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CLASS 2 RECALL - IRBESARTAN-CONTAINING AND LOSARTAN-CONTAINING PRODUCTS

Recalls and Alerts

Class 2 Recall

CLASS 2 RECALL - IRBESARTAN-CONTAINING AND LOSARTAN-CONTAINING PRODUCTS

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

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-bristol-laboratories-limited-brown-and-burk-uk-ltd-teva-uk-ltd-irbesartan-containing-and-losartan-containing-products-el-21-a-slash-14?utm_medium=email&utm_campaign=govuk-notifications&utm_source=6bdefacf-875e-4062-aa0b-ebeba6a9dc5d&utm_content=immediately   

Bristol Laboratories Limited

 

Pip code

Product description

Livery

Batch Numbers

1149657

Irbesartan 75 mg Film Coated Tablets

Bristol Laboratories Limited

POM0007

POM0008

POM0009

POM0010

6359616

Irbesartan 75 mg Film Coated Tablets

Bristol Laboratories Limited

POM0007

POM0008

POM0009

POM0010

1149715

Irbesartan 150 mg Film Coated Tablets

Bristol Laboratories Limited

PON0005

PON0006

PON0007

PON0008

PON0009

6359624

Irbesartan 150 mg Film Coated Tablets

Bristol Laboratories Limited

PON0005

PON0006

PON0007

PON0008

PON0009

1176536

Irbesartan 150 mg Film Coated Tablets

Bristol Laboratories Limited

PON0005

PON0006

PON0007

PON0008

PON0009

1149665

Irbesartan 300 mg Film Coated Tablets

Bristol Laboratories Limited

POO0005

6359608

Irbesartan 300 mg Film Coated Tablets

Bristol Laboratories Limited

POO0005

1176544

Irbesartan 300 mg Film Coated Tablets

Bristol Laboratories Limited

POO0005

Brown and Burk UK Limited

 

Pip code

Product description

Livery

Batch Numbers

1149657

Irbesartan 75 mg Film Coated Tablets

Brown and Burk UK Limited

IAAG017

IAAG018

IAAG019

IAAG022

IAAG023

6359616

Irbesartan 75 mg Film Coated Tablets

Brown and Burk UK Limited

IAAG017

IAAG018

IAAG019

IAAG022

IAAG023

1149715

Irbesartan 150 mg Film Coated Tablets

Brown and Burk UK Limited

IABG033

IABG034

IABG035

IABG037

IABG038

IABG039

IABG051

6359624

Irbesartan 150 mg Film Coated Tablets

Brown and Burk UK Limited

IABG033

IABG034

IABG035

IABG037

IABG038

IABG039

IABG051

1176536

Irbesartan 150 mg Film Coated Tablets

Brown and Burk UK Limited

IABG033

IABG034

IABG035

IABG037

IABG038

IABG039

IABG051

1149665

Irbesartan 300 mg Film Coated Tablets

Brown and Burk UK Limited

IACG027

IACG028

IACG032

IACG035

IACG036

IACG037

6359608

Irbesartan 300 mg Film Coated Tablets

Brown and Burk UK Limited

IACG027

IACG028

IACG032

IACG035

IACG036

IACG037

1176544

Irbesartan 300 mg Film Coated Tablets

Brown and Burk UK Limited

IACG027

IACG028

IACG032

IACG035

IACG036

IACG037

1186840

Irbesartan/Hydrochlorothiazide 150mg/12.5mg Film Coated Tablets,

Brown and Burk UK Limited

IZAG020

8382673

Irbesartan/Hydrochlorothiazide 150mg/12.5mg Film Coated Tablets,

Brown and Burk UK Limited

IZAG020

1186857

Irbesartan/Hydrochlorothiazide 300mg/12.5mg Film Coated Tablets,

Brown and Burk UK Limited

IZCG010

8382681

Irbesartan/Hydrochlorothiazide 300mg/12.5mg Film Coated Tablets,

Brown and Burk UK Limited

IZCG010

1186832

Irbesartan/Hydrochlorothiazide 300mg/25mg Film Coated Tablets

Brown and Burk UK Limited

IZBG008

8382665

Irbesartan/Hydrochlorothiazide 300mg/25mg Film Coated Tablets

Brown and Burk UK Limited

IZBG008

Teva UK Limited

 

Pip code

Product description

Livery

Batch Numbers

1178870

Losartan potassium 50mg Film Coated Tablets

Teva UK Ltd

108885

8023574

Losartan potassium 50mg Film Coated Tablets

Teva UK Ltd

108885

1207570

Losartan potassium 50mg Film Coated Tablets

Teva UK Ltd

108885

1153626

Losartan potassium 50mg Film Coated Tablets

Teva UK Ltd

108885

1150150

Losartan potassium 50mg Film Coated Tablets

Teva UK Ltd

108885

1205707

Losartan potassium 50mg Film Coated Tablets

Teva UK Ltd

108885

8113706

Losartan potassium 50mg Film Coated Tablets

Teva UK Ltd

108885

1178888

Losartan potassium 100mg Film Coated Tablets

Teva UK Ltd

106077

8023566

Losartan potassium 100mg Film Coated Tablets

Teva UK Ltd

106077

1207588

Losartan potassium 100mg Film Coated Tablets

Teva UK Ltd

106077

1153618

Losartan potassium 100mg Film Coated Tablets

Teva UK Ltd

106077

1150168

Losartan potassium 100mg Film Coated Tablets

Teva UK Ltd

106077

 

 

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

 

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

 

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

 

If you have any questions, then please contact your local Service Centre Customer Services team.