Recall
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
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.