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CLASS 2 RECALL - VARIOUS SUPPLIER & PRODUCTS

Recalls and Alerts

Class 2 Recall

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

 

Pip code

Product description

Supplier

Batch Numbers

ALLIANCE DO NOT STOCK

APROVEL FILM COATED TABS 75MG

SANOFI

9A111

9A118

ALLIANCE DO NOT STOCK

APROVEL FC TAB 150MG

SANOFI

0R258

0R855

8R827

9R217

9R2N7

9R40E

ALLIANCE DO NOT STOCK

APROVEL TAB 300MG

SANOFI

0R262

0R263

8R830

9R27A

9R2N9

ALLIANCE DO NOT STOCK

CO-APROVEL FC 150MG/12.5MG

SANOFI

0R824

ALLIANCE DO NOT STOCK

CO-APROVEL FC 300MG/12.5MG

SANOFI

0R16E

0R2EL

8R962

 

Zentiva

 

Pip code

Product description

Livery

Batch Numbers

Alliance do not stock

IRBESARTAN 75MG TABLETS

ZENTIVA

9A111

Parallel Distributors

Doncaster Pharmaceuticals Group Ltd

Pip code

Product description

Livery

Batch Numbers

8449241               

PI APROVEL TAB 150MG

Doncaster Pharmaceuticals

FT050/3218

 

 

MPT Pharma Limited

 

Pip code

Product description

Livery

Batch Numbers

7108889

PI APROVEL FC TAB 75MG

MPT Pharma Limited

CONS160248

CONS162175

 

PCO Manufacturing Ltd

 

Pip code

Product description

Livery

Batch Numbers

ALLIANCE DO NOT STOCK

PI CO-APROVEL FC 300MG/12.5MG

PCO Manufacturing Ltd

FT013::RN248

 

Gowrie Laxmico Ltd T/A B&S Healthcare

 

Pip code

Product description

Livery

Batch Numbers

ALLIANCE DO NOT STOCK

PI APROVEL TAB 150MG

Gowrie Laxmico Ltd T/A B&S Healthcare

10R0284

05T0767

ALLIANCE DO NOT STOCK

PI CO-APROVEL 150MG/12.5MG TABS

Gowrie Laxmico Ltd T/A B&S Healthcare

08R0074

 

 

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.