MHRA Class 2 Medicines Recall: Irbesartan and Losartan containing products

MHRA Class 2 Medicines Recall: Irbesartan and Losartan containing products

June 17, 2021

MHRA Class 2 Medicines Recall: Bristol Laboratories Limited, Brown & Burk UK Ltd, Teva UK Ltd, Irbesartan-containing and Losartan-containing products

Drug alert number: EL (21)A/14

MDR Number: MDR 015-05/21

Date issued: 17th June 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 medicines recall for Bristol Laboratories Limited, Brown & Burk UK Ltd, Teva UK Ltd, Irbesartan-containing and Losartan-containing products

Brief description of the problem

Bristol Laboratories Limited, Brown & Burk UK Ltd and Teva UK Ltd are recalling the below batches of products as a precautionary measure due to contamination with an impurity called 5-(4’-(azidomethyl)- [1,1’-biphenyl]-2yl)-1H-tetrazole, which has mutagenic potential. These batches are being recalled as the level of contamination is above the acceptable limit.

Bristol Laboratories Limited

Irbesartan 75mg film coated tablets PL 17907/0421

Batch Number Expiry Date Pack Size First Distributed
POM0007 February 2023 28 8 Dec 2020
POM0008 February 2023 28 13 Jan 2021
POM0009 February 2023 28 18 Feb 2021
POM0010 February 2023 28 20 Apr 2021

Irbesartan 150mg film coated tablets PL 17907/0422

Batch Number Expiry Date Pack Size First Distributed
PON0005 January 2023 28 15 Feb 2021
PON0006 January 2023 28 8 Mar 2021
PON0007 January 2023 28 29 Mar 2021
PON0008 January 2023 28 12 Apr 2021
PON0009 January 2023 28 20 Apr 2021

Irbesartan 300mg film coated tablets PL 17907/0423

Batch Number Expiry Date Pack Size First Distributed
POO0005 February 2023 28 30 Nov 2020

Brown and Burk UK Ltd

Irbesartan 75mg film coated tablets PL 25298/0073

Batch Number Expiry Date Pack Size First Distributed
IAAG017 May 2022 28 15 Nov 2019
IAAG018 May 2022 28 14 Oct 2019
IAAG019 May 2022 28 13 Feb 2020
IAAG022 Aug 2022 28 19 Mar 2020
IAAG023 Aug 2022 28 17 Nov 2020

Irbesartan 150mg film coated tablets PL 25298/0074

Batch Number Expiry Date Pack Size First Distributed
IABG033 May 2022 28 09 Sep 2019
IABG034 May 2022 28 16 Sep 2019
IABG035 May 2022 28 22 Oct 2019
IABG037 Jul 2022 28 05 Dec 2019
IABG038 Jul 2022 28 17 Feb 2020
IABG039 Jul 2022 28 13 Feb 2020
IABG051 Jan 2023 28 27 May 2020

Irbesartan 300mg film coated tablets PL 25298/0075

Batch Number Expiry Date Pack Size First Distributed
IACG027 Jun 2022 28 22 Nov 2019
IACG028 Jun 2022 28 17 Dec 2019
IACG032 Jun 2022 28 27 Feb 2020
IACG035 Sep 2022 28 09 Mar 2020
IACG036 Sep 2022 28 15 Apr 2020
IACG037 Sep 2022 28 19 May 2020

Irbesartan/Hydrochlorothiazide 150mg/12.5mg Film Coated Tablets PL 25298/0070

Batch Number Expiry Date Pack Size First Distributed
IZAG010 May 2023 28 10 Nov 2020

Irbesartan/Hydrochlorothiazide 300mg/12.5mg Film Coated Tablets PL 25298/0071

Batch Number Expiry Date Pack Size First Distributed
IZCG020 Aug 2022 28 23 Dec 2019

Irbesartan/Hydrochlorothiazide 300mg/25mg Film Coated Tablets PL25298/0072

Batch Number Expiry Date Pack Size First Distributed
IZBG008 Jul 2022 28 14 May 2020

Teva UK Ltd

Losartan Potassium 50mg Film Coated Tablets PL 00289/0964

Batch Number Expiry Date Pack Size First Distributed
108885 May 2023 28 04 Nov 2020

Losartan Potassium 100mg Film Coated Tablets PL 00289/0965

Batch Number Expiry Date Pack Size First Distributed
106077 October 2022 28 18 Mar 2020

Advice for healthcare professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Patients are advised not to stop taking their medication prior to consultation with their doctor or pharmacist, as the health risk of discontinuing the medicine is higher than the potential risk presented by the impurity. This recall is being undertaken as a precautionary measure to prevent further exposure to this impurity in the affected medicines whilst the investigation is ongoing.

There are no anticipated shortages of irbesartan-containing and losartan-containing products in the UK as a result of this recall. However, this is a developing issue and MHRA is working with Marketing Authorisation Holders and 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.

Full drug safety notice can be viewed here.

Contact details for further information:


Bristol Laboratories Limited

For more information or medical information queries please contact notifications@bristol-labs.co.uk
For supply queries, please contact notifications@bristol-labs.co.uk

Brown & Burk UK Ltd

For more information or medical information queries please contact pv@bbukltd.com
For supply queries, please contact customercare@bbukltd.com or 0203 384 7188

Teva UK Limited

For more information or medical information queries please contact Teva Medical Information at medinfo@tevauk.com or 0207 540 7117
For supply queries, please contact Teva Customer Solutions at customer.services@tevauk.com or 0800 590502

 



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