The U.S. Food and Drug Administration today approved the first DNA test to help health care professionals gauge the progress of anti-viral treatment in solid organ transplant patients undergoing cytomegalovirus (CMV) antiviral therapy.
FDA prompts companies to remove certain unapproved oxycodone products from market
The U.S. Food and Drug Administration today issued a Federal Register notice instructing companies to stop manufacturing and distributing certain unapproved drugs that contain oxycodone. The notice is part of the FDA’s Unapproved Drugs Initiative to remove unapproved new drugs from the market.
BEDFORD LABORATORIES™ ISSUES NATIONWIDE VOLUNTARY HOSPITAL/USER‐LEVEL RECALL OF LEUCOVORIN CALCIUM INJECTION
This voluntary recall is being conducted due to the discovery of visible crystalline particulate matter in a small number of vials
within the lots listed above. The particulate matter has been identified as active drug substance and not foreign material or
contamination.
URGENT: Recalling Due to Undeclared Eggs
Fruiti Pops, Inc. is recalling 178 dozen Fruiti Pops 4 ounce Classic Coconut frozen dessert bars because they may contain egg yolk. People who have an allergy or severe sensitivity to eggs run the risk of serious and life threatening allergic reaction if they consume these products.
FDA approves first over-the-counter home use HIV test kit
The U.S. Food and Drug Administration today approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
FDA proposes unique device identification system for medical devices
FDA proposes that most medical devices distributed in the United States carry a unique device identifier or UDI.
Voluntary Recall of LabDie and Mazuri Feed Products
PMI Nutrition International has initiated a voluntary recall of four varieties of the LabDiet® and Mazuri® feed products listed below, due to the potential for an elevated vitamin D level in these products. Elevated vitamin D levels can be harmful to animals if fed for extended periods.
CareFusion Provides Update On Voluntary Recall Of Select AirLife™ Respiratory Products
CareFusion issued the following update regarding its voluntary recall of its AirLife™ Infant Breathing Circuit. The FDA has classified this action as a Class 1 recall.
***UPDATED CONSUMER ALERT*** Listeria Contamination in Certain Mexicali Cheese Corp. Products
New York State Agriculture Commissioner Darrel Aubertine today warned consumers in the metropolitan New York area, including Queens, the Bronx, and Brooklyn, to not consume certain cheese products made by Mexicali Cheese Corp. located at 91-52 87th Street in Woodhaven, New York due to possible Listeria contamination.
ITO EN Asks Hawaii Customers of Aloha Maid Coconut Water with Pineapple to Return Product to Store
ITO EN USA requests that Hawaii customers of its canned Aloha Maid Coconut Water with Pineapple purchased since May 16, 2012 return the products to stores for a refund. The drink can is stamped on underside with the code IHMAY0913 and the UPC Code is 8-35146-00818-3.