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This is an official
CDC HEALTH UPDATE

 

Distributed via Health Alert Network
Tuesday, February 02, 2010, 18:45  EST (6:45  PM EST)
CDCHAN-00309-2010-02-02-UPD-N

Sanofi Pasteur Monovalent 2009 (H1N1) Influenza
Vaccine in Pre-Filled Syringes - Shortened Shelf Life of Certain Lots

Summary

Sanofi Pasteur has notified CDC and FDA that some lots of monovalent 2009 (H1N1) influenza vaccine in prefilled syringes will have a shorter expiration period than indicated on the label. The lots of Sanofi Pasteur monovalent 2009 H1N1 influenza vaccine in prefilled syringes should be used by February 15, 2010, as indicated in the table below regardless of the expiration imprinted 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.

Background

As part of its quality assurance program, Sanofi Pasteur performs routine, ongoing stability testing of the vaccine after it has been shipped to providers. Stability testing means measuring the strength of a vaccine over time.

The 50 lots subject to this change in expiration date include approximately 12 million doses. These 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. While many of the doses from these lots are believed to have already been administered, there are almost certainly some doses that have not yet been used.

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. However, two related recalls (See http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00306 and http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00303) were conducted recently, which involved lots from Sanofi Pasteur's 2009 H1N1 vaccine in 0.25 mL and 0.5 mL pre-filled syringes. The field adjustment and these related recalls affect all of the Sanofi Pasteur H1N1 vaccine in prefilled syringes that was distributed this season. These actions do not, however, affect Sanofi Pasteur's 2009 H1N1 vaccine in multi-dose vials.

Sanofi Pasteur will send a notification to providers who received doses from any of the 50 lots of vaccine described below.

Lot Information

These lots should be used by February 15, 2010, as indicated in the table below regardless of the expiration date imprinted on the package.

All pre-filled syringes that have not been used by February 15, 2010 should be discarded in an appropriate manner, or you may return the product for destruction to Sanofi Pasteur Inc., c/o Capital Returns at 6101 N. 64th Street, Milwaukee, WI 53218.

Influenza A (H1N1) 2009 Monovalent Vaccine
in Pre-Filled Syringes Expiration Date Change

Product Code (NDC)

Description

Lot Number

Labeled Expiration
Date

Re-Assigned
Expiration
Date

49281-650-25
0.25mL
syringes in
10-packs
 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
UT014FA March 27, 2011 February 15, 2010
UT014EA March 25, 2011 February 15, 2010
UT029DA April 7, 2011 February 15, 2010
UT029BA April 6, 2011 February 15, 2010
UT029CA April 6, 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
49281-650-50

0.5mL
syringes in
10-packs

 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
UP033AB April 9, 2011 February 15, 2010
UP041BA April 30, 2011 February 15, 2010
UT041AA April 29, 2011 February 15, 2010
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
49281-650-90
0.5mL
syringes in
25-packs
 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

For More Information:

  • CDC's toll-free information line, 800-CDC-INFO (800-232-4636)
    TTY: (888) 232-6348, is available 24 hours a day, every day.

  • For other inquiries, please contact Sanofi Pasteur Customer Services:
    1-800-VACCINE (1-800-822-2463) or visit www.vaccineshoppe.com.

The Centers for Disease Control and Prevention (CDC) protects people's health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national and international organizations.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Categories of Health Alert messages:
  • Health Alert - provides vital, time-sensitive information for a specific incident or situation; warrants immediate action or attention by health officials, laboratorians, clinicians, and members of the public; and conveys the highest level of importance. Example: HAN00001
  • Health Advisory - provides important information for a specific incident or situation; contains recommendations or actionable items to be performed by public health officials, laboratorians, and/or clinicians; may not require immediate action. Example: HAN00316
  • Health Update - provides updated information regarding an incident or situation; unlikely to require immediate action. Example: HAN00309
  • HAN InfoService - provides general public health information; unlikely to require immediate action. Example: HAN00319

##This message was distributed to state and local health officers, public information officers, epidemiologists, and HAN coordinators.##


Additional Resources
Contact Us:
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