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Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday (03 December) issued a class 2 pharmacy and wholesaler level recall for certain batches of Irbesartan/Hydrochlorothiazide.

Actavis Group is recalling the products from pharmacies as a precautionary measure due to possible contamination with N-nitrosodiethylamine (NDEA), a probable carcinogen.

The details of the batches being recalled:

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

Batch numberExpiry datePack sizeDate of first distribution
05911831/03/20201 x 2817/09/2018
09921831/03/20201 x 2804/10/2018
19141831/05/20201 x 2825/10/2018

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

Batch numberExpiry datePack sizeDate of first distribution
15011830/04/20201 x 2812/09/2018

MHRA has directed pharmacies and wholesalers to take action on the alert within 48 hours. It asked them to quarantine all remaining stock and return it to the supplier.

Patients should be advised not to stop taking their medication as the health risk of discontinuing the medicine is higher than the potential risk presented by the contaminant, it added.

MHRA said it is actively involved with the European Medicines Agency and other medicines regulators on this developing issue. Several affected batches of valsartan containing medicines have been recalled after finding NDEA and another impurity N-nitrosodimethylamine (NDMA). Many other sartan products are under investigation.    

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

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