The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) announced that Sanofi Pasteur is voluntarily recalling three lots of its Fluzone Quadrivalent (quadrivalent inactivated “split virus” influenza vaccine [Types A and B]) due to potency issues.
The voluntary recall was initiated by Sanofi Pasteur after it was discovered that the vaccine’s potency fell below a pre-specified limit prior to the expiration of the vaccine that could lead to less than optimal effectiveness. The CDC is not recommending revaccination for those who received the recalled vaccine due to declining flu activity at this time. The reduced potency of the affected lots does not pose a safety concerns for those patient show received this vaccine. This recall does not affect any other lots of Fluzone Quadrivalent vaccine or any other presentations of Sanofi Pasteur’s Fluzone vaccines.
The affected products are sold as 10-dose vials with Lot # UI196AA, UI190AC, and UI190AD, all with an expiration date of June 30, 2015. The full details can be found on the CDC website. Sanofi Pasteur has sent customers who purchased vaccine from any of the recalled lots instructions to not use the remaining vaccine and it has provided directions for returning unused doses.
For more information call (800) 232-4636 or visit CDC.gov.