Potency worries prompt GSK flu vaccine recall

An article from FierceVaccines
April 20, 2015
To cap off one of the least effective seasons for flu vaccines in recent memory, vaccine producer GlaxoSmithKline ($GSK) announced the recall of all remaining doses of a quadrivalent, affecting roughly 1.7 million jabs.
Citing potency concerns, the U.K.-based drugmaker wants back all of its FluLaval Quadrivalent Thimerosal-Free vaccines in prefilled syringes, stating that over time, the vaccines can become less effective. In routine testing, GSK found that the vaccine's potency could be found to hit below required level. However, the drugmaker added that 99% of the drugs were distributed in 2014 with appropriate potency, AP reports. Glaxo is unsure how many doses remain unused.
The doses were produced at a troubled plant in Quebec City, Canada, FiercePharmaManufacturing reports, which has attracted FDA attention and a warning letter questioning the quality of the FluLaval vaccine. The regulator cited problems with purified water at the plant, and GSK eventually suspended production to investigate "irregular results" in quality control monitoring.
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