Meningitis Vaccine: Precautionary Recall

A precautionary recall of Menveo, a meningitis vaccine, was announced by GlaxoSmithKline due to a mechanical intervention.

GlaxoSmithKline has initiated a recall of Menveo (meningococcal [Groups A, C, Y and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine) for intramuscular injection.1

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.

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  1. Recall of MENVEO [Meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine] solution for intramuscular injection [press release]. Washington DC: FDA; July 18, 2017.

This article originally appeared on MPR