FDA Commissioner Scott Gottlieb, M.D. remarks to the U.S. House Committee on Appropriations on the FDA’s Fiscal Year 2019 budget
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FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia
FDA approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare form of rickets.
Statement by Dr. Susan Mayne on FDA efforts to reduce consumer exposure to arsenic in rice
One way FDA oversees food safety is through monitoring of contaminants in food, such as arsenic, assessing potential exposure and taking steps to reduce exposure
World’s Best Cheese Recalls l’Explorateur Soft Ripened Cheese Due to Possible Health Risk
World’s Best Cheeses of Armonk, NY is recalling 22 cases of Formagerie de la Brie brand, l’Explorateur soft ripened cheese because it has 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.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to enhance and modernize the FDA’s approach to medical device safety and innovation
The FDA is releasing the Medical Device Safety Action Plan that outlines our vision for how FDA can continue to enhance our programs and processes to assure the safety of medical devices
Cal-Maine Foods, Inc. Announces Voluntary Shell Egg Recall Due to Possible Health Risk
Cal-Maine Foods, Inc. (NASDAQ: CALM) today announced the Company was notified after the close of business on April 13, 2018, by Rose Acre Farms of Seymour, Indiana, of a voluntary egg recall. The eggs involved in the recall have the potential to be contaminated with Salmonella Braenderup and were distributed from Rose Acre Farms’ Hyde County, North Carolina, facility from January 11, 2018, through April 12, 2018.
Epic Products, LLC, Issues Voluntary Nationwide Recall of All Lots of Euphoric Capsules Due to Presence of Undeclared Sildenafil and Tadalafil
Overland Park, KS, Epic Products, LLC is voluntarily recalling all lots of Euphoric capsules, packaged in 1 count blister cards, 3 count bottles, and 12 count bottles to the consumer level. FDA analysis found samples of Euphoric to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterase 5-inhibitors (PDE-5 inhibitors), used to treat male erectile dysfunction (ED). The presence of sildenafil and tadalafil in Euphoric renders it an unapproved drug for which safety and efficacy have not been established and, therefore subject to recall.
FDA orders mandatory recall for kratom products due to risk of salmonella
MANDATORY RECALL ordered for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC
Vitakraft Sun Seed Recalls of Sunseed Vita Prima Sugar Glider Food Due to Possible Salmonella Health Risk
Vitakraft Sun Seed Inc. of Weston, OH, is voluntarily recalling one lot of Sunseed Vita Prima Exotics Sugar Glider Formula because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
K9 Natural Ltd Voluntarily Recalls K9 Natural Frozen Chicken Feast Raw Pet Food 2.2lb And 11lb Bags Because Of Possible Listeria Monocytogenes
K9 Natural Ltd is voluntarily recalling four batches of the K9 Natural Frozen Chicken Feast 2.2lb and 11lb bags that was imported into the US market in June 2017 because they have the potential to be contaminated with Listeria Monocytogenes.