The U.S. Food and Drug Administration announced that Sungwon Inc of Columbia, a Columbia, Md., corporation, and the company’s president, Sang Ja Lee, have signed a consent decree of permanent injunction.
Category Archives: Food Safety News
FDA provides updated safety data on silicone gel-filled breast implants
The U.S. Food and Drug Administration released a report today updating the clinical and scientific information for silicone gel-filled breast implants, including preliminary safety data from studies conducted by the manufacturers as a condition of their November 2006 approval.
HHS RELEASE: FDA unveils final cigarette warning labels
The U.S. Food and Drug Administration (FDA) today unveiled the nine graphic health warnings required to appear on every pack of cigarettes sold in the United States and in every cigarette advertisement. This bold measure will help prevent children from smoking, encourage adults who do to quit, and ensure every American understands the dangers of smoking.
FDA issues draft guidance for early version of an artificial pancreas system
The U.S. Food and Drug Administration today issued draft guidance that will help advance the development and approval of an artificial pancreas system to treat type 1 diabetes in the United States.
FDA unveils new global strategy to help ensure safety and quality of imported products
The U.S. Food and Drug Administration today unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the “Pathway to Global Product Safety and Quality.”
FDA examines ways to improve consumer understanding of prescription drug ads
Findings from three studies conducted by the U.S. Food and Drug Administration confirm that the way information is conveyed and displayed in printed drug advertising affects consumer understanding of prescription medications.
FDA approves first generic versions of the antibiotic levofloxacin to treat certain infections
The U.S. Food and Drug Administration today approved the first generic versions of Levaquin (levofloxacin), an antibiotic approved to treat certain infections in people ages 18 and older.
Levofloxacin is used to treat mild, moderate, or severe bacterial infections of the skin, sinuses, kidneys, bladder, and prostate caused by specific germs. It also is used to treat certain bacterial infections that cause bronchitis or pneumonia, and to treat those exposed to inhalational anthrax.
Earth Fare Recall on Frozen Spicy Bean Burgers in Akron, Ohio Due To Possible Health Risks
Earth Fare, Fletcher, NC is recalling its frozen Earth Fare Spicy Bean Burger with UPC code 8-78602-00518 and lot codes #05311 and #06711 because of a potential Salmonella contamination. No other Earth Fare Veggie Burger products were affected.
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Manufacturer for Publix Brand Caesar Salad Dressing Issues an Allergen Alert for Undeclared Fish, Soy and Gluten
– The manufacturer of Publix Caesar Salad Dressing, Ken’s Foods, Inc. is recalling a limited number of 16oz Publix Caesar Salad Dressing bottles because it may contain undeclared fish, gluten and soy allergens. People who have an allergy or severe sensitivity to fish, soy and gluten run the risk of serious or life-threatening allergic reaction if they consume these products.
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Bariatric Advantage (Division of Catalina Lifesciences) Issues Allergy Alert on Undeclared Milk Protein in Chewable Multi Formula High in Vitamins A, D, E & K (Chocolate Mint Truffle)
Bariatric Advantage of Irvine, California is recalling individual sample packs, and 60 & 180 tablet bottles, of its Chewable Multi Formula in the chocolate mint truffle flavor, because it may contain milk protein not listed on the label. People who have an allergy or severe sensitivity to milk may run the risk of serious or life-threatening allergic reaction if they consume these products.
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