21 December 2018: Precautionary Pharmacy Level Recall of Two Batches of Irprezide (Irbesartan / Hydrochlorothiazide) Tablets by Teva

Pharmacists are advised that, as part of the ongoing EU-wide review of the sartan impurity issue, Teva is recalling two batches of lrprezide (lrbesartan/Hydrochlorothiazide) 150mg/12.5mg and 300mg/12.5mg tablets to pharmacy level.

To assist pharmacists with this recall, the HPRA issued an Advance Notice yesterday afternoon via the PSI. A copy of the recall letter which is being sent by Teva to pharmacists is also available below for information:

Teva lrprezide - Pharmacy Recall Letter - 21 December 2018
 
A copy of the recall letter which is being sent by Teva to medicines wholesalers is also provided below for information:

Teva lrprezide - Recall Letter for Wholesalers - 21 December 2018
 

Background Information

In September 2018, it was announced that the EU-wide review of the valsartan impurity issue would be expanded to include medicines containing four other 'sartans', namely candesartan, irbesartan, losartan and olmesartan. This review had commenced when trace levels of N-nitrosodimethylamine (NDMA) were found in some valsartan medicines, which have now been recalled across Europe.

Like valsartan, these additional active substances have a specific chemical ring structure (tetrazole) whose synthesis could potentially lead to the formation of impurities such as NDMA and NDEA (N-nitrosodiethylamine). Other medicines of the class which do not have this ring are not included in the review.

Both NDEA and NDMA are classified as probable human carcinogens (substances that could cause cancer). However, to date and as part of the ongoing review of this issue, only very low levels of these impurities have been detected during product testing and there is no evidence that the presence of these impurities has caused any harm to patients.  

As the EU-wide review continues it is anticipated that further precautionary recalls may be necessary to prevent any further exposure to these impurities in the affected medicines whilst the investigation is ongoing.