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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