Concertos in Chocolate of Boulder, Colorado is recalling 450 solid milk chocolate Santas. Because of possible mislabeling it may contain undeclared milk products.
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Category Archives: Food Safety News
Montana dietary supplement maker found in contempt of court
The U.S. Food and Drug Administration announced today that on Dec. 4, 2013, a Livingston, Mont., dietary supplement maker was found in civil contempt of court for repeatedly violating the terms of a consent decree of permanent injunction that resolved a 2010 civil case against the company and its owner.
FDA approves Anoro Ellipta to treat chronic obstructive pulmonary disease
The U.S. Food and Drug Administration today approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
FDA allows marketing of new stent for treating pseudocysts of the pancreas
The U.S. Food and Drug Administration today allowed marketing of the AXIOS Stent and Delivery System for treating pseudocysts (fluid and tissue filled cavities) that form in the pancreas and are next to the stomach or small intestine. This is the first stent that is specifically designed for drainage of a pancreatic pseudocyst by creating a new, temporary opening between the pancreas and the gastrointestinal tract.
FDA and European Medicines Agency launch generic drug application inspections initiative
The U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies.
FDA issues proposed rule to determine safety and effectiveness of antibacterial soaps
The U.S. Food and Drug Administration today issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.
FDA allows marketing of first device to relieve migraine headache pain
The U.S. Food and Drug Administration today allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS), the first device to relieve pain caused by migraine headaches that are preceded by an aura: a visual, sensory or motor disturbance immediately preceding the onset of a migraine attack.
Whole Foods Market Mid-Atlantic Region Recalls Spinach Dip Due to Undeclared Egg
Whole Foods Market Mid-Atlantic Region is recalling an organic creamy spinach dip because it contains eggs, an undeclared allergen.
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Health Matters America Inc. Issues an Allergy Alert on Undeclared Milk in Organic Traditions Brand Dark Chocolate Hazelnuts, Dark Chocolate Hazelnuts with Chili, Dark Chocolate Almonds, and Dark Chocolate Almonds with Chili.
HEALTH MATTERS AMERICA INC. of Cheektowaga, New York is recalling specific lots of ORGANIC TRADITIONS DARK CHOCOLATE HAZELNUTS, ORGANIC TRADITIONS DARK CHOCOLATE HAZELNUTS WITH CHILI, ORGANIC TRADITIONS DARK CHOCOLATE ALMONDS, and ORGANIC TRADITIONS DARK CHOCOLATE ALMONDS WITH CHILI because they were found to contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
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FDA approves first generic versions of antidepressant drug Cymbalta
The U.S. Food and Drug Administration today approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions.