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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Notification of Voluntary Market Recall of MENVEO lot # M12115

 

DATE NOTIFICATION INITIATED: December 2, 2013
 
PRODUCT / LOT NUMBER
 
MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine, NDC: 46028-208-01
 
Lot # M12115 (Men A vial Lot # A12115 and Men CWY vial lot # X12115)
 
MANUFACTURER: 
 
Novartis Vaccines and Diagnostics, Inc.
Rosia, Italy
 
REASON:
 
Novartis Vaccines is implementing a voluntary market recall of one lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine. This precautionary and voluntary action is being taken following observation of higher-than-specified levels of residual moisture within the lyophilized MenA component vial in the lot noted above. This residual moisture content is not expected to impact product quality, but constitutes a deviation to registered specifications. All other aspects of this lot have met the required quality standards.
 
It is important to note that no action is required for patients previously vaccinated with a dose from this lot.
 
Customers are asked to check their inventory and follow the steps outlined in the notification.

 
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.