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Liquid Leukine Withdrawn from Market
The current liquid formulation of Leukine, a growth factor that helps fight infection and disease, has been withdrawn from the market because of an increase in reports of adverse reactions, including fainting. The problems seem to be caused by a recent change in the formulation to include edetate disodium (EDTA). Healthcare professionals should immediately stop using liquid Leukine and return unused vials to the manufacturer. For return instructions please call 1-888-842-2937 or visit the Bayer Web Site. The following NDCs are affected:
The complete MedWatch 2008 Safety Summary is available on the FDA Web site: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Leukine Additional information is also available at the Bayer Web site: http://www.pharma.bayer.com/scripts/pages/en/news_room/news_room/news_room48.php |
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