24 Dec 2012 - Voluntary recall - ten batches of Ventolin and Asmol Inhalers
GlaxoSmithKline (GSK) is initiating a retail level recall of 10 batches of Ventolin and Asmol Inhalers due to a fault in the delivery mechanism leading to an inconsistent dose.
In devices which are affected, the dose of salbutamol may not be delivered in full. Although the medicine is effective over a wide range of doses, it is possible that this fault could reduce the effectiveness of the medicine. However, a medical assessment has determined that the overall risk to patients is low.
Patients with an impacted puffer can return it to their pharmacy for a free replacement.
“Healthcare professionals have been advised of the situation and have been asked to apply clinical judgement should a patient experience a worsening of their asthma,” said Dr. Andrew Yeates, Medical Director GlaxoSmithKline Australia.
As the manufacturer, GSK has conducted a thorough investigation and appropriate actions are being taken to ensure that this situation does not occur again.
Patient safety, quality and continued supply of medication to patients are key objectives of GSK and Alphapharm and we remain committed to meeting requirements of the Australian patients.
Batches affected are:
VENTOLIN batch numbers: KN7170, KN7173, KN7178, KN7179
ASMOL batch numbers: KL6790, KL6795, KL6796, KL6797, KL6798, KL6799
This batch recall does not affect any other delivery forms of Ventolin and Asmol or other respiratory medicines supplied by either company.
To confirm the relevant Batch Number, the canister needs to be removed from the tube and the Batch Number is located on the bottom of the canister label.
In Australia, this product is distributed by GSK - Ventolin® and Alphapharm - Asmol®.
For more information please contact GSK Medical Information on 1800 064 162.
For more information on Ventolin, please visit www.gsk.com.au and Asmol www.alphapharm.com.au
Tel: + 61 3 9721 6637
Mobile: +61 449 950 745