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

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

February 13, 2019

Drug alert number: EL (19) A/04

Date issued: 13th February 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 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 Expiry Date Pack Size First Distributed
  263918   06/2020   1 x 28   21 Nov 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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