notyard
12-20-2007, 07:41 AM
U.S. FDA recall press release on select lots of Merck flu vaccines:
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.
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.