June 29, 2016
The U.S. Food and Drug Administration today cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to Carbapenem antibiotics. Carbapenem antibiotics are widely used in hospitals to treat severe infections. These resistant organisms are commonly referred to as […]
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June 29, 2016
The U.S. Food and Drug Administration today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. It is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract […]
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June 29, 2016
The U.S. Food and Drug Administration today approved the Raindrop Near Vision Inlay, a device implanted in the cornea (the clear, front surface) of one eye to improve near vision in certain patients with presbyopia. It is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract […]
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June 29, 2016
The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in topical consumer antiseptic rubs (including hand sanitizers) marketed over-the-counter (OTC). The FDA’s request for more data is intended to help the agency ensure that regular use of these […]
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June 29, 2016
The FDA is honored to be an integral part of the Vice President’s National Cancer Moonshot Initiative (“Cancer Moonshot”), which calls on the agency to leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics and devices to create the Oncology Center of Excellence (OCE). The OCE will expedite the development […]
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June 28, 2016
The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a […]
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June 28, 2016
The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin. Epclusa is a fixed-dose combination tablet containing sofosbuvir, a […]
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June 28, 2016
The U.S. District Court for the Eastern District of California entered a consent decree of permanent injunction on Friday, June 24, 2016, between the U.S. Food and Drug Administration and Wa Heng Dou-Fu & Soy Sauce Corporation requiring the business to immediately cease manufacturing and distributing food until it comes into compliance with federal food […]
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June 28, 2016
The U.S. District Court for the Eastern District of California entered a consent decree of permanent injunction on Friday, June 24, 2016, between the U.S. Food and Drug Administration and Wa Heng Dou-Fu & Soy Sauce Corporation requiring the business to immediately cease manufacturing and distributing food until it comes into compliance with federal food […]
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June 24, 2016
The Father’s Table of Sanford, Florida, is voluntarily recalling 2,099 cases of cheesecakes sold by Gordon Food Service through retail and food service outlets under the GFS label as a result of a recall by one of The Father’s Table’s flour suppliers, Grain Craft. Read The Complete Story!
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June 23, 2016
Mondelēz Global LLC announced today a nationwide voluntary recall in the United States of the Honey Maid Teddy Grahams Cinnamon Cubs Graham Snacks sold only in Foodservice channels (not supermarkets). This recall is being conducted out of an abundance of caution following notification of a wheat flour recall by Grain Craft, a third-party flour supplier […]
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June 23, 2016
Mondelēz Global LLC announced today a nationwide voluntary recall in the United States of the Honey Maid Teddy Grahams Cinnamon Cubs Graham Snacks sold only in Foodservice channels (not supermarkets). This recall is being conducted out of an abundance of caution following notification of a wheat flour recall by Grain Craft, a third-party flour supplier […]
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June 23, 2016
Radagast Pet Food, Inc. (Portland, OR) has announced a voluntary recall of four lots of frozen Rad Cat Raw Diet products, sold in 8oz., 16oz., and 24oz. tubs, and free 1oz sample cups, due to the potential to be contaminated with Salmonella and/or Listeria monocytogenes. Salmonella and Listeria monocytogenes can affect animals eating the products […]
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June 23, 2016
Michael’s® Naturopathic Programs of San Antonio Texas is recalling certain lots of the dietary supplement Cholesterol Metabolism Factors™, because it may contain undeclared milk (in the form of calcium caseinate) and soy. People who have an allergy or severe sensitivity to milk and soy run the risk of serious or life-threatening allergic reaction if they […]
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June 21, 2016
Dutch Treat Foods, Inc., of Zeeland, MI, is voluntarily recalling 3087 pounds of Sweet Pea Pasta Salad due to one ingredient in the product being recalled by one of its suppliers. The product is being recalled due to the potential of being contaminated with listeria monocytogenes, an organism which can cause serious and sometimes fatal […]
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June 15, 2016
Sinosharp Import & Export Co., Ltd of Ridgewood, NY, is recalling its 13.74 oz and 2.2 lbs packages of “Chocolate Flavored Cookies” because this product contains undeclared milk allergens. Consumers who are allergic to milk may run the risk of serious or life-threatening allergic reactions if they consume this product. Read The Complete Story!
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June 14, 2016
The U.S. Food and Drug Administration today approved a new obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal.
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June 14, 2016
The U.S. Food and Drug Administration today approved a new obesity treatment device that uses a surgically-placed tube to drain a portion of the stomach contents after every meal.
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June 13, 2016
Kellogg Company (NYSE: K) today announced that it is voluntarily recalling certain varieties and limited dates of production of Mother’s, Keebler, Kellogg’s Special K brownies, Murray and Famous Amos snacks and cookies because they may contain undeclared peanut residue. Kellogg initiated the recall after its supplier, Grain Craft, recalled wheat flour that has the potential […]
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