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DATE RECALL INITIATED: July 30, 2001 LOT NUMBER / EXPIRATION DATE: X29601 01/11/2003 MANUFACTURER: Aventis Behring L.L.C. King of Prussia, PA REASON: The lot, which met all test specifications at the time of release, currently tests to be around 900 IU, which is approximately 76% of the labeled potency of 1030 IU. The current potency is approximately 4% below the minimum potency specification for the product. No adverse event reports or product technical complaints have been associated with this lot. For Medical information relating to this recall call Aventis Behring at 1-800-504-5434. Information relating to this recall is available at the recalling firm’s website at http://www.aventisbehring.com/na. The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Updated April 5, 2002

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