The U.S. Food and Drug Administration published a final rule today that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.
FDA issues final rule on changes to pregnancy and lactation labeling information for prescription drug and biological products
The U.S. Food and Drug Administration published a final rule today that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.
Whole Foods Market West Hartford, Bishops Corner and Glastonbury Recall Tarte Aux Pommes Due to Undeclared Almonds
Three Connecticut Whole Foods Market locations are recalling “Tarte Aux Pommes” produced and sold in West Hartford Center, Bishops Corner and Glastonbury, Connecticut due to an undeclared almonds. The 6 inch tarte was mislabeled as a “Tarte Aux Pomme 10in” and has a “best by” date between November 20 and December 1, 2014.
The six inch tarte contained almonds as an ingredient, which was not declared on the label.
Whole Foods Market’s Southwest Region recalls Vegan Pumpkin Pie due to Undeclared Walnuts
Whole Foods Market is recalling “Vegan pumpkin pie” produced and sold in the Southwest Region, which includes TX, OK, LA, AR, due to undeclared walnuts.
Read The Complete Story!
FDA allows marketing of non-invasive device to help evaluate heart blood flow
The U.S. Food and Drug Administration today allowed marketing of the HeartFlow FFR-CT software, which permits health care professionals to non-invasively evaluate blood flow in the coronary arteries of patients showing signs and symptoms of coronary artery disease.
Select Containers of Private Selection Denali Extreme Moose Tracks Ice Cream Recalled for Undeclared Allergen
The Kroger Co. (NYSE: KR) said today it is recalling select containers of Private Selection Denali Extreme Moose Tracks Ice Cream sold in 13 states because it may contain peanuts not listed on the label. Item Description:
Private Selection Denali Extreme Moose Tracks Ice Cream sold in 48-ounce containers with a “sell by” date of April 16, 2015 under the following UPC Code: 11110-00456.
CONMED Corporation Issues a Voluntary Device Correction for PadPro and R2 Multi-function Defibrillation Electrodes
CONMED Corporation announces that it has notified customers of a Voluntary Urgent Device Correction for certain PadPro and R2 Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillator Units. These electrodes will not connect with Philips FR3 or FRx AED units.
Henry’s Farm Inc. Recalls Soybean Sprouts Due To Possible Health Risk
Henry’s Farm Inc. of Woodford, VA is recalling all packages of Soybean Sprouts because they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals 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.
URGENT PRODUCT RECALL NOTICE
Acme Smoked Fish Corporation of Brooklyn, NY is voluntarily recalling 564 pounds of its Imported (Product of Denmark) Acme 4oz. (113g) vacuum packs of Smoked Nova Salmon with lot code of L.05122014 because it may be contaminated with Listeria monocytogenes. This organism can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems.
Read The Complete Story!
Flying Cow Creamery Voluntarily Recalls Yogurt
Flying Cow Creamery is voluntarily recalling one lot of whole milk yogurt due to a faulty time and temperature recording during pasteurization. Pasteurization heats milk to eliminate all illness-causing bacteria such as Listeria monocytogenes and Salmonella.
Read The Complete Story!