Less than a week after GSK Canada said that it had recalled a lot of Ventolin Diskus in Canada due to “a manufacturing issue that may result in a small number of Ventolin Diskus devices not delivering the full number of doses in the device,” the MHRA announced a recall of 2 lots of Ventolin Accuhaler and 1 lot of Seretide Accuhaler in the UK due to the same issue. Recall notices for both products were published on the MHRA website as of 21 February, 2018.
GSK has also confirmed to OINDPnews that certain lots of Ventolin Diskus have been recalled from patients in the Netherlands as well as in the UK and Canada, and some lots of Seretide Diskus have been recalled from hospitals, wholesalers, and pharmacies in Austria, Finland, Lithuania, Gibraltar, France, and Morocco as well as in the UK.
In total, 4 lots of Ventolin Diskus and 7 lots of Seretide Diskus were recalled. The inhalers involved in the recalls were manufactured in a single day at GSK’s Evreux, France facility, and the issue has been resolved. Ventolin HFA inhalers are not involved in the current recall.
While Fierce Pharma reported those recalls on 22 February, 2018, GSK has yet to issue a statement covering the extent of the recall as of 26 February. On its US site, GSK posted a statement denying reports that there had been a recall of Ventolin HFA; that statement makes no mention of the Ventolin and Seretide Diskus recalls in other markets.
View the MHRA notice on the Ventolin Accuhaler recall.
View the MHRA notice on the Seretide Accuhaler recall.
