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.
Category Archives: Food Safety News
H-E-B Issues Voluntary Recall H-E-B hamburger and hotdog buns and Hill Country Fare hotdog buns recalled for quality issues.
H-E-B, committed to the quality of its products, is issuing a voluntary recall for H-E-B brand hamburger and hotdog buns and Hill Country Fare hotdog buns due to the possible presence of foreign material that might impact the quality of the product. A terry cloth glove used for handling hot pans could have broken up in the dough, resulting in a potential choking hazard.
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OtisMed Corporation former CEO sentenced for shipping adulterated knee replacement cutting guides
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.
FDA approves new antiplatelet drug used during heart procedure
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.
United Salad Co. Recalls Champ’s Sliced Crimini Mushrooms Because of Possible Health Risk
United Salad Co., the distributor of Portland, Oregon, is initiating a voluntary recall of Champ’s Sliced Crimini Mushrooms, product of Canada, because it has 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.
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FDA allows marketing of new device to help the blind process visual signals via their tongues
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 sold online
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.
FDA approves SAPIEN 3 THV artificial heart valve
The U.S. Food and Drug Administration today approved the SAPIEN 3 Transcatheter Heart Valve (THV) for patients with a narrowing in the heart’s aortic valve, called aortic valve stenosis. Aortic valve stenosis obstructs blood flow from the heart into the aorta, which can lead to serious heart problems. The SAPIEN 3 THV is approved for patients with aortic valve stenosis who are inoperable or at high risk for death or complications associated with open-heart surgery.
The FDA takes step to remove artificial trans fats in processed foods
Based on a thorough review of the scientific evidence, the U.S. Food and Drug Administration today finalized its determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. Food manufacturers will have three years to remove PHOs from products.
FDA approves brain implant to help reduce Parkinson’s disease and essential tremor symptoms
The U.S. Food and Drug Administration today approved the Brio Neurostimulation System, an implantable deep brain stimulation device to help reduce the symptoms of Parkinson’s disease and essential tremor, a movement disorder that is one of the most common causes of tremors. The Brio Neurostimulation System can help some patients when medication alone may not provide adequate relief from symptoms such as walking difficulties, balance problems, and tremors.