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Ventolin and Asmol (salbutamol) CFC-free MDI 100 mcg/200 doses inhalers (certain batches only)

Medicine recall

24 December 2012

GlaxoSmithKline (GSK) and Alphapharm, in consultation with the TGA, are undertaking a voluntary recall of several batches of Ventolin and Asmol inhalers due to a fault in the delivery mechanism of a small number of inhalers within each batch. This can lead to less than the full dose being delivered for each puff.

The only batches affected are as follows:

  • Ventolin Batch numbers KN7170, KN7173, KN7178, and KN7179
  • Asmol Batch Numbers KL6790, KL6795, KL6796, KL6797, KL6798, and KL6799

Information for patients

If you have an inhaler from an affected batch you may return it to your pharmacy for a replacement.

If you have an inhaler from an affected puffer within an affected batch, the dose delivered may still treat your asthma symptoms. You may need to take 1 - 2 extra puffs to get the expected effect from your usual dose. If the symptoms do not respond in the usual way you should consult a doctor.

Patients are advised that this notice only applies to the affected batches. If you do not have an inhaler from an affected batch, continue to use it as instructed by your doctor or in accordance with your asthma management plan. If you have symptoms that are getting worse, and not responding to your usual treatment seek medical attention.

How to identify if your medicine is affected

To find the batch number on your inhaler, please remove the canister from the coloured tube and the batch number is located on the bottom of the canister label.

Information for Health Professionals

Patients presenting with worsening respiratory symptoms, and who are using the affected inhalers, may have symptoms attributed to this recall. Alternatively, the symptoms may be due to underlying worsening of the patient’s airways disease.

About Ventolin and Asmol

Ventolin and Asmol Inhalers are used to treat asthma or chronic obstructive pulmonary disease (such as emphysema or chronic bronchitis).

About the recall

GlaxoSmithKline and Alphapharm, the companies received complaints from users about a reduced effectiveness of some inhalers.

The companies estimate that approximately 25,000 - 50,000 inhalers from the affected batches are estimated to be involved in this recall. Approximately 900,000 of these products that are distributed each month. Other batches are not affected by this recall.

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Content last updated: Monday, 24 December 2012

Web page last updated: Monday, 4 February 2013

URL: http://www.tga.gov.au/safety/alerts-medicine-ventolin-asmol-121224.htm