GSK Recalls Flu Vaccine

April 20, 2015
Pharmaceutical Technology Editors

GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.

 

On April 16, 2015, GlaxoSmithKline (GSK) notified the Centers for Disease Control (CDC) and FDA that it would recall the remaining doses of its 2014–2015 Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes flu vaccines administered in early January 2015 and later. The recall, initiated because of the potential for reduced effectiveness due to a decrease in potency found during stability testing, was voluntary and does not pose a safety concern for individuals who received the vaccine.

The vaccine is meant to protect against four influenza viruses, included two influenza A viruses and two influenza B viruses. The recalled lots were found to have slightly reduced potency (less than 5% below the minimum specification) for the two influenza B viruses in the vaccine. The two influenza A viruses in the vaccine were within pre-specified limits. Thirteen lots of the vaccine are affected by the recall: 2B472, 379MY, 42N4L, 5AZ7H, 9A3ZM, ZS95Z, A2PK7, AR57J, DR4GF, YF5DT, F45C5, T3J4S, and XP4J2.

Source: CDC