The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for previously treated patients with Waldenström’s macroglobulinemia (WM), a rare form of cancer that begins in the body’s immune system. The drug received a breakthrough therapy designation for this use.
Category Archives: Food & Drug Recalls
FDA takes steps to improve reliability of automated external defibrillators
The U.S. Food and Drug Administration announced today that it will strengthen its review of automated external defibrillators (AEDs) to help improve the quality and reliability of these devices.
Dairy Recall
Elevated Ice Cream Co. advises our customers that our dairy, Snoqualmie Gourmet Ice Cream Dairy in Maltby, has issued a voluntary recall of all dairy products processed in their plant. Elevated Ice Cream uses dairy products processed by Snoqualmie Gourmet, therefore we are asking all of our customers not to eat any ice cream which may be in your home freezers.
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Lime Green Grocer, Inc. Issues Allergy Alert on Undeclared Soy in the Thai Delight Burrito
Lime Green Grocer, Inc. of Seattle, Washington is recalling 783 individually wrapped Thai Delight Burritos, because it may contain undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product.
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Probar LLC Recalls Probar Base Frosted Peanut Butter Bars Due to Possible Presence of Undeclared Milk Allergen
PROBAR LLC of Salt Lake City, UT has initiated a voluntary recall of its PROBAR Base Frosted Peanut Butter Bars due to the possible presence of an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of a serious allergic reaction if they consume this product. No other PROBAR products are affected.
FDA approves first generic esomeprazole
The U.S. Food and Drug Administration today approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach.
Comunicado Actualizado: Quesería Bendita LLC Retira Quesos Frescos Y Crema Agria Debido a Posibles Riesgos Para la Salud
Quesería Bendita LLC, de Yakima, Washington, está retirando todos los lotes de productos de queso panela, queso fresco, requesón, queso Cotija y crema agria que incluyen TODAS las fechas de caducidad debido a la posibilidad de que estén contaminados con la bacteria Listeria monocytogenes, un organismo que puede causar infecciones graves y a veces hasta mortales en infantes, personas mayores o con una salud delicada y otras personas con un sistema inmunológico debilitado. Aunque las personas sanas quizás sólo sufran síntomas a corto plazo, tales como fiebre alta, dolor de cabeza intenso, rigidez, náuseas, dolor abdominal y diarrea, la infección por listeria puede causar abortos y mortinatos (nacimiento muerto del bebé) entre las mujeres embarazadas.
Dr. Robert Califf named FDA Deputy Commissioner for Medical Products and Tobacco
U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D., today appointed Robert Califf, M.D., a recognized global leader in cardiology, clinical research, and medical economics, as FDA Deputy Commissioner for Medical Products and Tobacco.
Korean Food Co. Issues Allergy Alert on Undeclared Shrimp in Mak Kimchi
Korean Food Co. in Irving, Texas is recalling Mak kimchi in 32oz and half gallon glass jars, because it may contain undeclared shellfish (shrimp). People who have an allergy or severe sensitivity to shellfish (shrimp) run the risk of serious or life-threatening allergic reaction if they consume these products.
FDA approves Natpara to control low blood calcium levels in patients with hypoparathyroidism
The U.S. Food and Drug Administration today approved Natpara (parathyroid horomone) to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 people in the United States.