30 Jul 2004 - Limited Seretide Accuhaler recall
(Not intended for US media)
Check Seretide Accuhaler 500/50 mcg. Batch no B122140 RECALL
GSK is committed to providing safe, effective and high quality medicines to the Australian community. The company has identified that some dry powder Accuhalers in a single batch of Seretide 500/50 mcg have a defect in the foil strip containing the active medicine within the Accuhaler.
Patient safety is our first concern and, while the number of Accuhalers with the potential to be impacted is low, GSK is voluntarily undertaking a patient level recall.
Seretide is a medicine used in the regular treatment of asthma. Seretide is a combination product, which contains both an inhaled corticosteroid and an inhaled long-acting beta 2 agonist in a single Accuhaler.
The likelihood of a patient receiving a faulty inhaler is low as only a small number of Accuhalers in a single batch have the potential to be affected, and not all affected Accuhalers will malfunction. In some circumstances this defect could mean that a patient may not receive the medicine they require to control their asthma.
GSK has carried out an investigation into the cause of the problem. This defect was a consequence of an isolated incident on one single batch manufactured. The company has taken immediate actions in order to ensure this does not recur.
Patients who have a Seretide 500/50 mcg Accuhaler should check the batch number by looking at the back of the Accuhaler and locating the batch number. If it corresponds with batch number B122140 exp 04/05 patients are advised to take the Accuhaler to their pharmacist where they will receive a replacement at no cost.
It is important that patients do not cease using any respiratory medication without consulting their medical practitioner first. Continued supply of medication to patients is a key objective of GSK and we are confident that patient supply will not be interrupted by this recall activity.
For Product Information regarding GSK products or to report an adverse event please call Medical Information on 1800 033 109.
Contact: Nikki Capp 03 9721 6730
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Updated Friday, 24 September 2004 © 2001-2004 GlaxoSmithKline Australia Pty Ltd (ABN 47 100 162 481) - All Rights Reserved
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