Category Archives: Food & Drug Recalls

FURTHER EXPANDED Recall Period of Certain Sunflower Kernel Products Due to Possible Contamination by Listeria Monocytogenes

Acting out of an abundance of caution, SunOpta has decided to further expand its voluntary recall of certain sunflower kernel products due to 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.

Meadow Gold Dairy in Boise Conducts Voluntary Recall of Whipping Cream and Half and Half Because of Possible Health Risk

The Meadow Gold Dairy plant in Boise is voluntarily recalling Meadow Gold brand Old Style Whipping Cream and Meadow Gold DairyPure brand Whipping Cream and Half and Half due to insufficient pasteurization. It is possible that pathogens present in raw milk, including Salmonella, Campylobacter, Listeria, and/or E. coli, may have survived and, if ingested, could cause serious or life threatening issues.

Statement from FDA Commissioner Robert Califf, M.D. on the release of the final individual patient expanded access form

Today, the U.S. Food and Drug Administration finalized its efforts to streamline the process used by physicians to request expanded access, often called “compassionate use,” to investigational drugs and biologics for their patients. As a physician, I understand the importance of being able to access investigational treatments for a patient when there are no other options to treat their serious disease or condition.

Frontera Foods Issues Allergy Alert for Undeclared Soy Allergen in Original Taco Skillet Sauce with a "Best By" Date of "13 Apr 17"

Due to a distributor’s loss of control, Frontera Foods of Chicago, Illinois is expanding their recall to an additional 1,314 (8 oz.) packages of its Frontera Texas Original Taco Skillet Sauce because it contains undeclared soy. People who have an allergy or severe sensitivity to soy may run the risk of a serious or life�threatening allergic reaction if they consume this product.

FDA approves new diagnostic imaging agent to detect rare neuroendocrine tumors

The U.S. Food and Drug Administration today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs).

FDA approves new diagnostic imaging agent to detect rare neuroendocrine tumors

The U.S. Food and Drug Administration today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs).

FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer

The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients. Such mutations are present in approximately 10-20 percent of non-small cell lung cancers (NSCLC).

FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer

The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients. Such mutations are present in approximately 10-20 percent of non-small cell lung cancers (NSCLC).