The HPRA wishes to advise that, as a precautionary measure, specific batches of the products listed in Appendix I are being recalled to pharmacy level in Ireland.
The reason for this recall is due to the presence of an impurity called 5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole (termed an ‘azide’ impurity), which has mutagenic potential. At present, there is no evidence that this impurity has caused any harm to patients and therefore this pharmacy-level recall is being undertaken as a precautionary measure. Specific batches are being recalled in cases where the impurity is above regulatory acceptable levels.
Please note that this is a different impurity to that which led to previous sartan recalls in 2018 and 2019.
Recall letters are being issued by the marketing authorisation holders to wholesalers and pharmacies. Copies of the letters are available to download below and details of the batches affected are listed in Appendix 1 below. Please note that not all batches are affected. For details of replacement stock, please see individual recall letters.
Product name or type:
Specific batches of products containing irbesartan and valsartan from Sanofi-Aventis Ireland Ltd. and Clonmel Healthcare Ltd.
One batch of an irbesartan-containing product parallel distributed by PCO Manufacturing Ltd.
Please see Appendix I for more information and full product and batch details.
Pharmacists and wholesalers
Actions To Be Taken:
Information for pharmacists
Immediately quarantine any units from the batches / products listed in Appendix I. For hospital pharmacies, this will include units at wards, clinics and any other relevant locations within the hospital.
Return the quarantined units to your wholesaler. The wholesaler will be in a position to advise on receiving credit for returned packs.
As this is a pharmacy level recall, there is no requirement to contact patients. Should patients taking these medicines contact you in respect of this recall, it is important that they are advised to continue taking their medicine. This recall is being undertaken as a precautionary measure and the health risk presented by abruptly discontinuing the medicine is higher than any potential risk presented by the impurity.