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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
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448