MedImmune Changed Expiration Date (1/11/10)

On January 11, 2010 MedImmune announced some lots of its nasal spray H1N1 vaccine has a shorter expiration period than that indicated on the label.

The following lots are affected by the shorter dating period:

Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Expiration Date Update
Lots shipped to providers in North Carolina are bold.

Product Code (NDC)	Lot Number	Labeled Expiration Date	Re-Assigned  Expiration Date
66019-200-01 66019-200-05 66019-200-10	500778P	1/29/2010	1/15/2010
	500779P	2/4/2010	1/15/2010
	500780P	2/6/2010	1/15/2010
	500781P	2/10/2010	1/15/2010
	500782P	2/11/2010	1/15/2010
	500783P	2/12/2010	1/15/2010
	500784P	2/14/2010	1/15/2010
	500785P	2/16/2010	1/15/2010
	500796P	2/17/2010	1/15/2010
	500797P	2/19/2010	1/15/2010
	500798P	2/21/2010	1/15/2010
	500799P	2/22/2010	1/15/2010

 

 

 

• Memo from the N.C. Immunization Branch: For Certain Providers: Important Information Regarding MedImmune H1N1 Nasal Spray Vaccine Expiration Dating (January 11, 2010) 

Sanofi Pastuer Recall (1/29/10)

On January 29, 2010 Sanofi Pastuer issued a voluntary, non-safety recall of five lots of its pediatric pre-filled syringes and one lot of adult pre-filled syringes. These lots were found to have dropped below a pre-specified limit required for potency.

Vaccine doses with the following lot numbers are included in the recall:

0.25 mL pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25):

• UT023AA
• UT023BA
• UT023CA
• UTO23FA
• UTO23EA

0.5 mL pre-filled syringes, 25-packs (NDC # 49281-650-90, sometimes coded as 49281-0650-90):

• UT037AA

Sanofi Pasteur will send providers directions for returning any unused vaccine from these lots. If you transferred vaccine to another provider in your community, please share this information with them.  Also be sure to pass along Sanofi Pasteur’s directions for returning unused vaccine.These lots were shipped to providers between November 2009 and January 2010.

The CDC and the FDA are in agreement that revaccination is not needed for those who received vaccine from these lots. However, as is recommended for all 2009 H1N1 vaccines, all children less than 10 years old should receive the two doses of H1N1 vaccine approximately a month apart for the optimal immune response.

North Carolina received 26,900 doses of the vaccine impacted by this recall.  Those doses were distributed to 160 providers across the state from November through December.

• Memo from the N.C. Immunization Branch For Affected Providers: Sanofi Recall (2/1/10)

Sanofi Pastuer Changed Expiration Date (2/3/10)

On February 3, 2010 Sanofi Pastuer announced some lots of its monovalent 2009 (H1N1) influenza vaccine in prefilled syringes will have a shorter expiration period than indicated on the label. The lots 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.

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

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

• Memo from the N.C. Immunization Branch: For All H1N1 Providers: Sanofi Shortened Shelf Life (2/3/10)

Last Updated: March 11, 2010

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