MHRA Class 2 Medicines Recall Irbesartan containing products

MHRA Class 2 Medicines Recall Irbesartan containing products

November 30, 2021

Class 2 MHRA Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products

Drug alert number: EL (21) A/34

Date issued: 30 November 2021

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:

Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products

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.

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

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 Jul 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 2023 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 2023 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 Oct 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 Expiry Date Pack Size First Distributed
FT022 061R1441 Jan 2023 28 Jul 2020
FT022 06T0238 Jan 2023 28 Jun 2020
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 Expiry Date Pack Size First Distributed
FT012 061R1475 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 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 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
ETO39 4908R Mar 2022 28 Sep 2019

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

Manufacturer’s Batch Number Parallel Distributor’s Batch Number 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 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 Expiry Date Pack Size First Distributed
FT020 FT020/1 Feb 2023 28 Mar 2021

Advice for healthcare professionals

  • Stop supplying the above batches immediately. Quarantine all 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.

Full drug alert can be viewed here.

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.



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