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Some pediatric doses of influenza A (H1N1) vaccine recalled
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Officials with Sanofi Pasteur announced today that they are recalling about 800,000 doses of the influenza A (H1N1) vaccine, that were intended to be used for children aged 6 months to 3 years.
Recent quality assurance testing of the 0.25 mL doses of the monovalent vaccine indicated that the amount of antigen content was lower than required potency levels, health officials said in a statement.
CDC and FDA officials reported that the small decrease in antigen content is not likely to result in a clinically significant reduction in immune response among vaccinees, and the agencies are not calling for revaccinations.
Providers are being asked to return any remaining vaccine to the manufacturer from the four lots. For 0.25 mL pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25), the following lots have been recalled:
- UT023DA
- UT028DA
- UT028CB
For 0.25 mL pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70), lot UT030CA has been recalled.