GlaxoSmithKline ($GSK) is recalling 1.7 million doses of its quadrivalent flu vaccine that was manufactured at a plant that ran into a series of manufacturing issues last year including an FDA warning letter. The company says there are questions about whether the vaccine is retaining its potency.
"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 drugmaker said in a letter to distributors and healthcare providers issued last week. "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 concern."
In an emailed statement, GSK spokeswoman Anna Padula said the voluntary recall to U.S. customers was "for all remaining doses of FluLaval Quadrivalent Thimerosal-Free (Influenza) Vaccine, in the Pre-Filled Syringe, which were provided to the U.S. market for the 2014/15 flu season." According to the Associated Press, it was unknown how many of the 1.7 million units were still on the market since 99% of it was distributed in 2014, before the potency began to wane.
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