MHRA Class 2 Medicines Recall: Irbesartan-containing products – Updated

MHRA Class 2 Medicines Recall: Irbesartan-containing products – Updated

August 16, 2021

Updated: 16/08/21 – the expiry date  for Aprovel 150mg tablets batch 0R855 should be April 2023 


MHRA Class 2 Medicines Recall: Irbesartan-containing products

Drug alert number: EL (21)A/19

MDR Number: MDR 050-10/20

Date issued: 5th August 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Class 2 medicines recall for Irbesartan-containing products:

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.

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 Mar 2020

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

Batch Number Expiry Date Pack Size First Distributed
0R258 Jan 2023 28 18 Jun 2020
0R855 Apr 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

Aprovel 300mg Film-Coated Tablets EU/1/97/046/027 (PL GB 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 (PL GB 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 (PL GB 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 k.s

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 300 mg/12.5 mg 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 (PL GB 18799/3988)

Manufacturer’s Batch Number Parallel Distributor’s Batch Number 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 Expiry Date Pack Size First Distributed
FT037 08R0074 Feb 2023 28 23 Oct 2020

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.

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.

Full drug safety notice can be viewed here.

Contact details 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 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.

 



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