Source: Medicines & Healthcare products & Regulatory Agency (MHRA)
On the 13th of February 2019, MHRA issued a Class 2 Medicines Recall for the Irbesartan 300mg Film-Coated Tablets; Irbesartan and the Hydrochlorothiazide 300 / 25mg Film-Coated Tablets manufactured by Actavis Group Ptc Ehf. The alert is in regards to the above batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).
All Healthcare Professionals and wholesalers
- Stop supplying the batches listed above immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
- If you receive queries about this issue from patients, advise them not to stop taking their medication as the health risk of discontinuing the medicine is higher than the potential risk presented by the contaminant. A treatment review is not necessary until the next routine appointment.
- We do not anticipate any shortages of Irbesartan containing products. It is possible, however, that there may be some local supply issues, in which case patients should be advised to speak to their doctor to discuss alternative treatments.
The MHRA continues to thoroughly investigate the issue alongside the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines (EDQM).