Class 3 Medicines Recall: Teva UK Limited, GoResp Digihaler, EL (24)A/23

Teva UK Limited has informed the MHRA that it plans to withdraw from further sale all batches of GoResp Digihaler (budesonide and formoterol fumarate dihydrate) and the linked Digihaler App for commercial reasons.

MDR Number: MDR 295-05/24

Company name: Teva UK Limited

Product description: 

GoResp Digihaler, PLGB 00289/2501 SNOMED Code 42007211000001108

GoResp Digihaler, PLGB 00289/2502 SNOMED Code 42007511000001106

Brief description of problem:

Teva UK Limited has informed the MHRA that it plans to withdraw from further sale all batches of GoResp Digihaler (budesonide and formoterol fumarate dihydrate) and the linked Digihaler App for commercial reasons. The inhalers containing the medicinal product are being withdrawn from the market because the App is no longer being supported, there is no product quality issue with the medicine itself.

From 1 June 2024 the Digihaler App described in the Patient Information Leaflet is no longer available for download from the Apple App Store and Google Play store. This means users will not be able to download the app, sign up, log in or load any new data.

This affects a very small number of patients who are currently using the App. However, the notification is being sent wider to ensure awareness and recall remaining stock.

Advice to Healthcare Professionals:

Stop supplying the impacted batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
If you are aware of patients using this inhaler, advise them that they should speak to their prescriber or a healthcare professional about their ongoing care. The patient can continue to use the inhaler, and the inhaler itself has a dose counter that is independent of the App, however the patient should be made aware that the App is no longer supported should it cease to function.

Advice to Patients:

No action is required by patients as this is a pharmacy and wholesaler level recall. GoResp Digihaler does not need to be connected to the App in order for you to take your medicine. The electronic module does not control or interfere with the delivery of the medication through the inhaler.

Data from the App will be retained for 10 years and can be made available to individual users of the App on request.
If you are currently using this product, please contact your prescriber or another healthcare professional about your ongoing care. The dose indicator on the inhaler is independent of the App and will still function without the App.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.

Company contacts for further information:

For medical information, please contact medinfo@tevauk.com (Tel. 02075 407117) 

For stock control enquiries please contact customer.services@tevauk.com (Tel. 0800 590502).     

To access the full recall: Class 3 Medicines Recall: Teva UK Limited, GoResp Digihaler, EL (24)A/23