Valsartan Precautionary Recall
Please note this page contains detailed information on the recall of specific valsartan products from the Irish market which was initiated on 5 July 2018. Please see our news page for the latest information including details of the EMA's review which is focused on assessing the potential impact for patients that may have used medicines containing NDMA.
- Parallel Imported Products
The HPRA is today proceeding with the precautionary recall of certain parallel imported Valsartan products. This is a targeted recall. Only those pharmacies that received stock of the products in question from the parallel importer companies – Eurodrug/Imbat, IMED Healthcare and PCO – are directly impacted by this recall action. As a result, the volume of packs that will be recalled on this occasion is significantly lower than in the earlier recall of 5 July 2018.
The vast majority of patients taking valsartan-containing medicines will not be impacted by this extended recall and patients are not being asked to take any action at this point. Those patients who may have been in receipt of the products in question will be contacted directly by their pharmacist who will advise them on any actions required.
The three companies listed above will today e-mail recall letters directly to the impacted pharmacies and this will be followed-up with printed copies sent by post.
To assist pharmacists with this phase of the recall, the HPRA issued an Advance Notice yesterday afternoon via the PSI and this was also shared with IPU members. This notice provides detailed information and next steps for those pharmacies who may have been in receipt of these parallel imported products.
Copies of the three recall letters are also available for information below:
Eurodrug/Imbat Valsartan PPA Recall Letter - 11 July 2018
IMED Healthcare Valsartan PPA Recall Letter - 11 July 2018
PCO Valsartan PPA Recall Letter - 11 July 2018
For ease of reference, the HPRA has now also published a complete list / table of all valsartan-containing medicines impacted by this recall for download and print. This includes:
(1) the list of the parallel imported products affected across all three companies;
(2) the initial list of Valsartan-containing products affected (published 5 July 2018)
Additional stocks of unaffected valsartan-containing medicines became available for wholesalers yesterday, Friday 6 July. Further supplies to that mentioned yesterday will also be available on Monday morning 9 July for ordering by pharmacies. While the stock situation will remain constrained there should be adequate supplies next week to meet immediate patient needs.
The HPRA wishes to advise that the supply of unaffected valsartan-containing medicines is becoming constrained at this time and that it is working with manufacturers and wholesalers in relation to the issue. New stocks of unaffected valsartan-containing medicines are expected to be available in Ireland next week, but the supply situation is likely to remain constrained for a period of time.
The Medicines Management Programme have issued guidance on their webpage for prescribers who may need to consider alternative medicines to valsartan if supplies of valsartan are not available. Please see Angiotensin II receptor blockers (ARBs) - Guidance for Prescribers.
This is an evolving situation and it is recommended to monitor the HPRA website in the coming days for any updates. We also recommend registering on the HPRA website for any alerts.
Update 05/07/2018 The HPRA alongside the European regulatory network are undertaking a precautionary recall of a number of specific medicines containing the active ingredient valsartan that are used to treat blood pressure and heart conditions. See list of affected medicines below.
This recall is underway following recent and emerging information that an impurity has been identified as part of the manufacturing process in a valsartan active substance manufactured at one facility based in China. At present there is no evidence that this impurity has caused any harm to patients. However this recall action is being undertaken as a precautionary measure to prevent any further exposure to the impurity in the affected medicines while the investigation is ongoing.
Work is currently ongoing on a European level to better understand the potential impact of this impurity. As this is an emerging issue the HPRA will provide further updates as the information becomes available.
Current information for patients and healthcare professionals is available below.
Advice to Patients:
- Patients should not stop taking their treatment abruptly. The health risk of abruptly discontinuing the medicine is higher than any potential risk presented by the impurity.
- Patients who are taking valsartan-containing medicines should, if possible, access the HPRA website at www.hpra.ie, where a list of the affected medicines is given.
- Patients should contact their pharmacist at an early opportunity for further advice in the first instance.