CLASS 2 RECALL - VARIOUS SUPPLIER & PRODUCTS

Specific batches of the below products are recalled by the Marketing Authorisation Holders and parallel distributor companies 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-various-marketing-authorisation-holders-and-parallel-distributor-companies-irbesartan-containing-products-el-21-a-slash-19?utm_medium=email&utm_campaign=govuk-notifications&utm_source=7fde90cb-19d4-417d-888c-d7769dcf3f3f&utm_content=immediately   

Please can you ensure that your stores quarantine the product listed below.

Aventis Pharma Limited T/A Sanofi

Zentiva

Parallel Distributors

Doncaster Pharmaceuticals Group Ltd

MPT Pharma Limited

PCO Manufacturing Ltd

Gowrie Laxmico Ltd T/A B&S Healthcare

Further Information

Sanofi

For stock control enquiries, please contact GB-CustomerServices@sanofi.com or 0800 854 430

For more information or medical information queries, please contact uk-medicalinformation@sanofi.com

or 0800 035 25 25

Doncaster Pharmaceuticals Group Ltd

For more information or medical information queries, please contact Richard Gore at 01302 554805 (or

07736 297267 out of hours) or richard.gore@doncaster-pharm.com

For supply queries, please contact Rebecca Platts at 01302 552961 (Mon-Fri 8am-4pm) or

rebecca.platts@doncaster-pharm.com

MPT Pharma Limited

For more information or medical information queries, please contact qa@cstpharma.co.uk or tel 01477

549310

For supply queries, please contact: qa@cstpharma.co.uk or tel 01477 549310

EL (21)A/19 Page 4 of 4

PCO Manufacturing Ltd

For more information or medical information queries, please contact Niamh Clarke at nclarke@pco.ie

For supply queries, please contact Jason Ogle at jogle@nippharma.co.uk

Gowrie Laxmico Ltd T/A B&S Healthcare

For more information or medical information queries, please contact medinfo@bnsheathcare.com

For supply queries, please contact customerservice@bnshealthcare.com

Zentiva Pharma UK Ltd

For more information or medical information queries, please contact 0800 0902408 or

UKmedinfo@zentiva.com

For supply queries, please contact 0844 8793188 or gfd-customerservices@zentiva.com. Please contact

claims@zentiva.com to arrange return and replacement of affected packs in your possession.

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.