The U.S. Food and Drug Administration today ordered the three manufacturers of duodenoscopes marketed in the U.S. to conduct postmarket surveillance studies to better understand how the devices are reprocessed in real-world settings.
Category Archives: Food & Drug Recalls
Texas Star Nut and Food Co., Inc. Voluntarily Recalls Natural Macadamia Nuts and Simply Raw Trail Mix Due To Possible Salmonella Contamination
Texas Star Nut and Food Co., Inc. VOLUNTARILY RECALLS Nature’s Eats, Natural Macadamia Nuts 6oz and Southern Grove, Simply Raw Trail Mix 8oz. The above products have 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.
Dean Foods of Decatur, Ind. Issues Allergy Alert On Undeclared Milk in Sunkist Frozen Mango Fruit Sorbet Bars
Dean Foods of Decatur, Indiana, is voluntarily recalling Sunkist brand Frozen Mango Fruit Sorbet Bars because these products may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
FDA approves Keytruda for advanced non-small cell lung cancer
The U.S. Food and Drug Administration today granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors.
Wyandot Inc. Issues Allergy Alert on Undeclared Milk in Yellow Round Tortillas
Wyandot Inc. is recalling select packages of Yellow Round Tortillas due to potential milk contamination. We were notified by a customer that they found cheese curls, a milk containing product, mixed in the bag with the tortilla chips.
Salix Animal Health, LLC, Announces Voluntary Recall of One Lot of "Good ‘N’ Fun – Beefhide Chicken Sticks" Dog Treats Due to Possible Salmonella Contamination
Salix Animal Health, LLC today announced it has initiated a voluntary recall of one lot of “Good ‘n’ Fun – Beefhide Chicken Sticks” because it may have the potential to be contaminated with Salmonella. Salmonella can affect animals eating the product and there is risk to humans from handling contaminated products.
United TC Issues Allergy Alert on Undeclared Sulfites in Golden Raisins
United TC of Dayton, NJ is recalling Basma Golden Raisins, 16 oz. and bulk cartons of Golden Raisins, 30 Lb. because they 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 these products.
Fatima Brothers Issues Alert On Undeclared Sulfites In Shad Raisins
Fatima Brothers Inc. of Maspeth, NY is recalling its 7 oz. and 14 oz. packages of SHAD RAISINS because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.
Fatima Brothers Issues Alert On Undeclared Sulfites In “Shad Raisins�
Fatima Brothers Inc. of Maspeth, NY is recalling its 7 oz. and 14 oz. packages of “SHAD RAISINS” because they contained undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.
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FDA permits marketing of new laser-based hearing aid with potential for broad sound amplification
The U.S. Food and Drug Administration today allowed marketing of a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. The combination of laser light pulses and a custom-fit device component that comes in direct contact with the eardrum is designed to use the patient’s own eardrum as a speaker and enables amplification over a wider range of frequencies for some hearing impaired persons. The EarLens Contact Hearing Device (CHD) is indicated for use by adults with mild to severe sensorineural hearing impairment.