The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.
Category Archives: Food & Drug Recalls
FDA and industry reach agreement in principle on medical device user fees
The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.
President Global Corporation Announces Bin-Bin Snow Rice Crackers and Bin-Bin Rice Crackers Recall For Undeclared Egg
President Global Corp., Buena Park, CA is recalling all codes of Bin-Bin Snow Rice Cracker net weight 5.3oz (150g) and Bin-Bin Rice Crackers net weight 15.8oz (450g) because of undeclared egg allergens.
Pfizer Announces Voluntary Nationwide Recall of Lo/Ovral-28 and Norgestrel/Ethinyl Estradiol Tablets Due to Possibility of Inexact Tablet Counts or Out of Sequence Tablets
Pfizer Inc. announced today that it has voluntarily recalled 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol)Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic)for customers in the U.S. market.
How Sweet It Is Fudge and Candy Company, East Lansing, Michigan, Allergy Alert On Undeclared Milk Allergens In Products "Peanut Butter Buckeye" and “Peanut Butter Smoothie� Date Code 01/23/2012 and Earlier
How Sweet It Is Fudge and Candy Company Inc. is recalling / correcting its 32 count packages of “Peanut Butter Buckeye� and “Peanut Butter Smoothie� because they do contain undeclared milk allergens. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
Gemini Food Corporation and Tong Enterprises Announces Bin-Bin Snow Rice Crackers and Bin-Bin Rice Crackers Recall For Undeclared Egg
Gemini Food Corporation of City of Industry, CA and Tong Enterprises of Hayward, CA are recalling all codes of Bin-Bin Snow Rice Cracker net weight 5.3oz (150g) and Bin-Bin Rice Crackers net weight 15.8oz (450g) because of undeclared egg allergens. People who have an allergy or severe sensitivity to eggs, run the risk of suffering serious or life-threatening reactions if they consume this product.
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.
FDA takes action against New York cheese manufacturer
The U.S. Food and Drug Administration is asking a federal court to prevent a New York cheese manufacturer from operating because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria.
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 management of pediatric renal disease, for patients one year and older in the United States.
AVEENO BABY CALMING COMFORT LOTION
Johnson & Johnson Consumer Companies, Inc. is voluntarily recalling from retailers one lot of AVEENO® BABY CALMING COMFORT® LOTION (full product details below) in Alabama, Arkansas, Florida, Georgia, Kansas, Louisiana, Mississippi, Tennessee and Texas. This is not a consumer level recall and no action is required by consumers.