August 3, 2008FDA Reaches Settlement with California Hearing Device Maker FDA Reaches Settlement with California Hearing Device Maker
The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law. Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) FDA clarifies approved conditions for use of ESAs in patients with cancer and revises dosing directions for the products. Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient. Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software) Physicians warned not to use Blood Pumping System with Valleylab Force FX-C or SSE2L electrosurgery devices because use may result in stoppage of the pump and may cause serious injury or death. # posted by Network @ 2:00 PM
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