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

                                            

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