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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