Merck and Co. Inc, has announced a voluntary recall of approximately 1 million doses of Hib containing vaccine, including 10 lots of PedvaxHIB, and two lots of COMVAX.

Health care professionals are advised not to administer any vaccine from the vaccine lots being recalled. Affected doses were distributed starting in April 2007 and are listed below:

PRODUCT DESCRIPTION	LOT #	EXP. DATE
PedvaxHIB®	0677U	11 January 2010
PedvaxHIB®	0820U	12 January 2010
PedvaxHIB®	0995U	16 January 2010
PedvaxHIB®	1164U	18 January 2010
PedvaxHIB®	0259U	17 October 2009
PedvaxHIB®	0435U	18 October 2009
PedvaxHIB®	0436U	19 October 2009
PedvaxHIB®	0437U	19 October 2009
PedvaxHIB®	0819U	09 January 2010
PedvaxHIB®	1167U	10 January 2010
COMVAX®	0376U	05 January 2010
COMVAX®	0377U	08 January 2010

If you have the affected lot numbers, you should contact your vaccine supplier for details on returning any of the above recalled vaccine. Note that children who may have already received the recalled vaccine do not need to be re-vaccinated.

There is currently no evidence that the above lots of vaccine are ineffective. However, Merck cannot verify the sterility of the vaccine, and therefore cannot rule out an increased risk of localized or disseminated infections. No infections have been reported so far in relation to these vaccines.

While infections are unlikely, they would almost certainly occur within seven days of vaccine receipt. Anyone developing an infection after vaccination should be reported using the federal Department of Health and Human Services (HHS) Vaccine Adverse Event Reporting system at 1.800.822.7967 (or at www.vaers.hhs.gov).

For more information about the recall, Merck has put together this Q&A and this letter to health care professionals. Additionally, health care professionals who have any questions regarding the recall should contact their local health department. Click here for your local health department contact information.