October 31, 2016
The International Company for Agricultural Production & Processing (ICAPP) is voluntarily recalling certain lots of its frozen strawberries out of an abundance of caution in response to a U.S. Food and Drug Administration (FDA) investigation of an outbreak of Hepatitis A. Read The Complete Story!
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October 28, 2016
The U.S. Food and Drug Administration today approved the Amplatzer PFO Occluder device. The PFO Occluder reduces the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart, called a patent foramen ovale (PFO), and then traveled […]
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October 27, 2016
Back to Nature Foods, LLC is voluntarily recalling four (4) products because those products contain chocolate purchased from a third party supplier which was found to contain undeclared Milk that is not listed as an ingredient on the label. Read The Complete Story!
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October 19, 2016
The U.S. Food and Drug Administration today granted accelerated approval to Lartruvo (olaratumab) with doxorubicin to treat adults with certain types of soft tissue sarcoma (STS), which are cancers that develop in muscles, fat, tendons or other soft tissues. Lartruvo is approved for use with the FDA-approved chemotherapy drug doxorubicin for the treatment of patients […]
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October 17, 2016
The U.S. Food and Drug Administration today announced that it has awarded 21 new clinical trial research grants totaling more than $23 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry with research spanning domestic […]
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October 13, 2016
Brownwood Farms of Williamsburg, MI is recalling approximately 15,000 total units of the listed products, because they contain undeclared soy or Yellow #5 food coloring. People who have an allergy or severe sensitivity to soy or Yellow #5 food coloring run the risk of serious or life-threatening allergic reaction, if they consume these products. Read […]
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October 13, 2016
Brownwood Farms of Williamsburg, MI is recalling approximately 15,000 total units of the listed products, because they contain undeclared soy or Yellow #5 food coloring. People who have an allergy or severe sensitivity to soy or Yellow #5 food coloring run the risk of serious or life-threatening allergic reaction, if they consume these products. Read […]
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October 4, 2016
Good Earth Egg Company, LLC of Bonne Terre, Missouri has announced a voluntary recall of its shell eggs because they 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. Healthy persons infected with […]
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September 30, 2016
Graceleigh, Inc. d/b/a Sammy’s Milk is recalling all lots of Sammy’s Milk Baby Food because of possible presence of Cronobacter, a bacteria that can cause severe and sometimes fatal blood infections or meningitis in infants and it may not provide adequate nutritional levels of iron. Read The Complete Story!
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September 30, 2016
The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession.
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September 30, 2016
Fresh Express Incorporated of Orlando, Florida, is voluntarily conducting a precautionary recall of 480 cases of 11 oz. Fresh Express American Salad with a Product Code of G264A12A and Use-By Date of October 5, due to possible exposure to undeclared allergens (egg, milk, wheat, anchovy). Fresh Express representatives are coordinating with retail stores to ensure […]
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September 29, 2016
Information security and the protection of industry and public health information are among the FDA’s highest priorities and we do not take lightly the recommendations provided by the GAO in its June 2016 report.
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September 28, 2016
McCain Foods USA, Inc. of Lisle, IL, today announced it is expanding its voluntarily recall of retail, frozen onion rings to include two (2) additional private label retail branded products due to the use of incorrect packaging that does not declare milk as one of the ingredients. People who have an allergy or severe sensitivity […]
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September 28, 2016
The U.S. Food and Drug Administration today approved Medtronic’s MiniMed 670G hybrid closed looped system, the first FDA-approved device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes.
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September 28, 2016
Koffee Kup Bakery, Inc. has voluntarily recalled approximately 99,000 packages of its bread products due to the possibility that there may be clear plastic pieces in some products. The product recall is limited to the bread products listed below and only those identified by the “use by” dates 9/30/16, 10/1/16, 10/2/16 or 10/3/16, which are […]
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September 27, 2016
Café Valley of Marion, Indiana is recalling 543 cases of Banana nut mini muffins labeled as Lemon poppy seed mini muffins, because they may contain undeclared walnuts. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reaction if they consume these products. Read The Complete Story!
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September 26, 2016
Mt Kisco Smokehouse of Mt Kisco, NY, is voluntarily recalling two types of smoked salmon because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Read The Complete Story!
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September 23, 2016
The U.S. Food and Drug Administration today approved three new indications for Ilaris (canakinumab). The new indications are for rare and serious auto-inflammatory diseases in adult and pediatric patients:
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September 23, 2016
The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.
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