Remarks from FDA Commissioner Scott Gottlieb, M.D. on Fiscal Year 2019 budget request for FDA
FDA Commissioner Scott Gottlieb, M.D. remarks to the U.S. House Committee on Appropriations on the FDA’s Fiscal Year 2019 budget
Archive for the ‘Food & Drug Recalls’ category
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 […]
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 […]
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 […]
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 […]
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.
Urgent: Voluntary Product Recall of Vuse Vibe Power Units
R.J. Reynolds Vapor Company has voluntarily initiated a nationwide safety recall of all Vuse Vibe power units. The Company initiated the recall after receiving consumer complaints about malfunctioning batteries, which may cause the power unit to overheat and create a fire risk. The Company notified the U.S. Food and Drug Administration regarding the issue and […]
Rose Acre Farms Recalls Shell Eggs Due to Possible Health Risk
Through an abundance of caution Rose Acre Farms of Seymour, Indiana is voluntarily recalling 206,749,248 eggs because they have the potential to be contaminated with Salmonella Braenderup, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals infected with Salmonella […]
Seacrest Foods Recalls l’Explorateur Soft Ripened Cheese Due to Possible Health Risk
Seacrest Foods International, Inc. of Lynn, MA is voluntarily recalling 29 cases of Formagere 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, pregnant women and others with […]
‘Rhino 69 Extreme 50000’ Recalled due to Presence of Active Ingredient ‘Tadalafil’
AMA Wholesale Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. Tadalafil is an active ingredient in a FDA-approved prescription drug that is used for erectile dysfunction.
La FDA toma medidas para proteger a los consumidores de los suplementos alimenticios que contienen niveles peligrosamente altos de cafeína altamente concentrada o pura
: El día de hoy, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) tomó una medida importante para proteger mejor a los consumidores de los peligros de los productos de cafeína altamente concentrada y pura.
FDA takes step to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine
Today, the U.S. Food and Drug Administration took an important step to better protect consumers from the dangers of highly concentrated and pure caffeine products.
Guixens Food Group Issues Allergy Alert on Undeclared Sulfites in La Marinera Brand Dried Yellow Potatoes
Guixens Food Group, Inc., of Miami, FL, is voluntarily recalling its ten-ounce packages of La Marinera Brand Dried Yellow Potatoes because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.
FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests
The FDA today finalized two guidances to drive the efficient development of a novel technology that scans a person’s DNA to diagnose genetic diseases, which are usually hereditary, and guide medical treatments.
Cookwell & Company Issues Allergy Alert for Undeclared Soy, Wheat and Fish Allergen in Charred Tomato & Basil Sauce with a “Best By” Date of “10 Nov 18”
Cookwell & Company Is voluntarily recalling potentially up to 6,522 units of its Four J Charred Tomato & Basil Sauce because it may contain undeclared soy, wheat and fish. People who have an allergy or severe sensitivity to these allergens may run the risk of a serious or life-threatening allergic reaction if they consume this […]