GSK hit by recall of 600,000 inhalers

pharmafile | April 5, 2017 | News story | Manufacturing and Production, Research and Development FDA, GSK, Ventolin 

The FDA has released that GSK would be voluntarily recalling close to 600,000 of its Ventolin asthma inhalers across the US. The reason for the recall was disclosed as being related to a leak observed in some of the products.

The leak of the propellant that delivers the medicine is not serious enough to require an extension to consumers but instead means that the products will be withdrawn from hospitals, pharmacies, retailers and wholesalers. The upshot of the defect is that the affected devices will not be able to deliver the full 200 doses.

The exact number of the inhalers to be recalled was reported by the FDA as 593,088 and were produced in GSK’s Zebulon, North Carolina manufacturing facility. It is the second time in just over a year that the plant has faced problems with leaking inhalers.

Back in December 2015, production of the inhalers had to be stopped after the same issue was found in devices produced at the plant. The pause in production meant that inhalers had to be supplied from GSK’s French plant, in Evreux, to act as a stop-gap.

There is no suggestion as yet that production will have to stop as a result of this most recent issue. The recall was initiated on 22 March and is on-going.

“We currently don’t anticipate a supply impact to Ventolin HFA 200D inhaler as a result of this issue,” GSK said in a statement”.

Ben Hargreaves

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