Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products, EL (21)A/19

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

Company name

Aventis Pharma Limited T/A Sanofi

Aprovel 75mg Film-Coated Tablets, EU/1/97/046/017

Batch number Expiry date Pack size First distributed
9A111 July 2022 28 11 Dec 2019
9A118 Oct 2022 28 27 March 2020

Aprovel 150mg Film-Coated Tablets, EU/1/97/046/022, (PLGB 04425/0788)

Batch number Expiry date Pack size First distributed
0R258 Jan 2023 28 18 Jun 2020
0R855** Sep 2023** 28 04 Nov 2020
8R827 Oct 2021 28 16 Jun 2019
9R217 Dec 2021 28 18 Sep 2019
9R2N7 Aug 2022 28 05 Nov 2019
9R40E Aug 2022 28 27 Jan 2020

** Following correction by the Aventis Pharma Limited T/A Sanofi, an update was made on 16 August 2021 to reflect correction of a batch specific expiry date. Initial recall notice: Batch Number 0R855 Exp date: Sep 2023 Revised recall notice: Batch Number 0R855 Exp date: Apr 2023

Aprovel 300mg Film-Coated Tablets, EU/1/97/046/027, (PLGB 04425/0789)

Batch number Expiry date Pack size First distributed
0R262 Jan 2023 28 08 Oct 2020
0R263 Jan 2023 28 30 Sep 2020
8R830 Oct 2021 28 09 Aug 2019
9R27A Jun 2022 28 10 Dec 2019
9R2N9 Aug 2022 28 08 Apr 2020

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

Batch number Expiry date Pack size First distributed
0R824 Apr 2023 28 18 Aug 2020

Co-Aprovel 300mg/12.5mg Film-Coated Tablets, EU/1/98/086/017, (PLGB 04425/0792)

Batch number Expiry date Pack size First distributed
0R16E May 2023 28 19 Jan 2021
0R2EL Aug 2023 28 15 Mar 2021
8R962 Oct 2021 28 27 Dec 2018

Zentiva

Irbesartan Zentiva 75mg Film-Coated Tablets, EU/1/06/376/017

Batch number Expiry date Pack size First distributed
9A111 Jul 2022 28 14 Oct 2019

Parallel Distributors

Doncaster Pharmaceuticals Group Ltd

Aprovel 150mg Film-Coated Tablets, EU/1/97/046/004

Manufacturer’s Batch Number Parallel Distributor’s Batch number Expiry date Pack size First distributed
FT050 FT050/3218 Mar 2023 28 10 Nov 2020

MPT Pharma Limited

Aprovel 75mg Film-Coated Tablets, EU/1/97/046/017

Manufacturer’s Batch Number Parallel Distributor’s Batch number Expiry date Pack size First distributed
9A111 CONS 160248 Jul 2022 28 02 Mar 2020
9A118 CONS 162175 Oct 2022 28 01 Sep 2020

PCO Manufacturing Ltd

Co-Aprovel 300mg/12.5mg Film-Coated Tablets, EU/1/98/086/017

Manufacturer’s Batch Number Parallel Distributor’s Batch number Expiry date Pack size First distributed
FT013 FT013:: RN248 Feb 2023 28 25 Jan 2021

Gowrie Laxmico Ltd T/A B&S Healthcare

Aprovel 150mg Film-Coated Tablets, EU/1/97/046/004, (PLGB 18799/3988)

Manufacturer’s Batch Number Parallel Distributor’s Batch number (Int No.) Expiry date Pack size First distributed
FT050 10R0284 Mar 2023 28 22 Oct 2020
FT050 05T0767 Mar 2023 28 18 Jun 2021

Co-Aprovel 150mg/12.5mg Film-Coated Tablets, EU/1/98/086/001, (PLGB 18799/3984)

Manufacturer’s Batch Number Parallel Distributor’s Batch number (Int No.) Expiry date Pack size First distributed
FT037 08R0074 Feb 2023 28 23 Oct 2020

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 whilst the investigation is ongoing.

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 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

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.

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, Irbesartan-containing products, EL (21)A/19

Updates to this page

Published 9 August 2021