Voluntary Recall of Meningitis Vaccine

GlaxoSmithKline has initiated a recall of Menveo (meningococcal [Groups A, C, Y and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine) for intramuscular injection. Specifically, the recall is for NDC# 46028-208-01; Lot#  M16095 with expiration date of March 2018. The recalled product is supplied with the accompanying MenCYW-135 liquid conjugate vaccine component (NDC# 46028-218-11).

This recall is considered precautionary as the batch associated with the recall was subject to a “mechanical intervention executed during the aseptic filling operations, which is not supported by validation data.” 

Menveo is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. It is approved for use in persons 2 months through 55 years of age.

Reference

Recall of MENVEO [meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine] solution for intramuscular injection [press release]. Washington, DC: US Food and Drug Administration. Published July 11, 2017. Accessed August 8, 2017.

This article originally appeared on MPR