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

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

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

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

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

Zentiva

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

Parallel Distributors

Doncaster Pharmaceuticals Group Ltd

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

MPT Pharma Limited

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

PCO Manufacturing Ltd

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

Gowrie Laxmico Ltd T/A B&S Healthcare

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

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

Brief description of 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 to 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.

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 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.

 

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