Consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia).
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Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage.
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The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.
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The U.S. Food and Drug Administration is asking a federal court to prevent a New York cheese manufacturer from operating because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria.
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Today, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).
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Vitaflo USA has announced a voluntary recall of Renastart 14.11 oz (400g) cans, Batch Number 12832 (shown on underside of can), because some of the product shipped throughout the United States during the period December 29, 2011 through January 26, 2012 has been incorrectly labeled. Renastart is a powdered medical food used in the dietary management of pediatric renal disease, for patients one year and older in the United States.
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Johnson & Johnson Consumer Companies, Inc. is voluntarily recalling from retailers one lot of AVEENO® BABY CALMING COMFORT® LOTION (full product details below) in Alabama, Arkansas, Florida, Georgia, Kansas, Louisiana, Mississippi, Tennessee and Texas. This is not a consumer level recall and no action is required by consumers.
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Walgreen Co. is voluntarily recalling certain lots of 13-oz. Walgreens Chocolate-Covered Raisins because the packages may contain Walgreens Bridge Mix with peanut, almond and soy ingredients. The error occurred when Walgreens Bridge Mix was mistakenly packaged with the Walgreens Chocolate-Covered Raisin labeling.
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Several U.S. government-funded HIV/AIDS clinical research sites in Africa will join other collaborators in an ongoing clinical trial testing an investigational tuberculosis (TB) vaccine in infants at risk for TB infection. “We are pleased to be able to tap into our existing HIV/AIDS clinical research infrastructure to help test promising investigational vaccines against TB,” said NIAID Director Anthony S. Fauci, M.D. The sites are funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
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The National Institute on Minority Health and Health Disparities (NIMHD) announced today the appointment of M. Roy Wilson, M.D., M.S., an award-winning physician and academic administrator, as NIMH’s Deputy Director Strategic Scientific Planning and Program Coordination. NIMHD is part of the National Institutes of Health.
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