General Mills is voluntarily recalling about 1.8 million boxes of gluten-free original and Honey Nut Cheerios because of the possible presence of wheat.
Jim Murphy, senior vice president of General Mills’ cereal division, said he was “embarrassed and truly sorry” for an incident that allowed wheat flour to be introduced into the gluten-free oat flour system at a production facility in Lodi, California, the Washington Post reports. Continue reading
The U.S. Food and Drug Administration (FDA) is ordering duodenoscope manufacturers to study how the devices are cleaned. The safety studies are prompted by a series of antibiotic-resistant bacterial infection outbreaks in the United States linked to contaminated scopes. The makers of the specialized gastrointestinal scopes, which are all based in Japan and have affiliates in the United States, are Olympus American, Fuji Medical Systems and Hoya Corp., LA Times reports.
The scope makers must submit plans to study how well hospital staff are complying to instructions for cleaning and disinfecting the devices in between uses. The FDA’s goal is for these studies to shed light on the superbug outbreaks. This year, there were two outbreaks linked to duodenoscopes at Los Angeles hospitals. Officials from both hospitals say the scopes were cleaned according to manufacturers’ instructions. Continue reading
In a safety alert issued on October 5, the Food and Drug Administration (FDA) noted recent reports of reduced leaflet motion in some bioprosthetic aortic valves, including both SAVR (surgical aortic valve replacement) and TAVR (transaortic valve replacement) devices.
Most cases of reduced leaflet motion were discovered by advanced imaging studies in patients without symptoms of abnormal bioprosthetic valve function. Further, these studies have shown that in valves with reduced motion of one or more individual leaflets, there was acceptable forward blood flow through the valve opening without evidence of stenosis (narrowing), according to the FDA. Continue reading
Rabbi Sholom Doyber Levitansky was arrested by Santa Monica, California police last week on felony charges of sexual abuse of a child.
The police are seeking further information and are trying to locate any additional victims, the Santa Monica Daily Press (SMDP) reports. Continue reading
California Parents Sue GlaxoSmithKline over Child’s Heart Defect Allegedly Caused by Zofran Taken During Pregnancy
Alameda County, California, parents have filed a lawsuit against GlaxoSmithKline (GSK) for a heart defect their daughter suffered allegedly as a result of the mother being prescribed Zofran (ondansetron) while pregnant.
This medication is used to prevent nausea and vomiting caused by chemotherapy and radiation therapy and is also used to prevent and treat nausea and vomiting after surgery. It works by blocking one of the body’s natural substances (serotonin) that causes vomiting, according to WebMD. Continue reading
A bicycle recall is being issued due to a problem with front wheel disc brakes. According to the U.S. Consumer Product Safety Commission, the recall involves 13 manufacturers and affects 1.3 million bikes. Popular brands such as Giant, Cannondale and Specialized are affected by the recall. The CPSC advises consumers to “stop using the bicycles immediately and contact the recalling company for free installation of a new quick release on the front wheel,”
The issue involves the open quick release lever on the bicycle’s front wheel hub, which can catch onto the front disc brake rotor; this may cause the front wheel to stop or separate from the bike and injure the rider. The CPSC says three incidents have been reported, including one injury. The recalled bikes were sold from 1998 to this year. Roughly 1.3 million units were sold in American and over 250,000 were sold in Canada and Mexico. Continue reading
Automaker Fiat Chrysler under-reported a “significant” number of deaths, injuries and legal claims that it was obliged to reveal to regulators, according to the National Highway Traffic Safety Administration (NHTSA).
The federal regulator announced the under-reporting after Fiat Chrysler said it had discovered “deficiencies” in its system for reporting defects under the Tread Act, a law that specifies the information car makers must submit to regulators, CNBC reports. Continue reading
Health Canada, Canada’s health regulatory agency, has updated the label information for the multiple sclerosis drug Gilenya (fingolimod) to include stronger safety warnings on the risk of skin cancer and the rare brain infection progressive multifocal leukoencephalopathy (PML), which can be fatal.
Gilenya, a prescription drug, is used in the treatment of relapsing-remitting multiple sclerosis (MS) to reduce the frequency of attacks (relapses) and delay the progression of physical disability. Gilenya is used specifically when other MS treatments have not been effective or cannot be tolerated, Health Canada explains. Continue reading
Chewbeads Inc. has recalled more than 45,000 pacifier clips in the United States and Canada because they may pose a risk of choking for babies. According to the Consumer Product Safety Commission, the New York-based company had received seven reports of beads detaching from the pacifier clips, but no injuries can been reported thus far.
Fox News reports that five styles of Chewbeads Bay pacifier clip holders are affected by the recall, including those with shapes of a butterfly, a dinosaur, a heart, a sheriff’s badge, a white baseball with red stitching and a major league baseball team logo. The pacifier clip holders are called “Where’s the Pacifier?” and contain eight multi-colored beads threaded on a satin ribbon. The beaded ribbon is attached to a pacifier on one end and a plastic D-ring on the other; the product is about 6 inches long in total. Recalled clips have one of the following codes on the back: 3/31/14, 08/08/14, 12/01/14, 14/30/09, 15/02/09, 25/04/14. Continue reading
As part of an internal restructuring related to its $49.9 billion merger with Covidien, Medtronic will pay a one-time tax charge of $500 million so that it can bring $9.8 billion in overseas cash to the United States.
This move is the result of the tax inversion deal that relocated Medtronic from Minnesota to Ireland, where corporate taxes are much lower. Medtronic could use the extra cash to fund more acquisitions, Med Device Online reports. Continue reading