Voluntary recall of hemophilus influenza type b conjugate vaccine "ActHIB®"

Voluntary recall of hemophilus influenza type b conjugate vaccine "ActHIB®"

To the attention of the Press :
March 11, 2011
Sanofi Pasteur KK
Daiichi Sankyo Co., Ltd.

Sanofi Pasteur KK (Head Office: Shinjuku-ku, Tokyo; Representative Director and President: Franck Perraudin, hereinafter "Sanofi Pasteur") and Daiichi Sankyo Co., Ltd. (Head Office: Chuo-ku, Tokyo; Representative Director and President and CEO: Joji Nakayama, hereinafter "Daiichi Sankyo") have decided to voluntarily recall part of the products "ActHIB®" (generic name: hemophilus influenza type b conjugate vaccine) which are manufactured and marketed by Sanofi Pasteur and distributed by Daiichi Sankyo. This voluntary recall of some ActHIB products is due to a notification of contamination by foreign matter and the resulting investigation which confirmed two cases of contamination inside syringes of diluent which are used to reconstitute ActHIB.
As a result of analysis of information by Sanofi Pasteur up to the present time, it has been confirmed that the foreign matter was aseptic (nonbacterial). However, in order to eliminate every possible risk, it was decided to voluntarily recall the ActHIB products which were manufactured in the same manufacturing process as the syringes in which the foreign matter was confirmed starting today.
Please allow us to express our sincere apologies for the inconveniences and concern this recall may cause to health professionals and families of infants eligible for immunization with "ActHIB®." Sanofi Pasteur will endeavor to find the cause of this matter and prevent recurrences of the incidence by reviewing quality measures at the production stage. Your understanding of the present voluntary recall would be much appreciated.
Lot numbers of products subject to recall:
E0771
E1174
E0962
E1065
E1235
E1201
G1030
E0897
E1200
E1033
E1160
E1236
G1018
-end-
Inquiries:
Sanofi Pasteur KK
Vaccine Advocacy and Public Affairs
Masumi IWAMA
Tel: 03-6301-3089
Daiichi Sankyo Co., Ltd.
Corporate Communication Department
Tel: 03-6225-1126

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