FDA provides update on ongoing efforts to mitigate impact of saline shortages and monitor other critical products during flu season
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Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products
FDA, USDA announce formal agreement to bolster coordination and collaboration
FDA Commissioner Dr. Scott Gottlieb and USDA Secretary Perdue launched an effort today to increase collaboration, efficiency and effectiveness, and provide clarity to food producers.
Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel® Due to Rare But Serious and Reversible Adverse Events While Seeking FDA’s Cooperation to Restore Access for Patients with Medical Necessity
Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA’s request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel.
Panera Bread Preemptively Recalls All 2 oz. and 8 oz. Cream Cheese Products
While there have been no reported illnesses, out of an abundance of caution, Panera Bread is conducting a nationwide preemptive, voluntary recall of all 2 oz. and 8 oz. cream cheese products sold in its U.S. bakery-cafes. This recall was initiated after samples of one variety of 2 oz. cream cheese from a single production day showed a positive result for the presence of Listeria monocytogenes. Tests on cream cheese samples manufactured both before and after the production run in question have all come back negative.
FDA approves new treatment for certain digestive tract cancers
FDA approves first radioactive drug for a certain type of digestive tract cancer called GEP-NETs
Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s strengthened commitments to humane and judicious animal research and the termination of a nicotine study
FDA strengthens commitments to humane and judicious animal research and the termination of a nicotine study
Bulletproof 360, Inc. Issues Allergy Alert on Undeclared Milk in Collagen Protein Dietary Supplement
Out of an abundance of caution, Bulletproof 360, Inc. is voluntarily recalling one lot #1017088 of Bulletproof Collagen Protein dietary supplement due to undeclared milk. 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.
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National Frozen Foods Corporation Recalls Frozen Green Beans and Frozen Mixed Vegetables Because of Possible Health Risk
National Frozen Foods Corporation (NFFC) is voluntarily recalling a limited quantity of Not-Ready-To Eat Individually Quick Frozen (IQF) green beans and IQF mixed vegetables because they have 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.
FDA, FTC warn companies for selling illegal, unapproved opioid cessation products using deceptive claims
FDA and FTC issued joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal