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

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

From:
Medicines and Healthcare products Regulatory Agency
Published
30 November 2021
Last updated
1 December 2021 — See all updates
Message type:
Medicines recall/notification
Medical specialty:
Anaesthetics, Cardiology, Care home staff, Cosmetic surgery and Critical care
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Dentistry, Dispensing GP practices, General practice, General surgery, Haematology and oncology, Infection prevention, Obstetrics and gynaecology, Ophthalmology, Orthopaedics, Paediatrics, Pathology, Pharmacy, Physiotherapy and occupational therapy, Radiology, Renal medicine, Theatre practitioners, Urology, and Vascular and cardiac surgery
Issued:
30 November 2021

MDR Number

MDR 050-10/20

Company name

Aventis Pharma Limited T/A Sanofi

Product description

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

Parallel Distributors

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

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

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

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

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

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

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

Aprovel – active pharmaceutical ingredient: irbesartan

Co-Aprovel – active pharmaceutical ingredients: irbesartan and hydrochlorothiazide

Brief description of the 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 for 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.

Further Information

Sanofi

For stock control enquiries, please contact [email protected] or 0800 854 430.

For more information or medical information queries, please contact [email protected] or 0800 035 2525.

Chemilines

For more information or medical information queries, please contact Ashutosh Pradhan at [email protected].

For supply queries, please contact Nisha Brar at [email protected].

BR Lewis Pharmaceuticals Ltd / Doncaster Pharmaceuticals Group Ltd

For more information or medical information queries, please contact Richard Gore at 01302 554805 or [email protected].

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

Drugsrus Ltd

For more information or medical information / supply queries, please contact Drugsrus Limited at [email protected] or 0208 423 3800.

Lexon (UK) Ltd

For more information or medical information queries, please contact Yogesh Patel at [email protected] or 07515 765513.

For supply queries, please contact Heather Jordan at [email protected].

Gowrie Laxmico Ltd T/A B&S Healthcare

For more information or medical information queries, please contact [email protected] or 0800 049 9401 ext 941.

For supply queries, please contact [email protected].

Quadrant Pharmaceuticals Ltd

For all enquiries please contact Radoslaw Bandomir at [email protected].

OPD Laboratories Ltd

For more information or medical information queries, please contact Sasi Vimalaranjithan / Hemang Patel at 01923 332 796 or [email protected] / [email protected].

For supply queries, please contact Vasanth Samson / Krina Shah at [email protected].

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

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

Updates to this page

Published 30 November 2021
Last updated 1 December 2021 + show all updates

  1. Batch ET042 added to BR Lewis Pharmaceuticals, 150mg Aprovel section.

  2. First published.

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