Urgent Recall of Ventolin and Seretide Accuhaler Inhalers Due to Manufacturing Defect

Urgent Recall of Ventolin and Seretide Accuhaler Inhalers Due to Manufacturing Defect

Mar, 23 2024

In a significant announcement affecting asthma patients across the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued a recall for select batches of Ventolin Accuhaler and Seretide Accuhaler devices. This recall is a precautionary measure to ensure the health and safety of patients who rely on these inhalers for asthma management. It's vital that those affected by this recall act swiftly to replace their inhalers to avoid any potential disruption to their treatment.

The recall specifically targets three lots of asthma inhalers due to a manufacturing issue. The identified lots include two batches of Ventolin Accuhaler, with lot numbers 786G and 754P, both due to expire in May 2019, and a batch of Seretide Accuhaler, lot number 5K8W, set to expire in April 2019. The defect in question could result in a small number of devices failing to deliver the full amount of doses contained within the inhaler.

Patients currently in possession of Ventolin Accuhaler units from the impacted lots are advised to immediately contact their pharmacist to arrange a replacement. As Ventolin is often used on an as-needed basis, it is imperative for patients to have a fully functional inhaler available at all times. Conversely, the Seretide Accuhaler, typically used for maintenance treatment of asthma, is being recalled at the pharmacy level, suggesting that patients may not need to take immediate action themselves but should be aware of the recall.

It's reassuring to note that this recall does not affect other asthma inhalers, including the Ventolin Evohaler, which remains a staple treatment for asthma sufferers worldwide. This specificity in the recall underscores the importance of checking your inhaler's lot number and expiry date to determine whether your device is affected.

Bernadette Sinclair Jenkins, MHRA’s Regulatory Assessment Unit Manager of the Inspections, Enforcement and Standards unit, highlighted the importance of this recall. Jenkins emphasized the safety and efficacy of treatments as a top priority. She has encouraged patients and healthcare providers to rigorously check their inhalers and report any issues encountered, not just with asthma inhalers but with all medical devices, to the MHRA via the Yellow Card scheme. This reporting mechanism is crucial for the ongoing monitoring and safety assurance of healthcare products.

For any concerns or queries regarding the recall, patients can reach out to GSK's Customer Support Team. Communication can be initiated via email at [email protected] or by calling 0800 221 441 (option 4). This line of communication is essential for obtaining the most current information and guidance on how to proceed if one possesses an inhaler from the affected lots.

Moreover, the specific lot codes and expiration dates of the recalled products are as follows:

Product DescriptionLot DetailsFinal MarketExpiry Date
Ventolin 200mcg – Accuhaler 1x60D786GUK05/2019
Ventolin 200mcg – Accuhaler 1x60D754PUK05/2019
Seretide 50/250mcg - Accuhaler 1x60D5K8WUK04/2019

The ramifications of using an impaired inhaler can be significant for asthma sufferers. Asthma, a chronic respiratory condition, requires consistent and effective management to ensure that individuals can lead a normal, active life. An malfunctioning inhaler could potentially lead to inadequate control of asthma symptoms, highlighting the critical nature of this recall.

Patient safety and medication efficacy are the cornerstone of robust healthcare. This recall, while posing a logistical challenge for both patients and healthcare providers, also serves as a reminder of the rigorous quality standards that pharmaceutical products must meet. It underscores the importance of continuous monitoring and quality assurance processes in the pharmaceutical industry. Patients impacted by this recall should take immediate steps to secure a replacement inhaler, while also remaining vigilant for any future notices pertaining to their medication.

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