Recall of Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W-135 Combined, single-dose vials (including single-dose in five dose packaging), Menomune

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.

Last Updated: 10/24/2002