Archive for February, 2010

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Johnny’s Fine Foods Recalls Johnny’s French Dip Powdered Au Jus Because of Possible Health Risk

Johnny’s Fine Foods of Tacoma, Wash., Johnny’s Fine Foods is recalling French Dip Powdered Au Jus in 6oz bottles and French Dip Powdered Au Jus in 1.1oz foil packets, because it has the potential to be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems…

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International Collaboration: FDA and European Medicines Agency Agree to Accept a Single Orphan Drug Designation Annual Report

In recognition of World Rare Disease Day, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions.

FDA Update on the Investigation into the Salmonella Montevideo Outbreak – February 26, 2010

The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.

FDA Approves Therapy to Treat Gaucher Disease

The U.S. Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.

OneTouch SureStep Test Strips (LifeScan): Recall

Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.

U.S. Attorney News Release: Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety

U.S. Attorney News release: Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety Problems to FDA

StatSpin Express 4 Centrifuges Model 510: Class I Recall

Rotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms.

FDA Update on the Investigation into the Salmonella Montevideo Outbreak – February 25, 2010

The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.

Safe Use of Flea and Tick Products in Pets

Pet owners should take certain precautions to use these products safely on their pets.

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U.S. Attorney News Release: Medical Technician Sentenced to 30 Years

Statement by U.S. attorney David Gaouette regarding the sentencing of Kristen Parker