After recalling 6 lots of an infant vaccine in Australia, GlaxoSmithKline ($GSK) is withdrawing another lot in Canada over concerns about potential microbial contamination.
The latest recall of Infanrix hexa vaccine is a precautionary measure, the company says. In a letter to Health Canada, GSK notes "recent investigations identified the potential for microbiological contamination in the environment where vaccine bulk antigens for Infanrix hexa, Infanrix-IPV and Infanrix-IPV/Hib vaccines were placed."
A small amount of the bacterium Bacillus cereus was found on a surface where one of the manufacturing steps takes place, in-PharmaTechnologist.com reports. All of the recalled vaccine lots were manufactured at a facility in Rixensart, Belgium, the news source says.
The vaccine protects against diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type B diseases.
- here's more from in-PharmaTechnologist.com
- read GSK's letter to Health Canada