MHRA Class 3 Medicines Recall: Ipratropium Bromide 500 microgram / 2ml Nebuliser Solution (Accord Healthcare Ltd)
Drug Alert Number: EL(25)A/45
Date issued: 23 October 2025
Accord Healthcare Ltd is recalling a batch of Ipratropium Bromide 500 microgram/2ml Nebuliser Solution after a foil pouch was found to contain ampoules with incorrect labels intended for the Korean market. The incorrectly labelled ampoules are the same product and contain the same active ingredient but have Korean language labels and different batch details.
DMRC reference number: DMRC – 37371169
Marketing Authorisation Holder: Accord Healthcare Limited.
Medicine Details
Product name: Ipratropium Bromide 500 microgram / 2ml Nebuliser Solution (PL: 29831/0195)
Active ingredient: Ipratropium bromide
SNOMED code: 11006411000001107
GTIN: 05055565739587
Affected Lot Batch Numbers:
| Batch No. | Expiry Date | Pack Size | First Distributed |
| UK25B06 | 31/03/2028 | 20 ampoules | 04/07/2025 |
Background
Accord Healthcare Ltd is recalling the above batch after a foil pouch was found to contain ampoules with incorrect labels intended for the Korean market. The incorrectly labelled ampoules are the same product and contain the same active ingredient but have Korean language labels and different batch details.
Advice for healthcare professionals
Stop supplying the above batch immediately.
Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
View full alert here.
Advice for Healthcare Professionals to Provide to Patients
No action is required by patients as this recall is being undertaken at a Pharmacy and Wholesaler level.
Patients who have taken the mislabelled ampoules will have received the correct medication as it is the same product but with labels intended for the Korean market.
If you have concerns about this, contact your dispensing pharmacist in the first instance.
Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Additional Information
For all medical information enquiries and information on this product, please email Accord-UK Medical Information Department medinfo@accord-healthcare.com, or telephone 01271 385257.
For stock control enquiries please email Accord-UK Customer Services Team customerservices@accord-healthcare.com, or telephone 0800 373573.
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