Actavis Pharma UK Limited
Irbesartan 300mg Film-coated tablets, PL 30306/0108
||1 x 28
||30 Nov 2018
||1 x 28
||20 Dec 2018
Irbesartan / Hydrochlorothiazide 300 / 25mg Film-coated Tablets, PL 30306/0267
- Batch number: 263918
- Expiry date: 06/2020
- Pack size: 1 x 28
- First distributed: 21 Nov 2018
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 to continue 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). We will continue to monitor the situation in the UK and consider what actions are necessary to protect public health.
For Actavis (now Accord) stock control: Customer Services Team on 0800 373573
For medical information enquires please contact Accord Medical Information on 01271 385257
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to relevant clinics, general practitioners and community pharmacists.
Published 13 February 2019