US Pharm. 2010;35(1):14.
Atlanta, GA — Citing low potency, Sanofi Pasteur has recalled about 800,000 pediatric doses of its vaccine against pandemic H1N1 influenza, according to the CDC. The agency, which is not requiring revaccinations, said, “There are no safety concerns with these lots of H1N1 vaccine. All lots successfully passed prerelease testing for purity, potency, and safety.” The recalled doses come from four lots of 0.25-mL prefilled syringes for pediatric use in both 10-packs (lot numbers UT023DA, UT028DA, and UT028CB) and 25-packs (lot number UT030CA). The strength of vaccines can sometimes decline with time, the agency said in a statement on its Web site. Children who were vaccinated with the weakened doses should not be revaccinated because the antigen content “is only slightly below the ‘specified’ range,” the CDC said. That level is still expected to protect against H1N1.