On April 22, 2015, the United States District Court for the Northern District of Illinois entered a consent decree of permanent injunction against Wholesome Soy Products Inc., of Chicago, Illinois, owner Julia Trinh, and manager Paul Trinh, following multiple findings of contaminated food and environmental samples by the U.S. Food and Drug Administration.
Category Archives: Food Safety News
FDA approves first-of-its-kind corneal implant to improve near vision in certain patients
The U.S. Food and Drug Administration today approved the KAMRA inlay, a device implanted in the cornea of one eye (the clear, front surface) to improve near vision in certain patients with presbyopia. It is the first implantable device for correction of near vision in patients who have not had cataract surgery.
FDA approves first generic Copaxone to treat multiple sclerosis
The U.S. Food and Drug Administration today approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS).
U.S. Marshals seize unapproved drugs from Florida distributor
At the request of the U.S. Food and Drug Administration and the U.S. Attorney for the Southern District of Florida, U.S. Marshals seized unapproved prescription drug products valued at over $1,500,000 from Stratus Pharmaceuticals, Inc., of Miami, Florida. Stratus Pharmaceuticals marketed and distributed unapproved prescription drug products that were manufactured by Sonar Products, Inc., of Carlstadt, New Jersey.
FDA approves Corlanor to treat heart failure
The U.S. Food and Drug Administration today approved Corlanor (ivabradine) to reduce hospitalization from worsening heart failure.
FDA approves Corlanor to treat heart failure
The U.S. Food and Drug Administration today approved Corlanor (ivabradine) to reduce hospitalization from worsening heart failure.
FDA warns consumers not to use muscle growth product called Tri-Methyl Xtreme
The U.S. Food and Drug administration is warning consumers to stop using a dietary supplement for muscle growth linked to serious liver injury.
Blue Bell Creameries Expands Recall of Products Produced in Broken Arrow, Oklahoma Due to Possible Health Risk
Blue Bell Creameries is expanding its recall of products that were produced in the Broken Arrow, Okla., plant to include Banana Pudding Ice Cream pints which tested positive for Listeria monocytogenes, and additional products manufactured on the same line. These items have the potential to be young children, frail or elderly people, and others with weakened immune systems.
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FDA approves breath test to aid in diagnosis of delayed gastric emptying
The U.S. Food and Drug Administration today approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test to aid in the diagnosis of delayed gastric emptying, known as gastroparesis.
Henry’s Farm Inc Recalls Soybean Sprouts Due to Possible Health Risk
Henry’s Farm Inc. of Woodford, VA is recalling all packages of soybean sprouts because they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals with weakened immune systems. Although healthy individuals may suffer only short term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
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