GlaxoSmithKline recalls respiratory inhalers from 9 markets outside the U.S.

GSK building
GlaxoSmithKline is recalling Ventolin inhalers in the U.K. and Canada for manufacturing issues that affect the number of doses the inhalers give out.

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.

Webinar

Use Serialization Data to Maximize Performance and Minimize Risks

Wednesday, March 18 | 11am ET / 8am PT

Serialized products generate a wealth of data as they move through the supply chain. What if you could access and analyze this data to gain operational visibility and powerful business insight? It’s time to put your serialization investment to work for you.

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. 

RELATED: GlaxoSmithKline Ventolin recall hits 1.1M units as drugmaker retrieves half-million more

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.

RELATED: GlaxoSmithKline eyes $1.7B bid for respiratory partner Vectura: report

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.

Suggested Articles

Fujifilm Diosynth Biotechnologies last year committed 10 billion yen toward its manufacturing operations. It has now kicked off one of those projects.

Popular logic says you never switch horses, or CDMOs, in the middle of the stream, but Acacia Pharma had to do that to win an FDA approval.

The FDA has found issues with the testing practices of a U.S. generics maker that had specific problems with ADHD and weight-loss drugs.