Medication recall: Ventolin and Asmol (salbutamol) inhalers (certain batches only)
Published in Health News and Evidence
Date published: About this date
A fault in the delivery mechanism of certain batches of Ventolin and Asmol 100 mcg/200 metered-dose inhaler (MDI) may result in less than the full dose of medicine being delivered for each puff.1 GlaxoSmithKline (GSK) and Alphapharm, in consultation with the Therapeutic Goods Administration, are undertaking a voluntary recall of affected batches after receiving complaints about reduced effectiveness of some inhalers.1
Both products are manufactured by GSK. In Australia, Ventolin is distributed by GSK and Asmol is distributed by Alphapharm.2,3 The companies estimate that approximately 25,000–50,000 inhalers from the affected batches are involved in this recall. Approximately 900,000 of these products are distributed each month. Other batches are not affected by this recall.1
- This recall only applies to certain batches of Ventolin and Asmol metered-dose inhaler (MDI)
- GSK has conducted an investigation and actions to rectify the problem are being implemented
- Identify patients using affected batches by checking, or asking them to check, the batch number
- Patients with worsening symptoms may be using affected batches
- Advise patients with affected batches to obtain a replacement from their pharmacist
To find the batch number on the inhaler, remove the canister from the coloured tube. It is located on the bottom of the canister label.1
|Ventolin batch numbers||KN7170, KN7173, KN7178, and KN7179|
|Asmol batch numbers||KL6790, KL6795, KL6796, KL6797, KL6798, and KL6799|
How do I identify patients using an affected batch?
Check, or ask your patient to check, the batch number on their inhaler.1
Patients presenting with worsening respiratory symptoms may be taking a sub-therapeutic dose of salbutamol from an affected inhaler.1 Symptoms may otherwise be due to worsening of the patient’s airways disease,1 poor compliance and inadequate inhaler technique.4
What are the risks if patients do not obtain a replacement of their affected batch?
In most cases the overall risk to the patient is low.2,3 However, as Ventolin/Asmol MDI are sometimes used to treat acute asthma or exacerbations of chronic obstructive pulmonary disease, sub-therapeutic doses could pose a serious risk to health.1,4
Is it safe for patients to continue using an affected batch?
Advise patients to obtain a replacement of their affected inhaler from their pharmacist. However those using affected inhalers may still be adequately treated. Some patients may need to take 1–2 extra puffs to get the expected effect from their usual dose.1 It is safe for patients to take an additional 1–2 puffs from their inhaler as salbutamol has a wide therapeutic index.3 In acute asthma, adults may take up to 6–8 puffs every 5 minutes.4
This recall only applies to the affected batches.1
|If you are required to confirm the relevant batch number remove the canister from the coloured tube||The batch number is located on the bottom of the canister label.1|
|If you have an inhaler from an affected batch||You may return it to your pharmacy for a replacement at no cost.1|
|If you continue to use an inhaler from an affected batch||You may still be adequately treated.1 You may need to take 1–2 extra puffs to get the expected effect from your usual dose.If your symptoms do not respond in the usual way consult your doctor.1|
|If you do not have an inhaler from an affected batch||Continue to use it as instructed by your doctor and in accordance with your asthma management plan.1|
|If you have symptoms that are getting worse, and not responding to your usual treatment||Seek medical attention.1|
|GlaxoSmithKline (GSK) has conducted an investigation||All pharmacists, doctors, respiratory physicians and wholesalers have been advised of the situation. Actions are being taken to ensure this fault does not occur again|
|GSK conducted a medical assessment of the risk/benefit impact of the situation||The assessment determined that the overall risk to patients is low|
|Pharmacies may return affected stock to their primary wholesale supplier of Ventolin/Asmol||Pharmacies will have affected stock replaced at no charge|
|Doctor’s supplies including emergency supplies or product samples may be returned to pharmacies||Doctors may have their supplies replaced at no charge|
- Further information for both consumers and health professionals from the Therapeutic Goods Administration
- GSK recall letters for pharmacists and health care professionals
- Consumer medicine information: Ventolin CFC-free Inhaler
- Australian Government Department of Health and Ageing: Therapeutic Goods Administration. Ventolin and Asmol (salbutamol)CFC-free MDI 100 mcg/200 doses inhalers (certain batches only). December 2012. http://www.tga.gov.au/safety/alerts-medicine-ventolin-asmol-121224.htm (accessed 3 January 2013).
- GlaxoSmithKline. UrgentMedicine Recall (Pharmacist). 2012. http://www.racgp.org.au/download/Documents/Media/ventolin___asmol_hcp_pharmacy_letter_-_21.12.12-_v1.pdf
- GlaxoSmithKline. UrgentMedicine Recall (Healthcare professional). 2012. http://www.racgp.org.au/download/Documents/Media/ventolin___asmol_hcp_recall_letter_-_21.12.12-_v1.pdf (accessed 3 January 2013).
- Australian medicines handbook. Adelaide: Australian Medicines Handbook Ltd, 2012.