The U.S. Food and Drug Administration and San Diego-based Ocean Harvest Inc., an outlet for salmon, tuna, and other fresh fish intended for raw consumption, and Ocean Harvest president, Minkyu Park, recently signed a consent decree of permanent injunction. The company had been selling seafood that was handled in violation of federal food safety standards.
Category Archives: Food Safety News
FDA approves Nulojix for kidney transplant patients
The U.S. Food and Drug Administration today approved Nulojix (belatacept) to prevent acute rejection in adult patients who have had a kidney transplant. The drug is approved for use with other immunosuppressants (medications that suppress the immune system) — specifically basiliximab, mycophenolate mofetil, and corticosteroids.
FDA approves first ceramic-on-metal total hip replacement system
The U.S. Food and Drug Administration approved on June 13 the first ceramic-on-metal total artificial hip system for patients with osteoarthritis.
FDA approves new test to help determine if breast cancer patients are candidates for Herceptin treatment
The U.S. Food and Drug Administration today approved a new genetic test that will help health care professionals determine if women with breast cancer are HER2-positive and, therefore, candidates for Herceptin (trastuzumab), a commonly used breast cancer treatment.
FDA Announces Changes to Better Inform Consumers About Sunscreen
New Rules Give Consumers More Information to Help Reduce the Risk of Skin Cancer, Early Aging
ATALANTA CORP. Recalls 9 pounds of “Royal Blue Stilton” cheese Because Of Possible Health Risk
One 8-9 lb wheel of “Royal Blue Stilton” cheese contained in a master case with batch code B038 has been recalled by Atalanta Corporation, an Elizabeth, New Jersey based food distributor, because the product 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!
Federal government takes action against drug manufacturer and distributor
H&P Industries, Triad Group, and company officers agree to correct deficiencies
FDA approves Potiga to treat seizures in adults
On June 10, Potiga (ezogabine) tablets were approved by the U.S. Food and Drug Administration for use as an add-on medication to treat seizures associated with epilepsy in adults.
Potiga was approved for the treatment of partial seizures, the most common type of seizure seen in people with epilepsy.
FDA approves redesigned labels for some Merck drugs
The U.S. Food and Drug Administration today is announcing the approval of Merck’s redesigned drug container labels that include a new standardized format to improve readability and provide better information on product and strength differentiation.
FDA clears new system to perform simultaneous PET, MRI scans
The U.S. Food and Drug Administration today cleared the Siemens Biograph mMR system, the first device to simultaneously perform a positron emission tomography scan, commonly known as PET scan, and a magnetic resonance imaging (MRI) scan.