Class 2 MHRA Medicines Recall: Irbesartan 150mg and 300mg tablets (Macleods Pharma UK Limited)

Class 2 MHRA Medicines Recall: Irbesartan 150mg and 300mg tablets (Macleods Pharma UK Limited)

January 24, 2019

Drug alert number: EL (19) A/02

Date issued: 24th 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 containing products. Macleods Pharma UK Limited is recalling the batches identified below from pharmacies as a precautionary measure due to possible contamination with N-nitrosodiethylamine (NDEA).

Irbesartan 150mg Film-coated tablets PL 34771/0079

Batch Number Expiry Date Pack Size First Distributed
  EIZ807A   July 2021   1 x 28   21 Nov 2018

Irbesartan 300mg Film-coated tablets PL 34771/0080

Batch Number Expiry Date Pack Size First Distributed
  EIA1813A   July 2021   1 x 28   31 Oct 2018
  EIA1811A   July 2021   1 x 28   31 Oct 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 stock control enquiries and medical information enquiries, please contact eusafety@macleodspharma.com or telephone 01740 661110.



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