Sanofi/Daiichi Sankyo recall hemophilus flu vaccine ActHIB due to contamination

French pharma major Sanofi-Aventis’ (Euronext: SAN) Japanese vaccines subsidiary and Japan’s second-largest drugmaker Daiichi Sankyo (TYO: 4568) have decided to voluntarily recall batches of ActHIB (hemophilus influenza type b conjugate vaccine) which are manufactured and marketed by Sanofi Pasteur KK and distributed by Daiichi Sankyo 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 (non-bacterial). 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 last Friday.

Sanofi Pasteur says it will endeavor to find the cause of this matter and prevent recurrences of the incidence by reviewing quality measures at the production stage.