The U.S. Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Exondys 51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with DMD.
FDA permits marketing of balloon device to treat persistent Eustachian tube dysfunction
The U.S. Food and Drug Administration today permitted marketing of a device that uses a small balloon to treat persistent Eustachian tube dysfunction (ETD), a condition in which pressure, pain or clogged or muffled sensations occur in the ear.
SM Fish Corp Recalls Select Ossie’s Ready to Eat Salads Because of Possible Health Risk
SM Fish Corp. of Far Rockaway, NY, is voluntarily recalling OSSIE’S brand ready-to-eat salads 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.
FDA protects kids from illegal sales of e-cigarettes, e-liquids and cigars
The U.S. Food and Drug Administration announced today it has taken action against 55 tobacco retailers by issuing the first warning letters for selling newly regulated tobacco products, such as e-cigarettes, e-liquids and cigars, to minors. These actions come about a month after the FDA began enforcing new federal regulations making it illegal nationwide to sell e-cigarettes, cigars, hookah tobacco, and other newly regulated tobacco products to anyone under age 18 in person and online, and requiring retailers to check photo ID of anyone under age 27, among other restrictions.
Virtus Pharmaceuticals Opco II, LLC Issues Voluntary Nationwide Recall of Hyoscyamine sulfate Due to Superpotent and Subpotent Results
Virtus Pharmaceuticals Opco II, LLC (Virtus) is voluntarily recalling seven batches of Hyoscyamine sulfate (0.125mg) listed in the table below, to the consumer level which include the tablet, sublingual, and orally disintegrating
tablet form. This recall is being initiated due to both superpotent and subpotent test results. All of these batches were manufactured by Pharmatech LLC for
distribution by Virtus throughout the United States and Puerto Rico.
Drew’s, LLC Issues Allergy Alert on Undeclared Milk and Egg in One Lot of Field Day Organic Ranch Dressing
Drew’s, LLC of Chester, VT is voluntarily recalling one lot code of Field Day Organic Ranch Dressing due to product mislabeling that has resulted in an undeclared milk and egg allergen. Consumers who have severe allergies to milk and/or egg run the risk of serious or life- threatening allergic reaction if they consume this product.
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New Seasons Market Issues Allergy Alert on Undeclared Peanuts in Creamy Almond Butter
New Seasons Market of Portland, Oregon, has initiated a voluntary recall of its New Seasons Market 16oz. Creamy Almond Butter because it may contain undeclared peanuts.
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FDA approves VisuMax Femtosecond Laser to surgically treat nearsightedness
The U.S. Food and Drug Administration today approved the VisuMax Femtosecond Laser for the small incision lenticule extraction (SMILE) procedure to reduce or eliminate nearsightedness in certain patients 22 years of age or older.
Shearer’s Foods, LLC Issues Allergy Alert On Undeclared Soy And Milk In No Salt Added Kettle Cooked Potato Chips
Shearer’s Foods, LLC of Massillon, OH is recalling Meijer brand 8.5 ounce packages of No Salt Added Kettle Cooked Potato Chips because they may contain undeclared soy and milk. People who have allergies to soy and/or milk run the risk of serious or life-threatening allergic reaction if they consume these products.
Publix Recalls Apple Coffee Cakes (Foreign Matter-Metal)
Publix Super Markets of Lakeland, Florida, is issuing a voluntary recall for Apple Coffee Cakes due to the possible presence of small metal shavings. The Apple Coffee Cakes were sold at Publix bakery departments in Georgia, South Carolina, Alabama, Tennessee, North Carolina and the following counties in Florida: Alachua, Charlotte, Citrus, Collier, DeSoto, Hernando, Highlands, Hillsborough, Lee, Manatee, Marion, Pasco, Pinellas, Polk and Sarasota.