Health Advisory - Sanofi Pasteur Monovalent 2009 (H1N1) Influenza Vaccine Pre-Filled Syringes
Shortened Shelf Life of Certain Lots
To: H1N1 Vaccination Sites
From: Vermont Department of Health
Date: February 4, 2010
Sanofi Pasteur has notified the Centers for Disease Control & Prevention (CDC) and the Food & Drug Administration (FDA) that some lots of monovalent 2009 (H1N1) influenza vaccine in pre-filled syringes will have a shorter expiration date than indicated on the label.
The affected lots of Sanofi Pasteur monovalent 2009 H1N1 influenza vaccine in pre-filled syringes should be used by February 15, 2010, regardless of the expiration on the package.
This is to ensure that the vaccine is used while it remains within its potency specification. There are no safety concerns with these lots of 2009 H1N1 vaccine. People who received vaccine from the lots listed below with shortened shelf life do not need to take any action.
These affected lots were shipped to providers between November 2009 and January 2010. Although these lots remain potent, they are losing their potency more rapidly than expected, and therefore the shelf life is being shortened.Please prioritize use of the affected lots prior to February 15.
The change in expiration date described here is specific to the 50 lots of Sanofi Pasteur 2009 H1N1 influenza vaccine in pre-filled syringes listed below.The lots affected are different than those recently recalled due to reduced potency. These actions do not affect Sanofi Pasteur’s 2009 H1N1 vaccine in multi-dose vials.
The affected lots should be used by February 15, 2010, as indicated in the following pages, regardless of the expiration date imprinted on the package.
All pre-filled syringes that have not been used by February 15, 2010 should be disposed of and recorded as medical waste. If your practice has any questions or concerns about this recalled vaccine please contact the Immunization Program at (802) 863-7638 or immunizationprogram@vdh.state.vt.us.
| Product Code (NDC) 49281-650-25 | ||
|---|---|---|
| Description 0.25 mL syringes in 10-packs | ||
Lot Number |
Labeled Exp Date |
Re-Assigned Exp Date |
UT014AA |
March 4, 2011 |
February 15, 2010 |
UT014BA |
March 4, 2011 |
February 15, 2010 |
UT014CA |
March 4, 2011 |
February 15, 2010 |
UT014DA |
March 4, 2011 |
February 15, 2010 |
UT014EA |
March 25, 2011 |
February 15, 2010 |
UT014FA |
March 27, 2011 |
February 15, 2010 |
UT029BA |
April 6 , 2011 |
February 15, 2010 |
UT029CA |
April 6 , 2011 |
February 15, 2010 |
UT029DA |
April 7 , 2011 |
February 15, 2010 |
UT029EA |
April 8 , 2011 |
February 15, 2010 |
UT030EA |
April 10 , 2011 |
February 15, 2010 |
UT030FA |
April 11 , 2011 |
February 15, 2010 |
UT033CA |
April 12 , 2011 |
February 15, 2010 |
UT033DA |
April 12 , 2011 |
February 15, 2010 |
| Product Code (NDC) 49281-650-50 | ||
|---|---|---|
| Description 0.5 mL syringes in 10-packs | ||
Lot Number |
Labeled Exp Date |
Re-Assigned Exp Date |
UP033CA |
April 16, 2011 |
February 15, 2010 |
UP036CA |
April 19, 2011 |
February 15, 2010 |
UP034BB |
April 22, 2011 |
February 15, 2010 |
UP036EA |
May 3, 2011 |
February 15, 2010 |
UP037CA |
April 30, 2011 |
February 15, 2010 |
UP037DA |
May 2, 2011 |
February 15, 2010 |
UP048CA |
May 6, 2011 |
February 15, 2010 |
UP040CA |
May 4, 2011 |
February 15, 2010 |
UP048DA |
May 9, 2011 |
February 15, 2010 |
UP049FA |
May 16, 2011 |
February 15, 2010 |
UP049CA |
May 11, 2011 |
February 15, 2010 |
UP049DA |
May 13, 2011 |
February 15, 2010 |
UP035BA |
April 15, 2011 |
February 15, 2010 |
UP059DA |
May 16, 2011 |
February 15, 2010 |
UP060CA |
May 17, 2011 |
February 15, 2010 |
UP060DA |
May 19, 2011 |
February 15, 2010 |
UT047BA |
May 11, 2011 |
February 15, 2010 |
UT033AB |
April 9, 2011 |
February 15, 2010 |
UP041BA |
April 30, 2011 |
February 15, 2010 |
UT041AA |
April 29, 2011 |
February 15, 2010 |
| Product Code (NDC) 49281-650-50 | ||
|---|---|---|
| Description 0.5 mL syringes in 10-packs | ||
Lot Number |
Labeled Exp Date |
Re-Assigned Exp Date |
UT034AA |
April 19, 2011 |
February 15, 2010 |
UT045BA |
May 5, 2011 |
February 15, 2010 |
UP061DA |
May 21, 2011 |
February 15, 2010 |
UP061FA |
May 23, 2011 |
February 15, 2010 |
UP035AA |
April 12, 2011 |
February 15, 2010 |
UT048BA |
May 12, 2011 |
February 15, 2010 |
UT058BA |
May 16, 2011 |
February 15, 2010 |
UT059AA |
May 18, 2011 |
February 15, 2010 |
UT058AA |
May 14, 2011 |
February 15, 2010 |
UT061GA |
May 24, 2011 |
February 15, 2010 |
UP045EA |
June 9, 2011 |
February 15, 2010 |
| Product Code (NDC) 49281-650-90 | ||
|---|---|---|
| Description 0.5 mL syringes in 25-packs | ||
Lot Number |
Labeled Exp Date |
Re-Assigned Exp Date |
UT036DA |
April 26, 2011 |
February 15, 2010 |
UT040BA |
April 28, 2011 |
February 15, 2010 |
UT047AA |
May 9, 2011 |
February 15, 2010 |
UT046BA |
May 9, 2011 |
February 15, 2010 |
UT046AA |
May 4, 2011 |
February 15, 2010 |