Class 3 Medicines Recall: Accord Healthcare Ltd, Ipratropium Bromide 500 Microgram / 2ml Nebuliser Solution, El(25)a/45

Summary Accord Healthcare Ltd is recalling a batch of Ipratropium Bromide 500 microgram/2ml Nebuliser Solution distributed in the United Kingdom because some ampoules in the packaging have incorrect labels—they are labeled in Korean and marked with different batch information than intended for UK use. The ampoules contain the correct medicine and active ingredient, but the labeling discrepancy means patients cannot verify batch details or understand the label instructions.

Recalling firm

Accord Healthcare Ltd

Reason

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.

Classification

Class II

Category

drug recall

Country

United Kingdom

Agency

UK Medicines and Healthcare products Regulatory Agency

Recall date

2025-10-23

Status

Ongoing

Distribution

United Kingdom

Official recall notice from UK Medicines and Healthcare products Regulatory Agency

Recall details on Nibble Recalls: https://trynibble.app/recalls/8574e606-22a7-4f2b-ae58-7bc6208164a7