is initiating a voluntary product withdrawal on one lot code of hard-boiled eggs due to a possible contamination of Listeria monocytogenes.

Feb 8, 2012 - Grand Strand Sandwich Company of Longs, SC is recalling its 4.5oz and 5 oz Chicken Salad Sandwiches, with the following labels: Grand Strand Sandwich, Lunch Box Sandwiches, and Country Harvest Sandwiches.

Feb 6, 2012 - Under the direction of the FDA, North American Rescue, LLC (NAR) today announces the market recall of the NAR Surgical Crichothyroidotomy Kit or Crickit, due to potential contamination of the povidone iodine prep pads, manufactured by Triad Group. This recall is a follow up to the recall initiated on May 5, 2011. North American Rescue, LLC has successfully contacted 97% of our customers and requested they contact our customer service department for return instructions.

Feb 4, 2012 - Healthy People Co. announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplements sold under the brand names Healthy People Co. specific to the following Lot Numbers. Healthy People Co. is conducting a voluntary recall because FDA lab analysis has confirmed the presence of Sibutramine and Tadalafil, making these products unapproved new drugs.

Feb 4, 2012 - Nest Collective ™ announced today that it is voluntarily recalling 8150 selling units of its Jammy Sammy™ - Strawberry Jam & Peanut Butter Flavor Snack Size Sandwich Bars due to a mislabeled inner wrapper. The cartons contain the best by date June 28, 2012 and are marked with the following universal product code (UPC) #89676600116 6 located on the bottom of the package.

Feb 3, 2012 - GH Foods CA, LLC was notified by their supplier that the eggs supplied to them were from Michael Foods, Inc, who recalled Hard-Cooked eggs due to potential contamination by Listeria monocytogenes. GH Foods CA, LLC, Sacramento, California, is therefore recalling sandwiches, associated with the affected eggs, due to potential contamination of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and individuals with weakened immune systems.

Feb 3, 2012 - Greencore, USA is recalling approximately 550 pounds of egg salad sandwiches. The sandwiches contain eggs manufactured by Michael Foods Inc that are the subject of a previous recall due to possible contamination with Listeria Monocytogenes.

Feb 2, 2012 - Allison's Gourmet Kitchens was notified by their egg supplier, Michael Foods, Inc. that they are recalling numerous lots of their hard cooked eggs due to the potential for contamination by Listeria monocytogenes. Some of these eggs were introduced into our process to manufacture these effected products.

Feb 2, 2012 - Bedford Laboratories, today issues updated guidance on the following nationwide voluntary product recall originally initiated on December 20, 2011

Feb 2, 2012 - Wegmans Food Markets, Inc. is recalling hard-cooked eggs, as well as prepared foods that contain hard-cooked eggs, sold between January 23 and February 1, 2012 because the eggs 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 headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. 

Feb 2, 2012 - S&M USA ENTERPRISE is recalling ZHANG ZHOU BRAND TREMELLA because it may contain undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

Feb 2, 2012 - Advanced Animal Nutrition today announced a voluntary recall of its dry Dog Power Dog Food- due to aflatoxin levels that were detected above the acceptable limit. The affected products were manufactured between Jan. 4, 2011, and Nov. 18, 2011.

Feb 2, 2012 - W & International Import Inc. is recalling "Rely" Dried Yellow Croaker because the product was found to be un-eviscerated. The recalled "Rely" Dried Yellow Croaker was distributed nationwide in bulk cardboard boxes.

Feb 3, 2012 - This page contains links to all past Consumer Update Analytics web pages.

Jan 25, 2012 - FDA gives updated safety information on ADHD drugs and heart disease in adults, dietary supplements that could be contaminated with Salmonella, and a blood thinner that may lead to bleeding problems. Learn about these and other safety alerts at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucmXXXXXX.htm

Jan 12, 2012 - Learn how to report a bad reaction to a beauty, personal hygiene or makeup product. Click here to find out how to connect to this 30-minute webinar.

Jan 6, 2012 - Don't be fooled by unscrupulous people who offer hope through unapproved stem cell therapies for diseases or conditions for which few treatments exist.

Dec 28, 2011 - The Food and Drug Administration is taking steps to ensure that reusable medical devices, especially endoscopes, are properly cleaned and disinfected to reduce the risk of infection.

Dec 27, 2011 - FDA warns about a home massager that has caused a death, and gives updated safety information on ADHD drugs and heart disease in children, and TNF blocker drugs that have been linked to reports of cancer. Learn about these safety alerts and others: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm283962.htm

Dec 22, 2011 - FDA is urging consumers to examine the labels of liquid infant's acetaminophen to avoid giving the wrong dose as a less concentrated form of the popular medicine arrives in stores.

Dec 13, 2011 - Beware of ads that glamorize this surgery without giving the risks. Learn more at www.fda.gov/ForConsumers/ConsumerUpdates/ucm279301.htm

Dec 9, 2011 - FDA is enhancing its surveillance of arsenic in apple juice while remaining confident in the overall safety of this juice for consumers.

Dec 9, 2011 - The Food and Drug Administration (FDA) is building a coalition of public and private healthcare organizations to prevent a medical error - the surgical fire.

Dec 6, 2011 - The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) warn companies that the homeopathic HCG weight-loss products they sell are illegal and make unproven claims.

Dec 1, 2011 - FDA warns consumers about a potentially contaminated nasal spray, contact lenses that may cause eye injuries, an unapproved drug sold as a testosterone booster, and more.

Nov 28, 2011 - Learn how FDA handles the millions of shipments of FDA-regulated products imported into the U.S. each year. Click here to find out how to connect to this 30-minute webinar.

Nov 17, 2011 - The Great American Smokeout on Nov. 17 is an opportunity for smokers to make a plan to quit smoking. Or even to quit smoking just on that day.

Nov 15, 2011 - Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics

Nov 11, 2011 - Not all children with ADHD are overactive. Learn the other symptoms and what to do if you suspect your child may have this disorder.

Nov 9, 2011 - FDA has created a new website to help consumers protect themselves from fraudulent health products and schemes.

Nov 8, 2011 - Careless at-home disposal of needles, syringes and lancets is putting families and waste-disposal workers in danger.

Oct 31, 2011 - Every year thousands of children are hospitalized and some die after taking medicine not meant for them. FDA pharmacist Connie Jung explains in this video how you can prevent harm by locking your medicine up.

Oct 31, 2011 - Diarrhea lasting more than 24 hours can cause your child to become dangerously dehydrated. Learn the signs of dehydration, how to prevent it, and when to call the doctor.

Feb 13, 2012 - The U.S. Food and Drug Administration is requesting a budget of $4.5 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2013 budget – a 17 percent increase over the FDA enacted budget for FY 2012. Industry user fees would fund 98 percent of the proposed budget increase. The FY 2013 request covers the period from Oct. 1, 2012 through Sept 30, 2013.

Feb 13, 2012 - Accurate Set Inc., of Newark, N.J., and the company’s president and owner, Cornell L. Adams, have agreed to stop manufacturing and distributing medical devices as part of a consent decree of permanent injunction.

Feb 10, 2012 - The U.S Food and Drug Administration is warning dental and veterinary professionals to not purchase or use certain potentially unsafe hand-held dental X-ray units. The FDA is concerned that these devices may not be safe or effective and could expose the user and the patient to unnecessary and potentially harmful X-rays. The units, sold online by manufacturers outside the United States and directly shipped to U.S. customers, have not been reviewed by the FDA and do not meet FDA radiation safety requirements. (MB)

Feb 9, 2012 - The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.

Feb 1, 2012 - The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.

Jan 31, 2012 - The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.

Jan 31, 2012 - The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.

Jan 31, 2012 - The U.S. Food and Drug Administration is asking a federal court to prevent a New York cheese manufacturer from operating because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria.

Jan 30, 2012 - Today, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).

Jan 27, 2012 - The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.

Jan 25, 2012 - Generic drug manufacturer agrees to remedy deviations from the current good manufacturing practice requirements and to correct data integrity problems at numerous facilities

Jan 24, 2012 - A Maine food processing and storage company destroyed its cold smoked salmon product under the supervision of the U.S. Food and Drug Administration after inspectors found Listeria monocytogenes within the firm’s facility and on processing equipment

Jan 20, 2012 - Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn’s disease (CD).

Jan 17, 2012 - The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure. Methotrexate is a commonly used cancer chemotherapy drug normally eliminated from the body by the kidneys. However, patients receiving high doses of methotrexate may develop kidney failure.

Jan 13, 2012 - The U.S. Food and Drug Administration today expanded the approved usage for an endovascular graft manufactured by W.L. Gore and Associates Inc. to include treatment of life-threatening tears or ruptures of the aorta (thoracic aortic transection). (MB)

Jan 13, 2012 - The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients, FDA Commissioner Margaret A. Hamburg, M.D. said today. The recommendations were transmitted to Congress today by Health and Human Services Secretary Kathleen Sebelius.

Jan 4, 2012 - The U.S. Food and Drug Administration today issued an order that prohibits certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys effective April 5, 2012.

Dec 30, 2011 - Prevnar 13, a pneumococcal 13-valent conjugate vaccine, was approved today by the U.S. Food and Drug Administration for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.

Dec 29, 2011 - The U.S. Food and Drug Administration today approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products.

Dec 22, 2011 - The U.S. Food and Drug Administration announced today that a Chicago-area company has agreed to stop making its ready-to-eat sandwiches and produce after FDA investigators repeatedly found unsanitary conditions and bacterial contamination in the facility.