Class 2 Medicines Recall: Bristol Labs Ltd, Brown & Burk UK Ltd, Teva UK Ltd, Irbesartan -containing and Losartan-containing products, EL (21)A/14
Bristol Laboratories Limited, Brown & Burk UK Ltd and Teva UK Ltd are recalling the above batches of products due to presence of a mutagenic impurity
MDR Number: MDR 050-10/20
Company name: Bristol Laboratories Limited, Brown and Burk Ltd and Teva UK Ltd
Product description and details of the affected batches
Bristol Laboratories Limited –
- Irbesartan 75mg Tablets PL 17907/0421
|
Batch no. |
Expiry Date |
Pack Size |
First Distributed |
|
POM0007 |
February 2023 |
28 |
08/12/2020 |
|
POM0008 |
February 2023 |
28 |
13/01/2021 |
|
POM0009 |
February 2023 |
28 |
18/02/2021 |
|
POM0010 |
February 2023 |
28 |
20/04/2021 |
- Irbesartan 150mg Tablets PL 17907/0422
|
Batch no. |
Expiry Date |
Pack Size |
First Distributed |
|
PON0005 |
January 2023 |
28 |
15/02/2021 |
|
PON0006 |
January 2023 |
28 |
08/03/2021 |
|
PON0007 |
January 2023 |
28 |
29/03/2021 |
|
PON0008 |
January 2023 |
28 |
12/04/2021 |
|
PON0009 |
January 2023 |
28 |
20/04/2021 |
- Irbesartan 300mg Tablets PL 17907/0423
|
Batch no. |
Expiry Date |
Pack Size |
First Distributed |
|
POO0005 |
February 2023 |
28 |
30/11/2020 |
Active Pharmaceuticak Ingredient: irbesartan
Brown and Burk UK Ltd -
- Irbesartan 75mg Tablets PL 25298/0073
|
Batch no. |
Expiry Date |
Pack Size |
First Distributed |
|
IAAG017 |
May 2022 |
28 |
15/11/2019 |
|
IAAG018 |
May 2022 |
28 |
14/10/2019 |
|
IAAG019 |
May 2022 |
28 |
13/02/2020 |
|
IAAG022 |
Aug 2022 |
28 |
19/03/2020 |
|
IAAG023 |
Aug 2022 |
28 |
17/11/2020 |
- Irbesartan 150mg Tablets PL 25298/0074
|
Batch no. |
Expiry Date |
Pack Size |
First Distributed |
|
IABG033 |
May 2022 |
28 |
09/09/2019 |
|
IABG034 |
May 2022 |
28 |
16/09/2019 |
|
IABG035 |
May 2022 |
28 |
22/10/2019 |
|
IABG037 |
July 2022 |
28 |
05/12/2019 |
|
IABG038 |
July 2022 |
28 |
17/02/2020 |
|
IABG039 |
July 2022 |
28 |
13/02/2020 |
|
IABG051 |
Jan 2023 |
28 |
27/05/2020 |
- Irbesartan 300mg Tablets PL 25298/0075
|
Batch no. |
Expiry Date |
Pack Size |
First Distributed |
|
IACG027 |
Jun 2022 |
28 |
22/11/2019 |
|
IACG028 |
Jun 2022 |
28 |
17/12/2019 |
|
IACG032 |
Jun 2022 |
28 |
27/02/2020 |
|
IACG035 |
Sep 2022 |
28 |
09/03/2020 |
|
IACG036 |
Sep 2022 |
28 |
15/04/2020 |
|
IACG037 |
Sep 2022 |
28 |
19/05/2020 |
- Irbesartan/Hydrochlorthiazide 150mg/12.5mg Tablets PL 25298/0070
|
Batch no. |
Expiry Date |
Pack Size |
First Distributed |
|
IZAG020 |
May 2023 |
28 |
10/11/2020 |
- Irbesartan/Hydrochlorthiazide 300mg/12.5mg Tablets PL 25298/0071
|
Batch no. |
Expiry Date |
Pack Size |
First Distributed |
|
IZCG010 |
Aug 2022 |
28 |
23/12/2019 |
- Irbesartan/Hydrochlorthiazide 300mg/25mg Tablets PL 25298/0072
|
Batch no. |
Expiry Date |
Pack Size |
First Distributed |
|
IZBG008 |
Jul 2022 |
28 |
14/05/2020 |
Teva UK Ltd –
- Losartan Potassium 50mg Tablets PL 00289/0964
|
Batch no. |
Expiry Date |
Pack Size |
First Distributed |
|
108885 |
May 2023 |
28 |
04/11/2020 |
- Losartan Potassium 100mg Tablets PL 00289/0965
|
Batch no. |
Expiry Date |
Pack Size |
First Distributed |
|
106077 |
Oct 2022 |
28 |
18/05/2020 |
|
|
|
|
|
|
|
|
|
|
Brief description of 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 to 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.
Company contacts 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