GlaxoSmithKline recently closed out a voluntary recall of 130,500 doses of its market-leading shingles vaccine Shingrix after finding cracks in two vials.
In a recall notice posted on FDA’s website, the agency notes that GlaxoSmithKline last week finished a recall it started back in February 2021. The company issued the voluntary recall early last year after one customer reported an empty antigen vial and another customer said there was an “abnormal appearance of the antigen powder in a vial,” a GSK spokesperson told Fierce Pharma.
GSK's subsequent visual investigation determined both vials had cracks. The company's "investigation determined that the issue most likely occurred during the manufacturing process and has since been resolved," she added. Ongoing supply isn't affected, she said.
Shingrix, which is GSK’s second-biggest selling product, recorded £1.72 billion ($2.26 billion) in sales last year. The company is counting on the product to drive growth and it has been working to scale up capacity in recent years.
Though GSK expects Shingrix to continue growing, the COVID-19 crisis has slowed sales due to coronavirus vaccine rollouts. To get back on track, GSK announced last June that it would essentially relaunch Shingrix by doubling its efforts in the U.S. and launching the product in about 35 countries in the coming years.