Specific batches of products supplied by Bristol Laboratories Limited, Brown & Burk UK Limited and Teva UK Limited are being recalled due to presence of a mutagenic impurity.

Company name

Bristol Laboratories Limited

Irbesartan 75 mg 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 150 mg 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 300 mg Film Coated Tablets, PL 17907/0423

Batch number Expiry date Pack size First distributed
POO0005 February 2023 28 30 Nov 2020

Active Pharmaceutical Ingredient: irbesartan

Brown and Burk UK Limited

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 July 2022 28 05 Dec 2019
IABG038 July 2022 28 17 Feb 2020
IABG039 July 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

Active Pharmaceutical Ingredient: irbesartan

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

Batch number Expiry date Pack size First distributed
IZAG020 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
IZCG010 Aug 2022 28 23 Dec 2019

Irbesartan/Hydrochlorothiazide 300mg/25mg Film Coated Tablets, PL 25298/0072

Batch number Expiry date Pack size First distributed
IZBG008 Jul 2022 28 14 May 2020

Active Pharmaceutical Ingredient: irbesartan, hydrochlorothiazide

Teva UK Limited

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

Active Pharmaceutical Ingredient: Losartan Potassium

Brief description of the problem

Bristol Laboratories Limited, Brown & Burk UK Ltd and Teva UK Ltd are recalling the above 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.

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.

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