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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] and COMVAX [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine]-Merck & Co., Inc.

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


DATE RECALL INITIATED:

December 11, 2007

PRODUCT / LOT NUMBER / EXPIRATION DATE:

 

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
PedvaxHIB®                     J2438 24     October 2009
COMVAX®                         0376U 05     January 2010
COMVAX®                         0377U 08     January 2010

 

MANUFACTURER:

Merck & Co., Inc.
West Point, PA

REASON:

These lots of PedvaxHIB and COMVAX are being recalled due to lack of assurance of product sterility.

Related Information:

MedWatch: PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] COMVAX [Haemophilus b Conjugate (Menigococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine] - 12/13/2007


FDA Consumer Update: Merck Recalls Certain Lots of Haemophilus influenza type b (Hib) Vaccine

Interim Recommendations for the Use of Haemophilus influenzae Type b (Hib) Conjugate Vaccines Related to the Recall of Certain Lots of Hib-Containing Vaccines (PedvaxHIB® and Comvax®) - MMWR - 12/19/2007

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002