MHRA Class 2 Medicines Recall Irbesartan containing products
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.
