GSK has withdrawn another lot of its Infanrix Hexa vaccine over concerns about potential microbial contamination.
The latest recall - of lot Lot A21CB242A - was announced the recall in a letter sent to Health Canada last week , explaining that: “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.”
The move follows just weeks after the UK drug major recalled six lots of the vaccine in Australia, again citing contamination problems as the motivation for the move.
At the time the firm said it had “identified that one step of the vaccine manufacturing process was found to have a low level contamination.”
A notice on the Therapeutic Goods Administration (TGA) website indicates that GSK detected a small amount of the bacterium Bacillus cereus on a surface where one of the manufacturing steps takes place.
GSK confirmed this and told in-Pharmatechnologist.com that all of the recalled vaccine lots were made at the firm's manufacturing facility in Rixensart, Belgium and that the motivation for both the withdrawals was the same.
“Testing has identified one component of the vaccine used in certain batches of Infanrix was stored in an area subsequently found to have a low level of contamination with Bacillus cereus.
The firm added that: “GSK has voluntarily implemented a Class 1 recall for the affected batches. This is a precautionary measure, as no contamination was found in the affected batches themselves.”
GSK also said that the recall impacts the following countries: Albania, Australia, Belgium, Brazil, Canada, Cyprus, Czech Republic, France, Germany, Greece, Lebanon, Malaysia, Malta, the Netherlands, Qatar, Romania, Slovakia, Spain, the UK and Vietnam.
The vaccine is used to protect children against diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type B diseases.