Class 2

Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products, EL(21)A/34

Block 1

Specific batches of products supplied by Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity.

MDR Number: MDR 050-10/20

Company name: Aventis Pharma Limited T/A Sanofi

Co-Aprovel 150mg/12.5mg Film-Coated Tablets, EU/1/98/086/012, (PLGB 04425/0791)

Batch Number

Expiry Date

Pack Size

First Distributed

9R1PC

May 2022

28

Jan 2020

Co-Aprovel 300 mg/12.5 mg Film-Coated Tablets, EU/1/98/006/017, (PLGB 04425/0792)

Batch Number

Expiry Date

Pack Size

First Distributed

9R1P9

May 2022

28

Sep 2019

Company name: Chemilines Ltd

Aprovel 150mg Tablets, EU/1/97/046/004

Manufacturer’s Batch Number

Parallel Distributor’s Batch number

Expiry Date

Pack Size

First Distributed

FT022

FT022/001

Jan 2023

28

Aug 2020

FT022

FT022/002

Jan 2023

28

Oct 2020

FT022

FT022/003

Jan 2023

28

Feb 2021

Aprovel 300mg Tablets, EU/1/97/046/007

Manufacturer’s Batch Number

Parallel Distributor’s Batch number

Expiry Date

Pack Size

First Distributed

FT020

FT020/001

Jan 2023

28

July 2020

Co-Aprovel 150mg/12.5mg Tablets, EU/1/98/086/001

Manufacturer’s Batch Number

Parallel Distributor’s Batch number

Expiry Date

Pack Size

First Distributed

FT020

FT020/001

Feb 2023

28

Aug 2020

Co-Aprovel 300mg/12.5mg Tablets, EU/1/98/086/004

Manufacturer’s Batch Number

Parallel Distributor’s Batch number

Expiry Date

Pack Size

First Distributed

FT037

FT037/001

June 2023

28

Dec 2020

Company name: Drugsrus Ltd (Repackaged by P.I.E Pharma Ltd)

Co-Aprovel 150mg/12.5mg Tablets, EU/1/98/086/001

Manufacturer’s Batch Number

Parallel Distributor’s Batch number

Expiry Date

Pack Size

First Distributed

FT020

K/066

Feb 23

28

Oct 2020

Company name: Lexon (UK) Ltd

Aprovel 300mg Tablets, EU/1/97/046/007

Manufacturer’s Batch Number

Parallel Distributor’s Batch number

Expiry Date

Pack Size

First Distributed

FT027

FT027

Jan 23

28

Jul 2020

Company name: BR Lewis Pharmaceuticals Ltd (Repackaged by Doncaster Pharmaceuticals Group Ltd)

Aprovel 150mg Tablets, EU/1/97/046/004

Manufacturer’s Batch Number

Parallel Distributor’s Batch number

Expiry Date

Pack Size

First Distributed

ET042

ET042/2156

Mar 2022

28

Oct 2019

FT022

FT022/2994

Jan 2023

28

Aug 2020

FT022

FT022/3112

Jan 2023

28

Oct 2020

FT040

FT040/3218

Mar 2023

28

Nov 2020

FT052

FT052/3228

Mar 2023

28

Nov 2020

Aprovel 300mg Tablets, EU/1/97/046/007

Manufacturer’s Batch Number

Parallel Distributor’s Batch number

Expiry Date

Pack Size

First Distributed

FT027

FT027/3124

Jan 2023

28

Aug 2020

FT027

FT027/3079

Jan 2023

28

Jul 2020

Co-Aprovel 150mg/12.5mg Tablets, EU/1/98/086/012

Manufacturer’s Batch Number

Parallel Distributor’s Batch number

Expiry Date

Pack Size

First Distributed

9R1PC

9R1PC

May 2022

28

Mar 2020

Company name: Gowrie Laxmico Ltd T/A B&S Healthcare

Aprovel 150mg Tablets, EU/1/97/046/004

Manufacturer’s Batch Number

Parallel Distributor’s Batch number (Int No.)

Expiry Date

Pack Size

First Distributed

FT022

06R1441

Jan 2023

28

Jul 2020

FT022

06T0238

Jan 2023

28

Jun 2021

FT022

07R0792

Jan 2023

28

Aug 2020

FT022

11R0446

Jan 2023

28

Dec 2020

FT049

05T0766

Mar 2023

28

Jun 2021

FT050

05T0767

Mar 2023

28

Jun 2021

FT050

10R0284

Mar 2023

28

Oct 2020

Co-Aprovel 150mg/12.5mg Tablets, EU/1/98/086/001

Manufacturer’s Batch Number

Parallel Distributor’s Batch number (Int No.)

Expiry Date

Pack Size

First Distributed

FT012

06R1475

Jan 2023

28

Jul 2020

FT012

08R0102

Jan 2023

28

Sep 2020

FT020

10R0532

Feb 2023

28

Nov 2020

FT037

08R0074

Feb 2023

28

Oct 2020

Co-Aprovel 300mg/25mg Tablets, EU/1/98/086/024

Manufacturer’s Batch Number

Parallel Distributor’s Batch number (Int No.)

Expiry Date

Pack Size

First Distributed

FT029

05R1210

Jan 2023

28

Jul 2020

Company name: Quadrant Pharmaceuticals Ltd (Repackaged by Maxearn Ltd)

Aprovel 150mg Tablets, EU/1/97/046/004

Manufacturer’s Batch Number

Parallel Distributor’s Batch number (Int No.)

Expiry Date

Pack Size

First Distributed

ET065

7790R

May 2022

28

Nov 2019

ET049

1390T

May 2022

28

Mar 2020

ET049

1655T

May 2022

28

Mar 2020

ET050

1392T

May 2022

28

June 2020

ET050

1652T

May 2022

28

June 2020

FT022

9494T

Jan 2023

28

Sep 2020

FT022

9619T

Jan 2023

28

Sep 2020

FT084

1905U

Jun 2023

28

Nov 2020

ET039

4908R

Mar 2022

28

Sep 2019

 Aprovel 300mg Tablets, EU/1/97/046/007

Manufacturer’s Batch Number

Parallel Distributor’s Batch number (Int No.)

Expiry Date

Pack Size

First Distributed

FT020

9486T

Jan 2023

28

Sep 2020

Company name: OPD Laboratories Ltd

Aprovel 150mg Tablets, EU/1/97/046/004

Manufacturer’s Batch Number

Parallel Distributor’s Batch number (Int No.)

Expiry Date

Pack Size

First Distributed

FT051

FT051/1

Mar 2023

28

Sep 2020

FT051

FT051/2

Mar 2023

28

Sep 2020

FT051

FT051/3

Mar 2023

28

Nov 2020

FT052

FT052/1

Mar 2023

28

Nov 2020

Co-Aprovel 150mg/12.5mg Tablets, EU/1/98/086/001

Manufacturer’s Batch Number

Parallel Distributor’s Batch number (Int No.)

Expiry Date

Pack Size

First Distributed

FT020

FT020/1

Feb 2023

28

Mar 2021

Brief description of problem:

Specific batches of the above 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.

Advice to Healthcare Professionals:

  • Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
  • To confirm if a product has been parallel distributed and repackaged, please check the outer carton and/or affixed label for more details of the respective parallel distributor companies.

Patients are advised not to stop taking their medication prior to consultation with their doctor or pharmacist, as the health risk of discontinuing the medicine is higher than the potential risk presented by the impurity. This recall is being undertaken as a precautionary measure to prevent further exposure to this impurity in the affected medicines.

There are no anticipated shortages of irbesartan-containing products in the UK as a result of this recall. However, this is a developing issue and MHRA is working with Marketing Authorisation Holders and other medicines regulators to determine any possible impact. An investigation into other potentially impacted products is continuing and further updates will be provided as the investigation progresses.

Company contacts for 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.

To access the full recall: Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Aprovel/Co-Aprovel-containing products, EL (21)A/34