Non-Safety Related Voluntary Recall of Certain Lots of H1N1 Pediatric (0.25 mL for 6-35 months old) Vaccine in Pre-Filled Syringes
The Kentucky Department for Public Health was notified today that Sanofi Pasteur, the manufacturer of H1N1 (swine flu) vaccine found four distributed lots of single-dose, pre-filled syringe pediatric (0.25 mL.) vaccine with antigen content lower than required potency levels. The manufacturer is conducting a non-safety related voluntary recall of these affected lots of vaccine. Kentucky received a total of 21,800 .25mL doses in prefilled syringes shipped to providers statewide. We have provided the lot numbers to our local health departments so that they can track down the implicated lots themselves. The State Department for Public Health will also notify all providers directly to make sure that the lots are recovered.
It is important to note that this is only a potency issue and not a safety issue. The antigen content of the implicated vaccine tested above the specification limit when produced but fell slightly below that limit on later testing. CDC determined that the reduction is small enough that there is no need to revaccinate children who were vaccinated with recalled lots, but kids under 10 still need their two doses of H1N1 vaccine.
For More Information:
•For questions and answers related to the withdrawn vaccine see http://www.cdc.gov/h1n1flu/vaccination/syringes_qa.htm
•Call CDC’s toll-free information line, 800-CDC-INFO (800-232-4636) TTY: (888) 232-6348, which is available 24 hours a day, every day.