Safety Alerts & Recalls

What does this mean?

This recall is intended to notify any healthcare providers who may still have some of the recalled vaccine in their refrigerators. At this time, there are no safety concerns with these recalled lots of H1N1 vaccine. The vaccine potency in these recalled lots 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 you or your child has already received an H1N1 vaccine, the FDA and CDC have indicated that there is no need to re-administer the dose.

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 Additional Lots of Sanofi Pasteur H1N1 Vaccine

Sanofi Pasteur is voluntarily recalling five lots of pediatric H1N1 influenza vaccine and one lot of H1N1 influenza vaccine for older children and adults given to prevent H1N1 influenza (often called "swine flu") because of a slight decrease in their potency that was detected during regular follow up testing. These vaccines were within potency specifications at the time of distribution.

The recalled lots are UT023AA, UT023BA, UT023CA, UT023EA, UT023FA, packaged as 0.25 mL prefilled syringes in packs of 10 each and UT037AA, packaged as 0.5 mL prefilled syringes in 25-packs. These lots were shipped to healthcare providers between November 2009 and January 2010, according to CDC. The FDA and CDC have no concerns about the safety of these lots. This recall involves different lots than those recalled in December 2009.

For more information, please visit: more information here

In addition to the recalls, 14 previously distributed lots of 0.25-mL prefilled syringes containing Sanofi's H1N1 vaccine have been issued a shorter expiration period than indicated on the label. For more information about these lots with shortened expiration dates, please visit: more information here

Source: Manufacturer
Publication Date: 2010-02-03
Last Updated: 2010-02-03
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