Safety Alerts & Recalls
What does this mean?
There are no safety concerns with these recalled lots of H1N1 vaccine. The vaccine potency is only slightly below the "specified" range. The vaccine in these lots is still expected to be effective in stimulating a protective response against H1N1 influenza despite this slight reduction in the concentration of the active ingredient (also called antigen).
If your child has already received a vaccine from one of these recalled lots, there is no need to re-administer the dose. However, as is recommended for all 2009 H1N1 vaccines, all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the optimal immune response. Therefore, children less than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine.
If you have any questions about this recall or about the H1N1 influenza vaccine, please follow up with your doctor or other primary healthcare provider.
Voluntary Recall of Certain Lots of Sanofi Pasteur H1N1 Pediatric (0.25 mL, for 6-35 month olds) Vaccine
Sanofi Pasteur is voluntarily recalling four lots of H1N1 Pediatric (0.25 mL) Vaccine in Pre-Filled Syringes, intended for young children, ages 6 months to almost three years (35 months). The H1N1 Vaccine is given as two doses, separated by 1 month, to prevent H1N1 influenza (often called "swine flu"). Sanofi Pasteur performs routine, ongoing stability testing of its influenza A (H1N1) vaccine after the vaccine has been shipped to healthcare providers. Stability testing is a measure of the strength or potency of a vaccine over time. During routine stability testing, Sanofi Pasteur found that doses from four vaccine lots no longer met the manufacturer's specifications for potency.
Vaccine doses with the following lot numbers are included in the recall: 0.25 ml pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25): UT023DA UT028DA UT028CB
0.25 ml pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70): UT030CA
The four lots of vaccine met all required specifications at the time of release and shipment to distribution centers. The H1N1 vaccine provided in multi-dose vials and the single-dose, 0.5 mL pre-filled syringes for persons 36 months and older continues to meet all specifications.
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