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DATE RECALL INITIATED: October 18, 2002 LOT NUMBERS / EXPIRATION DATE: UB040AA 7/25/2003 UB040AB 8/14/2003 UB070AA 9/26/2003 UB096AA 9/28/2003 MANUFACTURER: Aventis Pasteur Swiftwater, Pennsylvania DISTRIBUTOR: REASON: Product failed to meet potency specification during stability testing at 12 months. This failure may affect efficacy in preventing serogroup A meningococcal disease, however, does NOT affect the efficacy against serogroup C, Y, W-135. The firm recommends revaccination for those persons who were vaccinated since January 2, 2001 and have laboratory or industrial exposure to the serogroup A organism, or who may be traveling to high-risk countries for contracting serogroup A meningococcal disease. 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 October 24, 2002

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