GSK to supply US with Ventolin from French plant after production halt at Zebulon
The move follows a day after GSK recalled 128,704 Ventolin HFA (albuterol sulfate) inhalers made at the US site.
The firm told the US Food and Drug Administration (FDA) the withdrawal - which applies to the US only - was prompted by concerns that some product canisters may not contain sufficient propellant to deliver 200 doses.
Spokesman Juan Carlos Molina told us GSK “received product complaints of the sealed foil overwrap being inflated on certain Ventolin HFA units” which he said prompted the recall and the decision to temporarily cease production of the product at Zebulon.
The firm is still investigating the cause of the problem, however, Molina suggested that “leakage from the unit can cause the overwrap or “pouch” to inflate.”
He also said GSK intends to supply the US market with Ventolin HFA inhalers produced at a facility in Evreux, France until it can restart operations as Zebulon.
North Carolina in 2015
The Zebulon site has been in the news already this year.
In August, GSK briefly halted production after discovered legionella bacteria in one of its cooling towers.
Manufacturing operations restarted a few days later.
Unlike the earlier shutdown, the current halt is limited to Ventolin HFA.
Production of other GSK medicines made at the facility – including respiratory drugs like Advair, Breo, and Ellipta as well as products such as Potiga, Valtrex and Lamictal – will continue.
