Non-Safety Related Voluntary Recall Involves Low Antigen Levels
 

FOR IMMEDIATE RELEASE             Connecticut Department of Public Health

December 15, 2009                                   Contact: William Gerrish

                                                                  (860) 509-7270

 

 

The state Department of Public Health (DPH) has identified 62 providers statewide who have received 7,800 doses of H1N1 vaccine that were voluntarily recalled by the manufacturer.  The vaccine was recalled after the manufacturer, as part of their quality assurance program, found that the antigen content was lower than required potency levels during routine testing.  There are no safety concerns associated with this recall.

 

The recalled vaccine was manufactured by Sanofi Pasteur, Inc. and involved H1N1 pediatric (0.25 mL, for 6-35 month olds) vaccine in pre-filled syringes.  Between November 11 and November 30, 7,800 doses of the recalled vaccine were distributed to 62 providers throughout the state.  The Centers for Disease Control and Prevention (CDC) is not recommending that those who received the vaccine be re-vaccinated.  Children nine years old or younger who received the vaccine should receive a second dose of the vaccine as recommended with all H1N1 vaccines.

 

DPH has notified all providers who received the vaccine and the manufacturer will also contact the affected providers advising them how to return any unused vaccine.  For more information on the recalled vaccine, please go to http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm.

 

A public hotline for H1N1, staffed by representatives from DPH, is also available for people who may have questions about H1N1 flu or the H1N1 vaccine.  The public can call the H1N1 hotline at 1-800-830-9426, Monday through Friday, 9 a.m. to 5 p.m.

 

For more information on H1N1 flu, please go to www.ct.gov/ctfluwatch.

 

The Connecticut Department of Public Health is the state‚Äôs leader in public health policy and advocacy with a mission to protect and promote the health and safety of the people of our state.  To contact the department, please visit its website at www.ct.gov/dph or call (860) 509-7270.

 

###