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Drug Alerts & Recalls September 2008 Actions affect over 30 different generic drugs; cites serious manufacturing deficiencies The FDA issued two Warning Letters to Ranbaxy Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India. The Warning Letters identify the FDA's concerns about deviations from U.S. current Good Manufacturing Practice requirements. These actions are proactive measures to assure that all drugs that reach the American public are manufactured according to Good Manufacturing Practice requirements. Visit the FDA website for more information on this alert.
September 2008 Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) for January through March 2008 Visit the U.S. Food and Drug Administration's website for a list of products and potential signals of serious risks for these products that were identified during the period of January through March 2008 in the AERS database.
August 2008 Actavis Totowa, LLC Actavis Totowa, LLC, a generic drug manufacturer, has voluntarily recalled, at the retail level, all drug products that were manufactured at its Little Falls, NJ, facility. This recall was not prompted by product complaints or health hazards associated with the prescription medications but by operations which did not meet Actavis’ or the FDA’s standards for good manufacturing practices. Patients who may have these medications should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk.
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