Non-safety Related Recall of Vaccine Product for Children
NASHVILLE – The Tennessee Department of Health has determined that health providers in the state received 11,210 doses of H1N1 flu vaccine now impacted by a voluntary, non-safety related recall. Sanofi Pasteur, Inc., is recalling four lots of H1N1 vaccine in 0.25 ml pre-filled syringes designed for use in children ages 6 to 35 months. These lots passed all tests for potency and purity when they were distributed, but routine follow-up tests after distribution found that levels of antigen, the active ingredient, were slightly lower than the level specified on the label. The recall is not related to any safety or effectiveness concerns.
Tennessee received only 1.4 percent of the Sanofi vaccine impacted by the recall, and these doses represent only 0.6 percent of all H1N1 flu vaccine distributed in Tennessee.
“Tennessee health providers who registered to offer H1N1 vaccine have been informed about the recall, and know they are to set aside any doses they received from the recalled lots,” said Health Commissioner Susan R. Cooper, MSN, RN. “There are other vaccine products available for use for young children, so we don’t anticipate a significant impact on supply of vaccine for that age group.”
The lot numbers of vaccine included in the recall are: UT023DA, UT028DA, UT028CB and UT030CA. Some 800,000 doses of H1N1 vaccine are included in these lots. The Department of Health is working with the Centers for Disease Control and Prevention to inform providers who received affected lots on instructions from Sanofi Pasteur for returning unused doses to the company.
No action is required by parents with children between the ages of 6 to 35 months who may have received H1N1 flu vaccine in the form of a pre-filled syringe from Sanofi Pasteur. The doses are considered safe and effective; revaccination is not recommended. Parents with questions may contact their child’s health provider, or call the Tennessee Flu Information line toll-free at 1-877-252-3432.