The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
La FDA aprueba nuevo medicamento para el tratamiento de la infección de VIH
La Administración de Alimentos y Medicamentos aprobó hoy Tivicay (dolutegravir), un nuevo fármaco para tratar la infección de VIH-1.
FDA awards contract to develop promising new technology to test radiation countermeasures
The U.S. Food and Drug Administration has awarded a $5.6 million contract to Harvard University’s Wyss Institute for Biologically Inspired Engineering to apply its breakthrough organs-on-chips technology to assess medical countermeasures for treating acute radiation syndrome (ARS), also known as radiation sickness.
FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding
The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all products produced and distributed for sterile use by Specialty Compounding, LLC, Cedar Park, TX. There have been recent reports of bacterial bloodstream infections potentially related to the company’s calcium gluconate infusions.
Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events
Specialty Compounding, LLC, a subsidiary of Peoples Pharmacy Inc., is voluntarily recalling all lots of sterile medications within expiry. The recall was initiated after reports of bacterial infection affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area, whose treatment included IV infusions of calcium gluconate from Specialty Compounding.
FDA approves first rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies
The U.S. Food and Drug Administration today approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for use as an aid in the diagnosis of HIV-1 and HIV-2 infection, the Alere Determine HIV-1/2 Ag/Ab Combo test is also the first FDA-approved test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test.
Gold Star Smoked Fish Corp. Issues an Alert on Listeria in Baltic Treasures, Norwegian Style Matjes, Marinella "Delicatessnaya", Jewish Style Matjes, Traditional Russian Matjes,and Rybacka Wies Matjes Brands of Herring Fillets in Oil
Gold Star Smoked Fish Corp., Iocated at 570 Smith Street, Brooklyn, NY 11231, is recalling Baltic Treasures, Norwegian Style Matjes, Marinella “Delicatessnaya”, Jewish StyleMatjes, Traditional Russian Matjes, and Rybacka Wies Matjes Brands of Herring Fillets in Oil due to contamination or possible contamination with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems.
Health and Beyond LLC Issues Voluntary Nationwide Recall of Tranquility Product Due to Product Having Traces of Pharmaceutical Ingredients
Boca Raton, FL, Health and Beyond LLC is voluntarily recalling quantity lots of product Tranquility. The products have been found to contain a trace of Doxepin which is a pharmaceutical for sleep and Chlorpormazine for psychotic disorders.
Zip International Group, LLC Recalls Baltic Sprats in Spicy Brine Because of Possible Health Risk
ZIP INTERNATIONAL GROUP LLC, 160 Raritan Center Parkway #6, Edison, NJ 08837, is recalling Baltic Sprats in Spicy Brine Net Wt. 15.8 Oz (450g) in plastic packaging because it is 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.
Evershing International Trading Inc. Announces Recall of Ginger Candy
August 2, 2013 – Evershing International Trading, Inc. of San Jose, CA is recalling all Ginger Candy it received from Lucky Shing Company due to elevated levels of lead. Ginger Candy is imported from Vietnam.