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