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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:
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):
0.5 mL pre-filled syringes, 25-packs (NDC # 49281-650-90, sometimes coded as 49281-0650-90):
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.
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) MedImmune Changed Expiration Date (3/29/10)On March 29, 2010 MedImmune announced some lots of it Influenza A (H1N1) 2009 Monovalent Vaccine, Live Intranasal have a shorter expiration period than that indicated on the label. The lots should be used by March 29, 2010, as indicated in the table below regardless of the expiration imprinted on the package. There are no safety concerns with these lots of 2009 H1N1 vaccine. Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Expiration Date Update
MedImmune Changed Expiration Date - Additional Lots (4/5/2010)On April 5, 2010 MedImmune announced some lots of it Influenza A (H1N1) 2009 Monovalent Vaccine, Live Intranasal have a shorter expiration period than that indicated on the label. The lots should be used by the dates indicated in the table below regardless of the expiration imprinted on the package. There are no safety concerns with these lots of 2009 H1N1 vaccine. At this time there is no remaining LAIV available for ordering. Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Expiration Date Update
Sanofi Pasteur Shortened Expiration Date (8/12/10)Sanofi Pasteur notified CDC and FDA that monovalent 2009 (H1N1) influenza vaccine in multidose vials will have a shorter expiration period than indicated on the label. Sanofi Pasteur monovalent 2009 H1N1 influenza vaccine in multidose vials should be used by September 15, 2010, 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 multidose vials with shortened shelf life do not need to take any action.
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