Sunburst Superfoods of Tuckahoe, NY, is recalling Sunburst SUPERFOODS Organic Raw Carob Powder sold from March 12, 2014 through July 28th, 2014, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. […]
The U.S. Food and Drug Administration today announced the approval of Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than 8 years of age. In addition, the Risk Evaluation and Mitigation Strategy (REMS) known as the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program is being eliminated.
Out of an abundance of caution, Wawona Packing Company of Cutler, California is expanding its voluntary recall from July 19, 2014, of whole white and yellow peaches, white and yellow nectarines, plums and pluots due to the potential of the products being contaminated with Listeria monocytogenes. Read The Complete Story!
The U.S. Food and Drug Administration today approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes.
California Department of Public Health (CDPH) Director and State Health Officer Dr. Ron Chapman warned consumers today not to eat VR Green Farms jarred food products because they may have been improperly produced, making them susceptible to contamination with Clostridium botulinum. Read The Complete Story!
Today, the U.S. Food and Drug Administration approved Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema that are experiencing airflow obstruction. Striverdi Respimat can be used once daily over a long period of time.
Today, the U.S. Food and Drug Administration took important steps to ensure that certain tests used by health care professionals to help diagnose and treat patients provide accurate, consistent and reliable results.
Starway Incorporated, located at 137 Grattan Street, Brooklyn, NY, 11237, is recalling Peony Mark Brand Roasted and Salted Pumpkin Seeds because the product contains undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life threatening allergic reactions if they consume this product. Read The Complete Story!
Each year, thousands of Americans are diagnosed with some form of skin cancer. The Surgeon General’s Call to Action to prevent skin cancer is important especially during these hot summer months when many of us spend extra time in the sun.
The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use.
The U.S. Food and Drug Administration and the government of Mexico’s National Service for Agro-Alimentary Public Health, Safety and Quality (SENASICA) and Federal Commission for the Protection from Sanitary Risks (COFEPRIS) signed a statement of intent forming a partnership to promote the safety of fresh and minimally processed agricultural products.
Whole Foods Market has recalled made-in-store items prepared with organic and conventional stone fruit, including peaches, nectarines, and plums from Wawona Packing Co. because of possible contamination with Listeria monocytogenes. While no illnesses have been reported to-date, Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or […]
Today, the U.S. Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER is the second ER/LA opioid analgesic with FDA-approved labeling describing the […]
The U.S. Food and Drug Administration is alerting health care professionals and consumers of a voluntary recall of all non-expired drug products produced for sterile use by Unique Pharmaceuticals Ltd., of Temple, Texas.
The U.S. Food and Drug Administration today approved Zydelig (idelalisib) to treat patients with three types of blood cancers.
The U.S. Attorney for the Northern District of California today charged the FedEx Corporation with conspiring with two separate but related online pharmacy organizations to distribute controlled substances and prescription drugs to U.S. consumers without requiring their customers to have a valid prescription, as required by the Federal Food, Drug, and Cosmetic Act.
The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
As previously reported, on July 1, 2014, biological samples were found in the cold storage area of U.S. Food and Drug Administration laboratories on the National Institutes of Health campus. The FDA has since acquired additional information from the federal investigative agencies regarding inventories of the materials.
Charles Products, Inc. (CPI) announced today that it is voluntarily recalling shot and pint glasses identified below sold exclusively through M&M’S World retail stores in New York, Las Vegas, Orlando and London. Read The Complete Story!