Class 3 Medicines Recall: Accord Healthcare Ltd, Ipratropium Bromide 500 microgram / 2ml Nebuliser Solution, EL(25)A/45
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
Ipratropium Bromide 500 microgram / 2ml Nebuliser Solution
PL: 20075/0692
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.
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 their 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.
Recipients of this Medicines Recall 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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