The U.S. Food and Drug Administration today announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses.
Giant Eagle Voluntary Recall of Irish Soda Bread Due to Undeclared Milk Allergen
Giant Eagle brand Irish Soda Bread, baked and sold inside Giant Eagle supermarkets between February 24 and March 11, has been voluntarily recalled by Giant Eagle today due to an undeclared milk allergen. This creates the potential for serious health consequences if consumed by those with milk allergies.
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T. Up Trading, Inc. Issues Allergy Alert on Undeclared Milk in Corn Bba
T. Up Trading, Inc. of Secaucus, NJ is recalling Korean snack named Corn Bba, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk related ingredient run the risk of serious or life-threatening allergic reaction if they consume these products.
Hospira Issues a Voluntary Nationwide Recall of One Lot of Lactated Ringer’s Irrigation Due to Mold Contamination
Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary recall of one lot of Lactated Ringer’s Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report of several dark, fibrous particulates floating within the solution of the primary container. The particulate was confirmed as a common non-toxic, non-invasive mold, Aspergillus kanagawaensis.
Federal judge enters consent decree against Specialty Compounding LLC
U.S. District Judge Lee Yeakel entered a consent decree of permanent injunction on March 10, 2015 between the United States and Specialty Compounding LLC, of Cedar Park, Texas, and the company’s co-owners, Raymond L. Solano, III and William L. Swail. According to the complaint filed with the consent decree, Specialty Compounding manufactured purportedly sterile injectable drug products that tested positive for bacterial contamination. The U.S. Department of Justice brought the action on behalf of the U.S. Food and Drug Administration.
Ultra ZX LABS, L.L.C. Issues Voluntary Nationwide Recall of Ultra ZX Since It Contains Undeclared Sibutramine and Phenolphthalein
UltaZx, Labs, L.L.C. is voluntarily recalling “UltraZx” weight loss supplements. This product has been found to contain undeclared Sibutramine and phenolphthalein.
FDA approves first therapy for high-risk neuroblastoma
The U.S. Food and Drug Administration today approved Unituxin (dinutuximab) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children.
FDA approves CPR devices that may increase chance of surviving cardiac arrest
The U.S. Food and Drug Administration today approved the ResQCPR System, a system of two devices for first responders to use while performing cardiopulmonary resuscitation (CPR) on people whose hearts stop beating (cardiac arrest). The devices may improve the patient’s chances of surviving cardiac arrest.
FDA approves CPR devices that may increase chance of surviving cardiac arrest
The U.S. Food and Drug Administration today approved the ResQCPR System, a system of two devices for first responders to use while performing cardiopulmonary resuscitation (CPR) on people whose hearts stop beating (cardiac arrest). The devices may improve the patient’s chances of surviving cardiac arrest.
FDA approves new antifungal drug Cresemba
The U.S. Food and Drug Administration today approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections.