Class 2 MHRA Medicines Recall: Irbesartan / Hydrochlorothiazide (Actavis Group PTC EHF)

Class 2 MHRA Medicines Recall: Irbesartan / Hydrochlorothiazide (Actavis Group PTC EHF)

January 3, 2019

Drug alert number: EL (19) A/01

Date issued: 3rd January 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 pharmacy level medicines recall, to be actioned within 48 hours, for certain batches of  Irbesartan / Hydrochlorothiazide containing products. Actavis Group PTC EHF is recalling the batches identified below from pharmacies as a precautionary measure due to possible contamination with N-nitrosodiethylamine (NDEA).

Irbesartan / Hydrochlorothiazide 300 / 12.5mg film coated tablets, PL 30306/0266

Batch Number Expiry Date Pack Size First Distributed
  059118   31/03/2020   28   17/09/2018
  099218   31/03/2020   28   04/10/2018
  191418   31/05/2020   28   25/10/2018

Irbesartan / Hydrochlorothiazide 150 / 12.5mg film coated tablets, PL 30306/0265

Batch Number Expiry Date Pack Size First Distributed
  150118   30/04/2020   28   12/09/2018

Community pharmacy teams should stop supplying the above products/batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

To view the alert please visit the GOV.UK website.

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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