Vaccines, Blood & Biologics

Recall of MENVEO [Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine] Solution for intramuscular injection

DATE NOTIFICATION INITIATED:  July 11, 2017

PRODUCT / LOT NUMBER:

 Lot Number:  M16095     Expiration Date:  March 2018

5 DOSES (10 vials) per Package – NDC 46028-208-01

NDC 46028-208-01 includes 5 vials containing MenA Lyophilized Conjugate Component
(NDC 46028-218-11) and 5 vials containing MenCYW-135 Liquid Conjugate Component
(NDC 46028-219-11)

MANUFACTURER:

GSK Vaccines, Srl
Sovicille (SI), Italy

REASON:

GlaxoSmithKline (GSK) is recalling MENVEO® [Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine] Solution for intramuscular injection 5 DOSES (10 vials) per Package lot M16095. The recall is a precautionary measure since the associated batch was subject to a mechanical intervention executed during the aseptic filling operations, which is not supported by validation data.

Recalled product was shipped between January 4, 2017 and January 16, 2017.

GSK is asking consignees of (Menveo lot M16095 only) to stop distributing and immediately quarantine and return all units.


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.

Page Last Updated: 07/18/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English