GlaxoSmithKline (GSK) Reports Flu Vaccine Recall

April 16, 2015 – GlaxoSmithKline (GSK) has notified CDC and FDA that it is recalling remaining doses of its 2014-2015 FLULAVAL® QUADRIVALENT Thimerosal-free Pre-Filled Syringes (PFS) flu vaccine. This recall does not affect FLULAVAL QUADRIVALENT Multi Dose Vials (MDV), FLULAVAL [trivalent] MDV or any other GSK vaccines. GSK voluntarily initiated this recall because of the potential that FLULAVAL pre-filled syringes may have reduced effectiveness due to a decrease in potency detected through routine testing. The vaccine’s potency fell below a pre-specified limit prior to the expiration of the vaccine. According to GSK, the potency issue only affects FLULAVAL pre-filled syringe vaccine doses administered in early January 2015 or later. Doses of this vaccine administered through the end of 2014 did not fall below specified potency limits. The reduced potency of the GSK FLULAVAL pre-filled syringes vaccine does not pose a safety concern for people who received it.

http://www.cdc.gov/flu/news/gsk-flu-vaccine-recall.htm