Sanofi Recalls Subpotent H1N1 Vaccine

Some Lots Issued Abbreviated Expiration Dates

Kate Traynor

BETHESDA, MD 03 February 2010—Six lots of Sanofi's monovalent H1N1 influenza vaccine have been recalled due to diminished potency, according to an announcement from the Centers for Disease Control and Prevention's (CDC's) Health Alert Network.

According to CDC, all six lots met potency standards when the vaccines were released but fell "slightly below" a prespecified threshold during subsequent quality testing.

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 health care providers between November 2009 and January 2010, according to CDC. The notice states that FDA and CDC have no concerns about the safety of these lots.

Patients who were vaccinated using these lots to not need to be revaccinated, CDC stated.

This recall involves different lots than those recalled in December.

In addition to the recalls, 14 previously distributed lots of 0.25-mL prefilled syringes containing Sanofi's H1N1 vaccine have been issued abbreviated expiration dates, according to a CDC announcement that was posted Tuesday.

The announcement, dated December 15, 2009, names lots UT014AA, UT014BA, UT014CA, UT014DA, UT014FA, UT014EA, UT029DA, UT029BA, UT029CA, UT029EA, UT030EA, UT030FA, UT033CA, and UT033DA, with labeled expiration dates of March 4–April 11, 2010.

All vaccine from these lots should be administered by February 15, according to CDC.