The U.S. Food and Drug Administration has announced that the United States District Court for the Eastern District of California, Sacramento Division, entered a consent decree of permanent injunction against John C. Virtue, doing business as Virtue Calves, and Shannon L. Virtue for selling veal calves for use as food that contain illegal drug residues in violation of federal law.
Category Archives: Drug Recalls & Safety Notices
FDA approves Arcapta Neohaler to treat chronic obstructive pulmonary disease
The U.S. Food and Drug Administration today approved Arcapta Neohaler (indacaterol inhalation powder) for the long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.
FDA: New York dietary supplement manufacturer enters into consent decree
The U.S. Food and Drug Administration has announced that Howard Sousa, doing business as the Artery Health Institute LLC, and DeSousa LLC, in New York, N.Y., has signed a consent decree of permanent injunction. The consent decree prohibits Sousa from distributing products with claims in the labeling to cure, treat, mitigate or prevent diseases.
FDA: Do not eat Evergreen Produce brand alfalfa sprouts or spicy sprouts
The FDA is advising consumers not to eat Evergreen Produce brand alfalfa sprouts and spicy sprouts. The sprouts are possibly linked to 20 reported cases, including one hospitalization, of Salmonella Enteritidis in Idaho, Montana, New Jersey, North Dakota and Washington State. The strain of S. Enteritidis is rarely seen at this frequency.
FDA modifies dosing recommendations for Erythropoiesis-Stimulating Agents
The U.S. Food and Drug Administration today recommended more conservative dosing guidelines for Erythropoiesis-Stimulating Agents (ESAs) when used to treat anemia in patients with chronic kidney disease (CKD) because of the increased risks of cardiovascular events such as stroke, thrombosis, and death.
FDA: Maryland food manufacturer enters into consent decree
The U.S. Food and Drug Administration announced that Sungwon Inc of Columbia, a Columbia, Md., corporation, and the company’s president, Sang Ja Lee, have signed a consent decree of permanent injunction.
FDA provides updated safety data on silicone gel-filled breast implants
The U.S. Food and Drug Administration released a report today updating the clinical and scientific information for silicone gel-filled breast implants, including preliminary safety data from studies conducted by the manufacturers as a condition of their November 2006 approval.
HHS RELEASE: FDA unveils final cigarette warning labels
The U.S. Food and Drug Administration (FDA) today unveiled the nine graphic health warnings required to appear on every pack of cigarettes sold in the United States and in every cigarette advertisement. This bold measure will help prevent children from smoking, encourage adults who do to quit, and ensure every American understands the dangers of smoking.
FDA examines ways to improve consumer understanding of prescription drug ads
Findings from three studies conducted by the U.S. Food and Drug Administration confirm that the way information is conveyed and displayed in printed drug advertising affects consumer understanding of prescription medications.
FDA issues draft guidance for early version of an artificial pancreas system
The U.S. Food and Drug Administration today issued draft guidance that will help advance the development and approval of an artificial pancreas system to treat type 1 diabetes in the United States.