The FDA approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.
Category Archives: Food & Drug Recalls
Allergen Alert: Kitchen Cravings Strawberry and Mixed Berry Parfaits with Trace Tree Nuts
Kwik Trip, Inc. located in La Crosse, WI is recalling Kitchen Cravings Strawberry and Mixed Berry Parfaits in an 8.25 oz. cup because they may contain undeclared traces of cashews or almonds
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Achdut Recalls Multiple Brands of "Tahini" Because It May Be Contaminated with Salmonella
Achdut LTD. of Ariel, Israel, is recalling its Tahini products of all packages and
sizes produced on the following dates: April 7th to May 21st 2018, because it
may 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.
Statement from FDA Commissioner Scott Gottlieb, M.D., on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway
FDA Commissioner statement on modernizing the 510(k) pathway by creating policies that rely on newer predicates with modern characteristics related to their safety and performance
Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry
Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India.
The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes.
Sunshine Mills, Inc. Issues Voluntary Recall of Dry Dog Food Due to Potentially Elevated Levels of Vitamin D
Sunshine Mills, Inc. is issuing a voluntary recall of select products of Evolve Puppy, Sportsman’s Pride Large Breed Puppy and Triumph Chicken and Rice Dog Food (reference below) due to potentially elevated levels of Vitamin D.
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Statement by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals, including nickel and lead, found in some kratom products
FDA scientists tested 26 separate kratom products and found lead and nickel at levels not considered safe for human consumption
FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients
FDA issues a warning to consumers to beware of and avoid certain male enhancement products that may be dangerous to their health
Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation
Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation
FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor
The FDA granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker).