12.15.09 Update – Voluntary H1N1 Vaccine Recall  

The Montgomery County Health Department is aware of the voluntary recall of certain lots of Sanofi Pasteur H1N1 Pediatric Vaccine in Pre-Filled Syringes. Earlier this month Sanofi Pasteur notified CDC and FDA that the potency in one lot (batch) of pediatric syringes that had been distributed was later found to have dropped below a pre-specified limit.  

A thorough inventory conducted on December 15 revealed that Montgomery County Health Department has not received or administered any of the vaccine lots in question. The Department encourages Montgomery County healthcare providers to review the lot numbers to their H1N1 vaccine and, as a precautionary measure, to return any vaccine whose lot number makes the Sanofi list.  

Despite the recall, health officials find no safety concerns with the lots of H1N1 vaccine recalled by Sanofi Pasteur. Both the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) have determined that the recalled vaccine’s potency is only slightly below the ideal range, so children given the recalled vaccines do not need to be revaccinated. 

Parents whose children received recalled vaccines do not need to take any action. However, they should ensure that all of their children under age 10 receive two H1N1 vaccinations, regardless of what formulation or lot number they received.  

For more information about the vaccine recall, please visit the CDC web site, http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm. 

Emily Smith Llinás, MS

Public Health Preparedness Director
Montgomery County Health Department
701 E. Davis, Suite A
Conroe, TX 77301
936.525.2800 - main
936.539.9272 - fax

www.utmb.edu/mchd