Today, the U.S. Food and Drug Administration announced it would pursue a strategic, new public health education campaign aimed at discouraging the use of e-cigarettes and other electronic nicotine delivery systems (ENDS) by kids. The agency plans to expand its “The Real Cost” public education campaign to include messaging to teens about the dangers of […]
Freshtex Produce of Alamo, TX is voluntarily recalling “Valery” brand Maradol Papayas grown and packed by Carica de Campeche, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected […]
Agroson’s LLC of Bronx, NY is recalling 2,483 boxes of Maradol Papaya Cavi Brand, grown and packed by Carica de Campeche, as a precaution because other brands that also buy from this farm have been tested positive for Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly […]
U.S. District Judge Robert J. Shelby entered a consent decree of permanent injunction yesterday between the United States and Isomeric Pharmacy Solutions of Salt Lake City, Utah, two of the company’s co-owners, William O. Richardson and Rachael S. Cruz, and chief operating officer Jeffery D. Brown.
The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype […]
Rugby® Laboratories of Livonia, MI is voluntarily recalling all lots within the expiry of Diocto Liquid and Diocto Syrup, (docusate sodium solutions) manufactured by PharmaTech, LLC of Davie, FL due to a risk of product contamination with Burkholderia cepacia. If a product contains B. cepacia, its use could result in infections in patients with compromised […]
The U.S. Food and Drug Administration today approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is a fixed-combination of chemotherapy drugs daunorubicin and cytarabine.
Amrita Health Foods is recalling a limited number of Amrita Bars 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 […]
Fairway ‘‘Like No Other Market’’® of New York, NY is voluntarily recalling Fairway brand Cookies Blondie, because the product may contain undeclared ingredient, walnuts. People who have an allergy or severe sensitivity to nuts run the risk of serious or life-threatening allergic reaction if they consume this product. Read The Complete Story!
Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.
Commonwealth Dairy of Brattleboro, VT is recalling Friendly Farms Key Lime Crunch Tilts because it may contain undeclared almond pieces. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if they consume these products.
The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD.
The AMPT Life, LLC is voluntarily recalling all lots of AMPT Coffee to the consumer level. FDA laboratory analysis confirmed the presence of Sildenafil and Tadalafil, the active ingredient in Viagra, an FDA-approved prescription drug for Erectile Dysfunction (ED). AMPT Coffee also contains undeclared milk.
The U.S. Food and Drug Administration today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene […]
Sacramento, California, Man of Steel is voluntarily recalling 175 lots of Man of Steel 1 and Man of Steel 2, 4000mg at the retail level. The products have been found to contained undeclared Sildenafil.
Vibrant Health Products, a family-owned bakery in Abbotsford, B.C., Canada, has voluntarily recalled one lot of liveGfree Gluten Free Classic Soft White Hamburger Buns due to a packaging error. As a result, this product may contain undeclared egg.
ICU Medical, Inc. is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container.
Bush Brothers & Company® Recalls Certain Baked Beans in 28 Ounce Cans Due to a Can Seam Issue
The U.S. Food and Drug Administration today announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The goal […]