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 name
GoResp Digihaler, PLGB 00289/2501
SNOMED Code
42007211000001108
| Batch No | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| AGD11A | 04/2026 | 160/4.5mcg (180 dose) | 18/07/2023 |
GoResp Digihaler, PLGB 00289/2502
SNOMED Code
42007511000001106
| Batch No | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| AGD12A | 04/2026 | 320/9mcg (90 dose) | 18/07/2023 |
Active Pharmaceutical Ingredient: Budesonide/Formoterol Fumarate Dihydrate
Brief description of the 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 The inhalers containing the medicinal product are being withdrawn from the market because the App is no longer being supported, there is no product quality issue with the medicine itself.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 for 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 for 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.
Further information
For medical information, please contact medinfo@tevauk.com (Tel. 02075 407117) and stock control enquiries please contact customer.services@tevauk.com (Tel. 0800 590502).
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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