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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Important Notice RabAvert Rabies Vaccine (Rabies Vaccine for Human Use) Kits

DATE NOTIFICATION INITIATED:

April 13, 2010

PRODUCT / LOT NUMBER / EXPIRATION DATE:

RabAvert Kit Batch #458011A  (Expires April, 2013)
Diluent vial batch #927011 (Expires April, 2014)

MANUFACTURER:

Novartis Vaccines and Diagnostics
Marburg, Germany

REASON:

Novartis Vaccines is implementing a voluntary market withdrawal of this single batch as the stopper and the metal crimp dislodge from the vial completely when removing the protective cap.  A low percentage of diluent vials exhibit this issue.  This is a precautionary action taken by Novartis as they have no evidence that the quality of the diluent is compromised as long as the stopper is not removed from the diluent vial. For patients who have received vaccine from this batch, no additional actions, such as revaccination, are required.

The vial of lyophilized rabies vaccine contained in these kits is not affected, but all RabAvert should be returned as complete kits.  Only the above-listed batch is subject to this voluntary market withdrawal; all other RabAvert batches are unaffected and safe for use.  Customers are requested to contact Novartis Vaccines Customer Service to arrange for product return.


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.