Archive for October, 2011
Emporium Packaging & Spice Co. of Temple, Texas is recalling all Ponchatrain Sauce Mix because it may contain undeclared milk and soy. People who have an allergy or severe sensitivity to milk or soy, run the risk of serious or life-threatening allergic reaction if they consume these products.
Tags: FDA Recalls
The U.S. Food and Drug Administration today announced the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI).
The centers, which will be located at the University of Maryland and Georgetown University, will focus on strengthening science and training needed to modernize and improve the ways drugs and medical devices are reviewed and evaluated, a major focus within the FDA.
Tags: fda press release
Days before Halloween, federal regulators have a word of caution about an old fashioned candy treat—licorice.
Tags: Consumer Health Alerts
In a recent study, Xigris failed to show a survival benefit for patients with severe sepsis and septic shock.
Tags: MedWatch Safety Alerts
American Egg Products of Blackshear, Georgia, is recalling five pound cartons of frozen egg product, Lot #272-1, because they may 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 Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
Tags: FDA Recalls
Fresh & Easy Neighborhood Market Inc., is voluntarily recalling fresh bagged Washed Spinach 12oz, with the Enjoy by date of OCT 16 sold under the f&e™ label. The recall notification is being issued out of an abundance of caution based on a random sample test, conducted on behalf of the Food & Drug Administration (FDA).
Tags: food safety
The U.S. Food and Drug Administration today approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tablets) to treat schizophrenia and bipolar disorder.
Tags: fda press release
District Court’s Rulings Focus on Record Keeping and Illegal Tissue Residues
Tags: pet product recalls
UPDATED 10/24/2011. Updated study data. Healthcare professionals should continue to monitor patients for neuropsychiatric symptoms.
Tags: MedWatch Safety Alerts
On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended to treat a disease or condition that affects fewer than 200,000 people in the United States, it was granted orphan drug designation by the FDA.
Tags: fda press release