The U.S. Food and Drug Administration today expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis. The approval triples the number of rare gene mutations that the drug can now treat, expanding the indication from the treatment of 10 mutations, to 33. The agency based its decision, in part, on the results of laboratory testing, which it used in conjunction with evidence from earlier human clinical trials. The approach provides a pathway for adding additional, rare mutations of the disease, based on laboratory data.
All posts by admin
Global Garlic Inc. Recalls Queso Fresco/ Whole Milk Cheese Because Of Possible Health Risk
Global Garlic Inc. of Miami, Florida is recalling 227 units of Queso Fresco/ Whole Milk Cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.
FDA warns Americans about risk of inaccurate results from certain lead tests
The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States.
La Nica Products, Inc. Recalls Cheese Because of Possible Health Risk
La Nica Products, Inc. of Miami, FL is recalling six thousand pounds of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.
Read The Complete Story!
La Nica Products, Inc. Recalls Cheese Because of Possible Health Risk
La Nica Products, Inc. of Miami, FL is recalling six thousand pounds of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.
Read The Complete Story!
Italian Gluten Free Food Cl Issues Allergy Alert On Undeclared Egg In “Chef Luca’s Lasagna Al Forno – Baked Cheese Lasagna”
Italian Gluten Free Food CL of 1899 Bushwick Avenue, Merrick, NY 11566, is recalling its 15 ounce packages of “Chef Luca’s LASAGNA AL FORNO BAKED CHEESE LASAGNA” food because they may contain undeclared egg. People who have allergies to eggs run the risk of serious or life- threatening allergic reaction if they consume these products.
Read The Complete Story!
Italian Gluten Free Food Cl Issues Allergy Alert On Undeclared Egg In “Chef Luca’s Lasagna Al Forno – Baked Cheese Lasagna”
Italian Gluten Free Food CL of 1899 Bushwick Avenue, Merrick, NY 11566, is recalling its 15 ounce packages of “Chef Luca’s LASAGNA AL FORNO BAKED CHEESE LASAGNA” food because they may contain undeclared egg. People who have allergies to eggs run the risk of serious or life- threatening allergic reaction if they consume these products.
Read The Complete Story!
Green Chile Concepts, Llc Voluntarily Recalls Select Product Codes And Production Dates Of Green Chile Food Company Brand Burrito Products
Green Chile Concepts, LLC is voluntarily recalling certain Green Chile Food Company brand burritos sold frozen, refrigerated and/or served hot in certain convenience stores, vending machines, and retail locations nationwide because they may have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short- term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
The Horton Fruit Company, Inc. Issues Voluntary Recall of Fresh Spinach Because of Possible Health Risk
The Horton Fruit Co., Inc. (“Horton”) of Louisville, KY is voluntarily recalling select bags and containers of fresh spinach because it has the potential to be contaminated with Listeria monocytogenes. The company was alerted to the potential of contamination by their supplier partners, and conducting a subsequent internal investigation.
Allergy Alert Issued by Arabella Station Whole Foods Market for Undeclared Walnuts in Oatmeal Chocolate Chip Cookies
The Arabella Station Whole Foods Market store, located at 5600 Magazine Street in New Orleans, is voluntarily recalling packaged oatmeal chocolate chip cookies because the product contained tree nut allergens (walnuts) that were not listed on the product label. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reaction if they consume these products.