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FDA Requests Recall of Xiadafil VIP Tabs
submitted by hocket 102 days ago (via fda.gov)
The U.S. Food and Drug Administration today requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects.
 
0 Comments - More Info - Bury   Topic: Food
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FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream
submitted by hocket 107 days ago (via fda.gov)
The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants.
 
0 Comments - More Info - Bury   Topic: Food
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New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care
submitted by hocket 108 days ago (via hhs.gov)
HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care.
 
0 Comments - More Info - Bury   Topic: Food
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FDA Approves Entereg to Help Restore Bowel Function Following Surgery
submitted by hocket 109 days ago (via fda.gov)
The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses.
 
0 Comments - More Info - Bury   Topic: Food
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FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.
submitted by hocket 113 days ago (via fda.gov)
The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products
 
0 Comments - More Info - Bury   Topic: Food
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FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled
submitted by hocket 113 days ago (via fda.gov)
The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007.
 
0 Comments - More Info - Bury   Topic: Food
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FDA Takes Action against Cream Cheese Companies, Executives
submitted by hocket 114 days ago (via fda.gov)
The U.S. Food and Drug Administration today announced the shut down of cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary, LFI Enterprises, Inc., both Illinois companies, until they are found compliant with food-safety laws.
 
0 Comments - More Info - Bury   Topic: Food
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Manufacturer Removes Remaining Stocks of Trasylol
submitted by hocket 115 days ago (via fda.gov)
Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician’s stock. The FDA will work with Bayer to ensure a smooth and complete process.
 
0 Comments - More Info - Bury   Topic: Food
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FDA Approves New Formulation of Coagulation Therapy
submitted by hocket 120 days ago (via fda.gov)
he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years.
 
0 Comments - More Info - Bury   Topic: Food
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FDA Approves First Generic Ropinirole
submitted by hocket 120 days ago (via fda.gov)
The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.
 
0 Comments - More Info - Bury   Topic: Food





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