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Merck Recalls Certain Lots of Haemophilus influenza type b (Hib) Vaccine

Merck & Co. has initiated a voluntary recall in the United States for certain lots of PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] and certain lots of COMVAX® [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine]. The affected doses were distributed in the U.S. starting in April 2007.

The lots that are being recalled are:

• PedvaxHIB, Lot# 0677U, Expiration Date: 11 January 2010
• PedvaxHIB, Lot# 0820U, Expiration Date: 12 January 2010
• PedvaxHIB, Lot# 0995U, Expiration Date: 16 January 2010
• PedvaxHIB, Lot# 1164U, Expiration Date: 18 January 2010
• PedvaxHIB, Lot# 0259U, Expiration Date: 17 October 2009
• PedvaxHIB, Lot# 0435U, Expiration Date: 18 October 2009
• PedvaxHIB, Lot# 0436U, Expiration Date: 19 October 2009
• PedvaxHIB, Lot# 0437U, Expiration Date: 19 October 2009
• PedvaxHIB, Lot# 0819U, Expiration Date: 09 January 2010
• PedvaxHIB, Lot# 1167U, Expiration Date: 10 January 2010
• PedvaxHIB, Lot# J2438, Expiration Date: 24 October 2009
• COMVAX, Lot# 0376U, Expiration Date: 05 January 2010
• COMVAX, Lot# 0377U, Expiration Date: 08 January 2010

No other lots of PedvaxHIB® or COMVAX®, and no other Merck products, are affected by this recall.

Why are these lots being recalled?

Merck is taking this step as a precautionary measure. The company cannot assure sterility for these specific vaccine lots. The potential contamination in these specific lots was identified as part of Merck's standard evaluation of their manufacturing processes. In routine testing of the vaccine manufacturing equipment used to produce PedvaxHIB® and COMVAX®, Merck identified the presence of a certain bacteria called Bacillus cereus. Sterility tests of the vaccine lots themselves have not found any contamination.

The potential for contamination of any individual vaccine is low, and, if present, the level of contamination would be low. However, because they cannot guarantee the sterility of these specific lots of vaccine, Merck is conducting this recall.

For More Information

Questions and Answers about Hib Recall
www.cdc.gov/vaccines/recs/recalls/hib-recall-faqs-12-12-07.htm

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Date Posted: December 13, 2007

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