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Publication #8412
Reference
Drug alert 12/2025
Name
Drug Alert Class 4 Drug Alert 12 2025 – Class 4 medicines recall – caution in use – Cross Healthcare Ltd – Sirdupla 25mcg/250mcg per metered dose pressurised inhalation suspension
Categories
Scottish Government
Drug Alerts
Organization
Scottish Government Health and Social Care Directorates
Keywords
NHS
Scotland
Drugs
Safety
Risks
Pharmaceutical Industry
Medicines Recall
Description
Cross Healthcare Limited have informed the MHRA that there is a printing defect on the outer labels for the Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension, batch 77518.
There is 5mm of missing text on the left-hand side of the outer label, please refer to the image in this notification for more information.
The defect is restricted to the outer label on the front face of carton, which is applied onto the carton by Cross Healthcare Limited following importation.
The product is as specified, Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension.
All other labels and the Patient Information Leaflet specify the correct information for Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension. The labelling defect has no impact on the medicinal product which can continue to be distributed, prescribed, dispensed and used.
Contact Name
Irene Fazakerley
Contact Email
Contact Address
Contact Phone
Created
2025-03-31 15:44:00
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