Class 2 Medicines Recall: Actavis Group PTC EHF - recall of batches of Irbesartan/Hydrochlorothiazide 300/12.5mg Film-coated Tablets and Irbesartan/Hydrochlorothiazide 150/12.5mg Film-coated Tablets

Actavis Group PTC EHF is recalling the below batches from pharmacies as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA).

Actavis Group PTC EHF

Irbesartan/Hydrochlorothiazide 300/12.5mg Film-coated Tablets, PL 30306/0266

Batch number Expiry date Pack size Date of first distribution
059118 31/03/2020 1 x 28 17/09/2018
099218 31/03/2020 1 x 28 04/10/2018
191418 31/05/2020 1 x 28 25/10/2018

Irbesartan / Hydrochlorothiazide 150/12.5mg Film-coated Tablets, PL 30306/0265

  • Batch number: 150118
  • Expiry date: 30/04/2020
  • Pack size: 1 x 28
  • Date of first distribution: 12/09/2018

Healthcare Professionals and wholesalers

  • Stop supplying the above 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.

This is a developing issue and the MHRA is actively involved with the European Medicines Agency and with other medicines regulators to determine any possible impact. An investigation into other potentially impacted products is continuing and further updates will be provided as the investigation progresses.

Company contacts for further information

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. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists.

Download document Class 2 Medicines recall: Irbesartan/Hydrochlorothiazide 300 / 12.5mg Film-coated Tablets

Published 3 January 2019