> **Voluntary Recall of Certain Lots of\
> PedvaxHIB^®^ \[Haemophilus b Conjugate Vaccine (Meningococcal Protein
> Conjugate)\] and COMVAX^®^ \[Haemophilus b Conjugate (Meningococcal
> Protein Conjugate) and Hepatitis B (Recombinant) Vaccine\] / NDC
> 0006-4897-00 and 0006-4898-00**

December 11, 2007

Dear Customer, Doctor, Healthcare Provider:

Merck & Co., Inc. ("Merck") has initiated a voluntary recall in the
United States for 10 lots of PedvaxHIB^®^ \[Haemophilus b Conjugate
Vaccine (Meningococcal Protein Conjugate)\] and two lots of COMVAX^®^
\[Haemophilus b Conjugate (Meningococcal Protein Conjugate) and
Hepatitis B (Recombinant) Vaccine\]. This letter is being written to
inform you of this recall, and to advise you not to administer any
vaccine from the vaccine lots being recalled. The lots that are being
recalled are:

  --------------------------------- ---------- --------------------------
  **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
  --------------------------------- ---------- --------------------------

The affected doses were distributed starting in April 2007. No other
lots of PedvaxHIB^®^ or COMVAX^®^ and no other Merck products are
affected by this recall.

The company is taking this voluntary action due to the fact that we
cannot assure sterility for these specific vaccine lots. The potential
contamination in these specific lots was identified as part of our
standard evaluation of our manufacturing processes. In routine testing
of the vaccine manufacturing equipment used to produce PedvaxHIB^®^ and
COMVAX^®^, Merck identified an issue that creates the potential for
microorganisms to survive the sterilization process. Specifically,
during this evaluation, Merck identified the presence of *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 we cannot guarantee the sterility of these
specific lots of vaccine, we are conducting this recall.

Based on this information, Merck recommends that you immediately
discontinue use of any of the affected lots. If an individual was
vaccinated with a vial of PedvaxHIB^®^ or COMVAX^®^ that contained *B.
cereus* or other microorganisms, there is a risk that they could develop
localized or disseminated infections. By analogy to other *B. cereus*
infections, immunocompromised individuals may be at the greatest risk
for these infections.

No potency concerns have been identified for these vaccine lots.
Individuals who received vaccine from these lots should complete their
immunization series with a Haemophilus b conjugate-containing vaccine
not affected by this recall, but do not need to be revaccinated to
replace a dose they received from a recalled lot.

Merck is working closely with the Food and Drug Administration and the
Centers for Disease Control and Prevention to inform affected customers
of this recall action. If you have purchased any of these affected lots
directly from Merck, please return the vaccine to us according to the
procedure described below; if you did not purchase directly from Merck,
please return the vaccine to your distributor. In addition, if you have
further distributed these lots of PedvaxHIB^®^ and COMVAX^®^ to other
health care providers or offices, please contact them to ensure that all
affected product is returned.

In order to ensure an effective recall and return process, it is
important that you do the following for product **purchased directly
from Merck**:

1\. Please complete the enclosed Business Reply Card and the Packing
Slip labeled \"Non-VFC Vaccine\" including entry of number of vials
returned.

2\. Mail the postage paid Business Reply Card even if you do not have
any of the product identified above to ensure accountability.

3\. Return all of the product identified above and the Packing Slip
using the prepaid Shipping Labels to:

> Stericycle, Attn: Merck Returns
>
> 2670 Executive Drive, Suite A
>
> Indianapolis, IN 46241

Credit for product will be issued at the price in effect for purchase
directly from Merck at the time of purchase.

For any Vaccines for Children (VFC) vaccine from the affected lots,
please do the following:

1\. Please complete the Business Reply Card and the Packing Slip labeled
\"VFC Vaccine\" including entry of number of vials returned.

2\. Mail the postage paid Business Reply Card even if you do not have
any of the product identified above to ensure accountability.

3\. Return all of the product identified above and the Packing Slip
using the prepaid Shipping Labels to:

> Stericycle, Attn: Merck Returns
>
> 2670 Executive Drive, Suite A
>
> Indianapolis, IN 46241

If you have both non-VFC and VFC vaccine to return, you may ship them
together in the same shipping container as long as you have accounted
for the vials separately using the appropriate forms outlined above.

Please report any potentially vaccine-related adverse experiences to the
Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 (or at
[www.vaers.hhs.gov](http://www.vaers.hhs.gov/)), and to Merck at
1-800-672-6372. If you have any questions concerning medical or other
issues, please contact the Merck National Service Center at
1-800-672-6372. The Prescribing Information for PedvaxHIB and COMVAX is
available from the Merck National Service Center or at
[www.merckvaccines.com](http://www.merckvaccines.com/).

We appreciate your immediate attention to this recall and sincerely
regret any difficulty caused by this action. Merck is committed to
resolving this issue as quickly as possible and to ensure that our full
line of vaccines is available to our customers as soon as possible.

Sincerely,

![](media/image1.jpeg){width="1.75in" height="0.7048611111111112in"}

Mark Feinberg, MD, PhD, FACP

Vice President

Medical Affairs and Policy

Merck Vaccines and Infectious Diseases

Merck & Co., Inc.

<http://www.cdc.gov/vaccines/vac-gen/shortages/downloads/hib-recall-12-12-07.doc>