December 13, 2007
Merck has issued a voluntary recall of one million doses of its Haemophilus influenzae type b vaccine, an action that the CDC said does not threaten public health but will cause a serious vaccine shortage.
Merck decided to recall the vaccines after tests at a manufacturing plant in Pennsylvania identified a malfunction in the sterilization process that could have allowed microorganisms to survive the process.
Both the CDC and the FDA emphasized that they have no evidence of contaminated vaccine, nor have there been any reports of adverse events associated with use of the suspect vaccines.
Moreover, the recall does not affect potency so there is no need for revaccination of children who received vaccinations from the affected lots.