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Delaware Health Alert Network #218

Feburary 4, 2010 9:26 am


Health Alert
SANOFI PASTEUR MONOVALENT 2009 (H1N1) INFLUENZA VACCINE IN PRE-FILLED SYRINGES - SHORTENED SHELF LIFE IN CERTAIN LOTS

The Delaware Division of Public Health (DPH) is forwarding this health alert from the Centers for Disease Control and Prevention. For more information from the Division of Public Health, contact the immunization program at 1-800-282-8672.

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 most 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, a related recall (See http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00306) was conducted recently, which involved lots from Sanofi Pasteur’s 2009 H1N1 vaccine in 0.25 mL and 0.5 mL pre-filled syringes. These actions do not 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.

DPH has determined that of the affected vaccine, the lot numbers listed below were delivered to providers in Delaware. DPH will send notifications to those providers that did not receive the vaccine directly from the CDC distributor McKesson. As indicated above, Sanofi will send notifications to those providers that received the vaccine directly from McKesson.

Table 1:Influenza A (H1N1) 2009 Monovalent Vaccine in Pre-Filled Syringes.
Expiration Date Change.Lot #’s received in Delaware


Lot # # of doses
UP035BA 3000
UP037CA 1500
UP040CA 200
UP048CA 1600
UP048DA 1160
UP059DA 1700
UP060CA 440
UT033CA 2673
UT041AA 2500
UT045BA 100
UT047BA 1000
UT048BA 100
UT058BA 100
UT036DA 900
UT047AA 1500
UT029BA 2170
UT029EA 3990

Table 2: 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:

Call 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

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