Archive for January, 2012


FDA Recall Alerts: Vitaflo USA Announces Nationwide Voluntary Recall of Renastart 14.11 oz (400g) Cans Batch Number 12832 Due to Possible Health Risk

Vitaflo USA has announced a voluntary recall of Renastart 14.11 oz (400g) cans, Batch Number 12832 (shown on underside of can), because some of the product shipped throughout the United States during the period December 29, 2011 through January 26, 2012 has been incorrectly labeled. Renastart is a powdered medical food used in the dietary [...]

Read More...

FDA Press Releases: FDA approves Kalydeco to treat rare form of cystic fibrosis

The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene. Food and Drug Administration–Press Releases

Read More...

FDA Recall Alerts: Walgreen Co. Voluntarily Recalls Certain Lots of 13 Oz. Chocolate-Covered Raisins As Product May Contain Peanuts, Almonds, Soy Due to Packaging Error

Walgreen Co. is voluntarily recalling certain lots of 13-oz. Walgreens Chocolate-Covered Raisins because the packages may contain Walgreens Bridge Mix with peanut, almond and soy ingredients. The error occurred when Walgreens Bridge Mix was mistakenly packaged with the Walgreens Chocolate-Covered Raisin labeling. Food and Drug Administration–Recalls/Safety Alerts

Read More...

FDA Mediation Watch: Treanda (bendamustine HCL): Recall – Particulate Matter in Vial

Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage. MedWatch Safety Alert RSS Feed

Read More...

FDA Press Releases: FDA approves new treatment for most common type of skin cancer

Today, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has [...]

Read More...