FDA reaches agreement with automatic external defibrillator manufacturer over quality control issues
FDA reaches agreement with automatic external defibrillator manufacturer over quality control issues
Archive for the ‘Food Safety News’ category
Rucker’s Makin’ Batch Candies Issues Food Recall of Dark Chocolate Coffee Beans, Dark Chocolate Cranberries and Dark Chocolate Peanuts – Because of Possible Health Risk, Due to Undeclared Milk Allergen
Rucker’s Makin’ Batch Candies, Inc. of Bridgeport, IL is voluntarily recalling the specific code dates listed below of The Toothsome Chocolate Emporium Dark Chocolate Coffee Beans, due to an undeclared milk allergen. People who have an allergy or severe sensitivity to milk allergen run the risk of serious or life threatening allergic reaction if they […]
Allergy Alert Issued in Five Northern California Whole Foods Market Stores for Undeclared Walnuts in Pumpkin Drop Cookies
Five Whole Foods Market stores in Northern California are voluntarily recalling frosted Pumpkin Drop cookies because the products contained tree nut allergens (walnuts) that were not listed on the product label. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reactions if they consume these products. […]
FDA approves new treatment for adults with mantle cell lymphoma
The U.S. Food and Drug Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.
FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections
The U.S. Food and Drug Administration has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable are those located in: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new strategies for addressing the crisis of opioid addiction through innovation in packaging, storage and disposal
Statement by FDA Commissioner Gottlieb on new strategies for addressing the opioid addiction crisis.
Statement from Susan Mayne, Ph.D., on proposal to revoke health claim that soy protein reduces risk of heart disease
Statement from Susan Mayne, Ph.D., on proposal to revoke health claim that soy protein reduces risk of heart disease
Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s important efforts to address the opioid crisis
Today the Administration took a historic step to direct additional resources to help address the staggering human and economic toll created by the epidemic of opioid addiction.
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance medical device innovation and help patients gain faster access to beneficial technologies
Enabling patients and providers to have efficient access to new and innovative medical products that meet the FDA’s gold standard for safety and effectiveness is a core part of our mission. We’re advancing these goals as part of the Medical Innovation Access Plan that I announced earlier this year. While we’ve unveiled parts of that […]
Paragon Foods Recalls 1.7 Ounce Bagged Broccoli Florets Because of Possible Health Risk
Paragon Wholesale Foods Corp., of Warrendale, PA, is recalling several lots of 1.7 ounce Broccoli Florets in response to a nationwide recall by one of its suppliers, Mann Packing (Salinas, CA) because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, […]
FDA warns Magellan Diagnostics of significant violations of the law as part of investigation into lead testing issues
Today the U.S. Food and Drug Administration issued a warning letter to Magellan Diagnostics Inc. for several violations of federal law, including marketing significantly modified versions of two of its blood lead testing systems without the FDA’s required clearance or approval and failing to submit medical device reports to the FDA after becoming aware of […]
Statement by FDA Commissioner Scott Gottlieb, M.D. on medical device manufacturing recovery in Puerto Rico
Statement by FDA Commissioner Scott Gottlieb, M.D. on medical device manufacturing recovery in Puerto Rico
FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma
The U.S. Food and Drug Administration today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second […]
Stonyfield Announces Nationwide Voluntary Recall of Specific Code Date of Strawberry O’Soy Soy Yogurt
Organic yogurt maker, Stonyfield, is voluntarily recalling a specific code date of its O’Soy Strawberry soy yogurt because it may contain an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product. Read The Complete Story!
Great Lakes Cheese Announces Recall Of American Accent Shredded Imitation Mozzarella Cheese Product
Great Lakes Cheese Co. Inc. today announced the recall of 60 packages of American Accent Shredded Imitation Mozzarella Cheese with a best by date of JUN 8 2018 because of undeclared milk allergens on its label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction […]
Aunt Beth’s Cookies Allergy Alert On Undeclared Nuts In Cookies
Aunt Beth’s Cookies in Mishawaka, IN is voluntarily recalling certain baked cookies sold between January 1, 2017 and September 28, 2017 because they may contain traces of undeclared peanut or tree-nut allergens. People who have an allergy or severe sensitivity to peanuts and tree nuts run the risk of serious or life-threatening allergic reaction if […]
FDA clears new robotically-assisted surgical device for adult patients
Today, the U.S. Food and Drug Administration cleared the Senhance System, a new robotically-assisted surgical device (RASD) that can help facilitate minimally invasive surgery.
California dietary supplement maker, Custompax prohibited from manufacturing
A California dietary supplement manufacturer recently was ordered by a federal court to stop selling its products until the company comes into compliance with the U.S. Food and Drug Administration’s dietary supplement manufacturing regulations and other requirements listed in a consent decree.