Daiichi Sankyo announced it will recall 13 lots in Japan of a Sanofi Pasteur ActHIB vaccine--whose use has been suspended in the country--due to an unidentified substance found in two syringes. Japan officials have cleared the vaccine, and Pfizer's Prevnar, after investigating the vaccines' role in six children's deaths.
"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)," Daiichi says in a statement. "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."
Only 200,000 doses remain of an original 1.3 million, and the companies believe the syringes may have been contaminated during the manufacturing process in 2009.