Princess House, Inc. Voluntarily Recalls Marissa Tangerine Appetizer Plates Due to Cadmium and Lead Levels

June 2, 2014Food & Drug Recallsadmin

A nationwide direct sales distributor of tableware and house goods, announced today that as a result of internal compliance and independent product testing, it has very recently become aware that a small quantity of its Marissa Tangerine Appetizer Plates, when put into certain food service use, may allow cadmium and lead in the decorative plate decal to escape at levels exceeding U.S. Food and Drug Administration (“FDA”) and/or California Proposition 65 guidance levels.

While not all Plates distributed by the Company have this condition, Princess House is voluntarily recalling all these Plates distributed through its consultant and hostess network.

Alexion Initiates Voluntary Nationwide Recall of Certain Lots of Soliris® (eculizumab) Concentrated Solution for Intravenous Infusion Due to the Presence of Visible Particulate Matter in a Single Lot

June 2, 2014Food & Drug Recallsadmin

Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced that it is initiating a voluntary recall of certain lots of Soliris® (eculizumab) 300 mg/30 mL concentrated solution for intravenous infusion that were manufactured using a process component during vial filling identified in the November 2013 recall to the hospital/user level. As previously stated, Alexion believes that it has identified the process component that resulted in the presence of the visible particles and implemented a change to the process.

FDA launches openFDA to provide easy access to valuable FDA public data

June 2, 2014Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

Today, the U.S. Food and Drug Administration launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency.

FDA approves first generic versions of celecoxib

May 31, 2014Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.

FDA allows marketing of first non-invasive test to help in identifying cause of certain kidney disease

May 30, 2014Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

Today, the U.S. Food and Drug Administration allowed marketing of the first test that can help determine if a specific type of kidney disease, called membranous glomerulonephritis (MGN), is due to the body’s rejection of its own kidney tissue (autoimmune) or if it is due to another cause (such an infection).

FDA to require warnings on sunlamp products

May 30, 2014Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

Today, the U.S. Food and Drug Administration issued a final order reclassifying sunlamp products and ultraviolet (UV) lamps intended for use in sunlamp products from low-risk (class I) to moderate-risk (class II) devices. The order also requires that sunlamp products carry a visible black-box warning on the device that explicitly states that the sunlamp product should not be used on persons under the age of 18 years. In addition, certain marketing materials for sunlamp products and UV lamps must include additional and specific warning statements and contraindications.

FDA approves first implantable wireless device with remote monitoring to measure pulmonary artery pressure in certain heart failure patients

May 29, 2014Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

The U.S. Food and Drug Administration today approved the CardioMEMSHF System that measures the pulmonary artery (PA) pressures and heart rates of patients with New York Heart Association (NYHA) Class III heart failure who have been hospitalized for heart failure in the previous year. The device allows health care professionals to monitor the condition of their patients remotely.

La FDA aprueba el primer dispositivo inalámbrico implantable para medir la presión arterial pulmonar a distancia en ciertos pacientes con insuficiencia cardiaca

May 29, 2014Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) de los Estados Unidos aprobó hoy el Sistema CardioMEMSHF, que mide la presión arterial pulmonar (AP) y la frecuencia cardiaca de los pacientes con insuficiencia de la clase III, según la clasificación de la Asociación del Corazón de Nueva York (NYHA, por sus siglas en inglés), y que han sido hospitalizados por insuficiencia cardiaca en el último año. El dispositivo permite a los profesionales de la salud vigilar el estado de sus pacientes a distancia.

Navitas Naturals Issues Voluntary Recall for Organic Sprouted Chia Seed Powder Products

May 28, 2014Food & Drug Recallsadmin

Navitas Naturals, the Superfood Company is voluntarily recalling products which contain Organic Sprouted Chia Powder due to possible health risks related to Salmonella contamination. â€œWe have chosen to voluntarily recall products containing Organic Sprouted Chia Powder with the goal of utmost safety for our consumersâ€� stated Zach Adelman, Navitas Naturals CEO.

Eugene Oregon, Inc. Issues Voluntary Nationwide Expansion Of The Recall Of All Lots Of African Black Ant, Black Ant, And Mojo Risen Dietary Supplements Which May Contain Undeclared Active Pharmaceutical Ingredients