Category Archives: Food & Drug Recalls

Boulder Dog Food Company, L.L.C. Voluntarily Recalls Ten Bags of Chicken Sprinkles, 3 oz. With A “Best By” Date of “05/04/16” Due to Possible Salmonella Health Risk

Boulder Dog Food Company, L.L.C. is voluntarily recalling the Chicken Sprinkles (3 oz.) with a “Best By” date of “05/04/16”, a Lot Number of “998”, and a UPC Code of 899883001231 (the “Product”), because the Product has the potential of being contaminated with Salmonella. Salmonella can affect animals eating the Product, and there is risk to humans who handle the Product, especially if the handler does not thoroughly wash his or her hands after having contact with the Product or any surfaces exposed to the Product.

The Raymond-Hadley Corporation Issues Allergy Alert on Undeclared Sulfites in Phoebe Mote Blanco White Corn Semoule De Mais Blanc

The Raymond-Hadley Corporation, 89 Tompkins Street, Spencer, NY 14883 is recalling PHOEBE MOTE BLANCO WHITE CORN SEMOULE DE MAIS BLANC, PESO NETO 396.9 g, NET WEIGHT 14oz. PHOEBE MOTE PELADO BLANCO 50lb. PHOEBE MOTE PELADO BLANCO PESO NETO 1530g, NET WEIGHT 54oz. PHOEBE MOTE BLANCO PEELED WHITE CORN PESO NETO 1814g, NET WEIGHT 4lb. 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.

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.

Philips Response To ResMed Update On Phase IV SERVE-HF Study Of Adaptive Servo-Ventilation (ASV) Therapy In Central Sleep Apnea And Chronic Heart Failure

On May 15, 2015, Respironics, Inc., a Philips business, provided the following response to ResMed’s Update on Phase IV SERVE-HF Study of Adaptive Servo-Ventilation (ASV) Therapy in Central Sleep Apnea and Chronic Heart Failure. On May 13, 2015, ResMed issued a press release and a related Urgent Field Safety Notice.