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Actavis Group irbesartan/hydrochlorothiazide recall

Contamination risk with probable carcinogen

January 4th 2019

Tagged: MHRA alert

By Ailsa Colquhoun

Actavis Group is recalling the following batches of 12.5mg film-coated irbesartan/
hydrochlorothiazide tablets as a precautionary measure due to possible contamination with N‑nitrosodiethylamine (NDEA), which has been linked with cancer.

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

Healthcare professionals are asked to:

  • 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.
  • If there are local supply issues, 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.

In case of queries, contact:

  • For Actavis (now Accord) stock control: customer services team on 0800 373573.
  • For medical information enquires: Accord medical information on 01271 385257.

 

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