Statement by FDA Commissioner Scott Gottlieb, M.D. on Baxter manufacturing recovery in Puerto Rico
UPDATE: Greencore USA, LLC Recalls Egg Salad Sandwiches, Ham Salad Sandwiches, and Seafood Stuffing Because of Possible Health Risk
Greencore, USA, LLC is voluntarily recalling egg salad sandwiches, ham salad sandwiches, and seafood stuffing as listed below. The products are being recalled because Listeria monocytogenes was found in environmental sampling conducted by FDA.
FDA clears first 7T magnetic resonance imaging device
Today, the U.S. Food and Drug Administration cleared the first seven tesla (7T) magnetic resonance imaging (MRI) device, more than doubling the static magnetic field strength available for use in the United States. The Magentom Terra is the first 7T MRI system cleared for clinical use in the United States.
La Terra Fina Recalls 10 oz. Spinach Artichoke & Parmesan Dip & Spread Due to Mislabeling and Undeclared Allergen
La Terra Fina is voluntarily recalling its 10 oz. containers of Spinach Artichoke & Parmesan Dip & Spread with the date of BEST BY NOV-01-2017 due to undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume this product.
Statement by FDA Commissioner Scott Gottlieb, M.D. on new steps by FDA to advance patient engagement in the agency’s regulatory work
The Food and Drug Administration is hosting a pioneering event today: the first meeting of the Patient Engagement Advisory Committee or PEAC. It’s a significant step forward in the FDA’s efforts to broaden its engagement with patients – and to deepen the involvement of patients in our regulatory activities.
General Mills Issues Voluntary Recall of Cascadian Farm Organic Cinnamon Raisin Granola Cereal
General Mills is voluntarily recalling two days of production of Cascadian Farm Organic Cinnamon Raisin Granola cereal because of an undeclared allergen. There have been no reports of illness.
Great American Deli Issues Allergy Alert On Undeclared Egg And Soy In Premium Chicken Salad Wheatberry Sandwich
Great American Deli of Ooltewah, Tennessee is recalling 816 Premium Chicken Salad Wheatberry Sandwich Lot Number 17 198 because they have the wrong ingredient statement and contain undeclared eggs and soy. People who have an allergy or severe sensitivity to eggs or soy run the risk of serious or life-threatening allergic reaction if they consume these products.
Whole Foods Market Issues Nationwide Allergy Alert on Undeclared Peanuts in 365 Everyday Value Organic Raisin Bran
Whole Foods Market stores is voluntarily recalling 365 Everyday Value Organic Raisin Bran because the product contains undeclared peanuts that were not listed on the product label. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
FDA approves implantable device to treat moderate to severe central sleep apnea
The U.S. Food and Drug Administration today approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea. The Remedē System is an implantable device that stimulates a nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate breathing.
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s continued assistance following the natural disaster in Puerto Rico
FDA continues extensive efforts to provide direct assistance to the residents of Puerto Rico following Hurricanes Irma and Maria, and is taking new steps to mitigate the impact of these twin disasters on the island’s vibrant medical product manufacturing sector. Our top priority is the people of Puerto Rico.