GlaxoSmithKline (GSK) is voluntarily recalling all remaining lots (10 lots) of 2014-2015 Flulaval Quadrivalent Thimerosal-Free Pre-Filled Syringes (PFS), each containing one 0.5-mL dose. As part of stability testing, GSK observed loss of potency below the minimum specification prior to product expiry for the B strains included in the vaccine. The lots are being recalled due to the potential for reduced efficacy offered by the vaccine and not as a result of any identified safety concerns.

This recall does not affect Flulaval Quadrivalent Multi Dose Vials (MDV), Flulaval [trivalent] MDV, or any other GSK vaccines.

In its recall notice, GSK said that no out-of-specification stability results were identified for product administered through end of 2014, the time period when the majority of influenza vaccinations occur in the US. Based on the stability results (less than 5% below minimum specification), GSK said it cannot rule out potential suboptimal protection for product administered from early January 2015 and beyond.

Source: GlaxoSmithKline