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CLASS 2 RECALL - VARIOUS MARKETING AUTHORISATION HOLDERS AND PARALLEL DISTRIBUTOR COMPANIES

Recalls and Alerts

Class 2 Recall

CLASS 2 RECALL - VARIOUS MARKETING AUTHORISATION HOLDERS AND PARALLEL DISTRIBUTOR COMPANIES

Important update:

 

Further to the recall below, the MHRA have sent an updated version with the below changes.

 

Change made:

Batch ET042/2156 has been added to BR Lewis Pharmaceuticals, 150mg Aprovel section (this batch number has been added in the table below).

 

Updated link:

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-34?utm_medium=email&utm_campaign=govuk-notifications&utm_source=51215d28-2f33-4366-a0f9-0eb7cd46f26b&utm_content=immediately

 


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-34?utm_medium=email&utm_campaign=govuk-notifications&utm_source=1bddc3b6-a77c-46a3-9a16-7732942ac3dc&utm_content=immediately   

 

Aventis Pharma Limited T/A Sanofi

 

Pip code

Product description

Supplier

Batch Numbers

ALLIANCE DO NOT STOCK

CO-APROVEL FC 150MG/12.5MG

SANOFI

9R1PC

ALLIANCE DO NOT STOCK

CO-APROVEL FC 300MG/12.5MG

SANOFI

9R1P9

Parallel Distributors

Chemilines Ltd

 

Pip code

Product description

Livery

Batch Numbers

8449241

PI APROVEL TAB 150MG

CHEMILINES

FT022/001

FT022/002

FT022/003

7108988

PI APROVEL TAB 300MG

CHEMILINES

FT020/001

7028699

PI CO-APROVEL FC 150MG/12.5MG

CHEMILINES

FT020/001

7028681

PI CO-APROVEL FC 300MG/12.5MG

CHEMILINES

FT037/001

Drugsrus Ltd (Repackaged by P.I.E Pharma Ltd)

Pip code

Product description

Livery

Batch Numbers

ALLIANCE DO NOT STOCK

PI CO-APROVEL FC 150MG/12.5MG

DRUGSRUS LTD (REPACKAGED BY P.I.E PHARMA LTD)

K/066

 

 

Lexon (UK) Ltd

Pip code

Product description

Livery

Batch Numbers

ALLIANCE DO NOT STOCK

PI APROVEL TAB 300MG

LEXON (UK) LTD

FT027

 

BR Lewis Pharmaceuticals Ltd (Repackaged by Doncaster Pharmaceuticals Group Ltd)

Pip code

Product description

Livery

Batch Numbers

8449241

PI APROVEL TAB 150MG

BR LEWIS PHARMACEUTICALS LTD (REPACKAGED BY DONCASTER PHARMACEUTICALS GROUP LTD)

ET042/2156

FT022/2994

FT022/3112

FT040/3218

FT052/3228

7108988

PI APROVEL TAB 300MG

BR LEWIS PHARMACEUTICALS LTD (REPACKAGED BY DONCASTER PHARMACEUTICALS GROUP LTD)

FT027/3124

FT027/3079

7028699

PI CO-APROVEL FC 150MG/12.5MG

BR LEWIS PHARMACEUTICALS LTD (REPACKAGED BY DONCASTER PHARMACEUTICALS GROUP LTD)

9R1PC

 

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

06R1441

06T0238

07R0792

11R0446

05T0766

05T0767

10R0284

ALLIANCE DO NOT STOCK

PI CO-APROVEL FC 150MG/12.5MG

GOWRIE LAXMICO LTD T/A B&S HEALTHCARE

06R1475

08R0102

10R0532

08R0074

ALLIANCE DO NOT STOCK

PI CO-APROVEL 300MG/25MG TABLETS

GOWRIE LAXMICO LTD T/A B&S HEALTHCARE

05R1210

 

 

Quadrant Pharmaceuticals Ltd (Repackaged by Maxearn Ltd)

Pip code

Product description

Livery

Batch Numbers

ALLIANCE DO NOT STOCK

PI APROVEL TAB 150MG

QUADRANT PHARMACEUTICALS LTD (REPACKAGED BY MAXEARN LTD)

7790R

1390T

1655T

1392T

1652T

9494T

9619T

1905U

4908R

ALLIANCE DO NOT STOCK

PI APROVEL TAB 300MG

QUADRANT PHARMACEUTICALS LTD (REPACKAGED BY MAXEARN LTD)

9486T

 

OPD Laboratories Ltd

Pip code

Product description

Livery

Batch Numbers

ALLIANCE DO NOT STOCK

PI APROVEL TAB 150MG

OPD LABORATORIES LTD

FT051/1

FT051/2

FT051/3

FT052/1

ALLIANCE DO NOT STOCK

PI CO-APROVEL FC 150MG/12.5MG

OPD LABORATORIES LTD

FT020/1

 

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 2525.

 

Chemilines

For more information or medical information queries, please contact Ashutosh Pradhan at Ashutosh.pradhan@chemilines.com.

 

For supply queries, please contact Nisha Brar at Nisha.brar@chemilines.com.

 

BR Lewis Pharmaceuticals Ltd / Doncaster Pharmaceuticals Group Ltd

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

 

Drugsrus Ltd

For more information or medical information / supply queries, please contact Drugsrus Limited at recall@drugsrus.co.uk or 0208 423 3800.

 

Lexon (UK) Ltd

For more information or medical information queries, please contact Yogesh Patel at yogesh.patel@lexonuk.com or 07515 765513.

 

For supply queries, please contact Heather Jordan at heather.jordan@lexonuk.com.

 

Gowrie Laxmico Ltd T/A B&S Healthcare

For more information or medical information queries, please contact medinfo@bnsheathcare.com or 0800 049 9401 ext 941.

 

For supply queries, please contact customerservice@bnshealthcare.com.

 

Quadrant Pharmaceuticals Ltd

For all enquiries please contact Radoslaw Bandomir at radoslaw.bandomir@maxearn.co.uk.

 

OPD Laboratories Ltd

For more information or medical information queries, please contact Sasi Vimalaranjithan / Hemang Patel at 01923 332 796 or sasi@sigmaplc.com / hemang@sigmaplc.com.

 

For supply queries, please contact Vasanth Samson / Krina Shah at qa@sigmaplc.com.

 

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.

 

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