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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall: Influenza A (H1N1) 2009 Monovalent Vaccine - Lot Numbers UT023DA, UT028CB, UT028DA, and UT030CA

DATE RECALL INITIATED:

December 16, 2009

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Lot NumberExpiration DateNDC#
UT023DA4/30/2011

49281-650-25 (which also may be recorded as

NDC # 49281-0650-25)

UT028CB4/9/2011

49281-650-25 (which also may be recorded as

NDC # 49281-0650-25)

UT028DA4/9/2011

49281-650-25 (which also may be recorded as

NDC # 49281-0650-25)

UT030CA3/30/2011

49281-650-70 (which also may be recorded as

NDC # 49281-0650-70)

Please stop using these lot numbers immediately and return all remaining inventory of these lot numbers.

MANUFACTURER:

Sanofi Pasteur

Swiftwater, Pennsylvania

REASON:

Sanofi Pasteur is initiating a voluntary recall of 4 lots of Influenza A (H1N1) 2009 Monovalent Vaccine, pediatric dose (0.25mL) prefilled syringes.  These lots were shipped in November and are intended for children 6 through 35 months of age.  No other distributed lots of Influenza A (H1N1) 2009 Monovalent Vaccine are affected. 

Sanofi Pasteur, Inc. has notified the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) that routine testing of its pediatric Influenza A (H1N1) 2009 Monovalent Vaccine in 0.25mL syringes has identified four distributed lots with lowerantigen content than the specification limit.

The FDA and the CDC have determined that there are no safety concerns with any of these lots.

The FDA and the CDC do not recommend repeating any doses that children received fromthese lots. This is because the drop in antigen content is unlikely to result in a clinically significant reduction in immune response. Children who have received one dose should receive the recommended second dose of Influenza A (H1N1) 2009 Monovalent Vaccine.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA.  Its accuracy and comprehensiveness cannot be guaranteed.