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.