Class 4 Medicines Defect Notification: Cross Healthcare Ltd, Sirdupla EL(25)A/12

Class 4 Medicines Defect Notification: Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension, EL(25)A/12

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.

DMRC Number: 34709021

Company name: Cross Healthcare Limited

Product description: Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension, PLPI: 20504/0109

Details of the affected batch: 

Brief description of problem:

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.

Please see the Recall document for an image of the product.

Advice to Healthcare Professionals:

Healthcare Professionals are advised that if a unit is identified with this printing defect:

• The quality and efficacy of the medicinal product is not impacted by this defect and can continue to be prescribed, dispensed and used, as appropriate.
• The printing defect is restricted to the outer label shown in the image in this notification, all other labels and Patient Information Leaflet contain no printing defects and are compliant to PLPI 20504/0109.
• Reassure any concerned patients that this is a labelling defect only and that the product is Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension. Where necessary show them other labels or the Patient Information Leaflet that do not contain this error.

Advice to Patients:

Patients should continue to take medicines from the impacted units of batch 77518 as prescribed by your healthcare professional as the defect is restricted to the specific defect shown on the image in this notification.

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

For further information please email gary@crosshealthcare.co.uk or telephone 01786 817707.

To access the full recall: Class 4 Medicines Defect Notification: Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension, EL(25)A/12