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Delaware Health Alert Network #348

April 24, 2015 4:26 pm


Health Advisory
VOLUNTARY FLU VACCINE RECALL

Background

The Centers for Disease Control and Prevention (CDC) has notified Delaware’s Division of Public Health Immunization Program of a voluntary flu vaccine recall by Sanofi Pasteur of the 2014-2015 Fluzone Quadrivalent influenza vaccine in multi-dose vial formulation (NDC # 49281-0621-15). Three lots distributed in the United States are affected because the antigen content has declined below stability specification limit.

According to Sanofi Pasteur, there are no safety concerns related to the recall and re-vaccination is not required.

Recommendations

Out of an excess of caution, providers that have any doses from the listed lots are advised not to administer them. The doses should be stored separate from vaccine in use. Sanofi Pasteur will mail return instructions directly to those providers that received the affected vaccine lots.

The three lots involved are:

Lot Number Expiration NDC Vial NDC Presentation
UI196AA 30JUN15 49281-621-15 49281-621-78 10-dose
UI190AC 30JUN15 49281-621-15 49281-621-78 10-dose
UI190AD 30JUN15 49281-621-15 49281-621-78 10-dose


Additional Information

Contact Sanofi Pasteur at 800-822-2463, Monday-Friday, 8:30 a.m.-6:0 p.m. or the Delaware Immunization Program at 800-282-8672 or 302-744-1060 if you have questions.

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