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:
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