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.
For more information visit FDA.gov.