Class 2 Medicines recall: Actavis Group PTC EHF - Irbesartan 300mg Film-coated tablets, PL 30306/0108 and Irbesartan / Hydrochlorothiazide 300 / 25mg Film-coated Tablets, PL 30306/0267 (MDR 94-06/18)

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

From:
Medicines and Healthcare products Regulatory Agency
Published
13 February 2019
Message type:
Medicines recall/notification
Medical specialty:
Anaesthetics, Cardiology, Care home staff, Cosmetic surgery, Critical care, Dentistry, General practice, General surgery, Haematology and oncology, Infection prevention, Obstetrics and gynaecology, Ophthalmology, Orthopaedics, Paediatrics, Pathology, Pharmacy, Physiotherapy and occupational therapy, Radiology, Renal medicine, Theatre practitioners, Urology, Vascular and cardiac surgery
Issued:
13 February 2014

Actavis Pharma UK Limited

Irbesartan 300mg Film-coated tablets, PL 30306/0108

Batch number Expiry date Pack size First distributed
191018 05/2020 1 x 28 30 Nov 2018
191118 05/2020 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.

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. NHS regional teams are asked to forward this to relevant clinics, general practitioners and community pharmacists.

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Class 2 Medicines recall: Actavis Group PTC EHF

Published 13 February 2019
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