The U.S. Food and Drug Administration (FDA) today announced it is seeking a $2.2 million penalty against a California hearing aid manufacturer for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices …
The FDA notified consumers of a recall of, and advised them not to purchase or consume, the liquid dietary supplement products Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The Florida Department of Health recently provided reports to the FDA on 23 …
The FDA is conducting a safety review based on study data suggesting there may be an increased risk of death from cancer in diabetic patients using Regranex (becaplermin) Gel, a skin product used to heal leg and foot ulcers. While the review is ongoing, the FDA recommends health care professionals discuss the potential risks and …
The Food and Drug Administration (FDA) is advising consumers who have recently bought cantaloupes to check with the place of purchase to determine if the fruit came from Agropecuaria Montelibano, a growing and packing company in Honduras. If so, consumers should throw away the cantaloupes. Based on current information, fruit from this company appears to …
The U.S. Securities and Exchange Commission said on Monday that Canada‘s Biovail Corp. will pay $10 million to settle fines stemming from a probe into fraudulent accounting. The SEC said current and former senior Biovail executives were obsessed with meeting quarterly and annual targets, and they overstated earnings and hid losses to deceive investors. The …
Palo Alto Labs and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of two dietary supplements, Aspire36 and Aspire Lite. The products were recalled because they were found to contain Aildenafil in trace amounts and Dimethyl sildenafil thione, an analog of Sildenafil, a drug used to treat erectile dysfunction. The presence of …
Stephanie Mencimer, Mother Jones When it comes to notorious Bush political appointees, Daniel Troy’s name doesn’t usually make the top-10 list, overshadowed as he is by more high profile cronies such as FEMA’s Michael Brown. But for three years in the president’s first term, Troy served as the chief counsel to the Food and Drug …
FDA issued a Public Health Notification to inform healthcare professionals of an update to earlier FDA safety information on this product. The notification re-emphasizes the need for continued surveillance of patients treated with endovascular grafts, and provides updated information on the mortality risks associated with the use of the AneuRx Stent Graft System to prevent …
Roche and FDA informed healthcare professionals of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza.The label has been revised as follows: Influenza can be associated with a variety of neurologic and behavioral symptoms which can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. …
Boehringer Ingelheim and FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva. This product contains tiotropium bromide and is used to treat bronchospasm associated with chronic obstructive pulmonary disease. Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the …