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AAP News Vol. 27 No. 11 November 2006, p. 2006233
© 2006 American Academy of Pediatrics
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NEWS AND FEATURES

Fluvirin influenza vaccine recall

Novartis (formerly Chiron) has issued a recovery of 5 mL multidose vials of Fluvirin vaccine shipped under the Centers for Disease Control and Prevention (CDC) contract between Oct. 11 and Oct. 17, 2006.

The vaccine was received from distributor Cardinal Health Care in a frozen state and/or below the required storage temperature. Lots 71209 and 71210 with an expiration date of June 30, 2007, are included in the recovery.

Only Fluvirin vaccine purchased through CDC contracts and shipped by Cardinal Health Care were potentially exposed to freezing temperatures.

There is no safety concern for patients who already have received this vaccine, according to the CDC. Because the vaccine potency may have been compromised due to the temperature exposure, CDC is advising pediatricians to recall patients who received the vaccine for revaccination to ensure adequate protection from influenza disease. There is no minimum interval required between doses.

Any adverse events should be documented and reported to VAERS, and recall efforts and patient response should be documented.

View the CDC notice at www.cdc.gov/flu/professionals/vaccination/fluvirinrecall06.htm, and the Food and Drug Administration recovery notice at www.fda.gov/cber/recalls/novflu102006.htm.





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