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 Number: DMRC - 37371169

Company name:Accord Healthcare Limited.

Product description: Ipratropium Bromide 500 microgram / 2ml Nebuliser Solution

PL: 20075/0692

Active Ingredient: Ipratropium bromide

SNOMED code: 11006411000001107

Details of the affected batch:

Background information: 

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 to 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.

Company contacts for further 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.

To access the full recall/alert: 

Class 3 Medicines Recall: Accord Healthcare Ltd, Ipratropium Bromide 500 microgram / 2ml Nebuliser Solution, EL(25)A/45