GlaxoSmithKline is again having issues with the manufacturing of some of its respiratory inhalers, leading it to voluntarily recall some products in the U.K. and eight other markets, but not in the U.S.
A spokesman in an email said GSK is voluntarily recalling four lots of Ventolin (Diskus/Accuhaler) and seven lots of Seretide (Diskus/Accuhaler) devices.
The issue, which occurred during the assembly of the devices, involved a foil strip containing the medicine inside the device which may have been damaged, reducing the full number of doses the inhaler may deliver. The issue, which affected one day of production or about 200,000 units, has been fixed, he said. The inhalers were assembled in June of last year at GSK’s site in Evreux, France.
The Ventolin Diskus inhalers were recalled to the patient level in the U.K., Canada and the Netherlands, while the Seretide Diskus inhalers were recalled from hospitals, pharmacies and wholesalers in the U.K., Austria, Finland, Lithuania, Gibraltar, France and Morocco.
GSK said the issue was different from one that led to the recalls of hundreds of thousands of Ventolin inhalers in the U.S. last year. GSK pointed out at the time that although the numbers appeared large, those recalls amounted to just about 4% of total U.S. annual Ventolin volume. Those inhalers were manufactured at GSK’s plant in Zebulon, North Carolina.
Ventolin is an older product with slipping sales, down 2% to £767 million ($1.02 billion) last year, but GSK continues to invest in its production. The U.K.-based drugmaker last year indicated it would invest about £110 million ($137 million) in a new facility at a site in Scotland for the production of salbutamol, the API in Ventolin.
The recalls come even as Glaxo is reported to be considering a bid for Vectura, with which it partners on some respiratory therapies, but which also is working on a generic version of GSK’s top-selling Advair. GSK has licensed Vectura's technology for products such as Breo and Anoro, and Vectura boasts some “smart inhaler” technology that GSK may be interested in.