Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products, EL(21)A/34

Block 1

Specific batches of products supplied by Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity.

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)

Co-Aprovel 300 mg/12.5 mg Film-Coated Tablets, EU/1/98/006/017, (PLGB 04425/0792)

Company name: Chemilines Ltd

Aprovel 150mg Tablets, EU/1/97/046/004

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

Co-Aprovel 150mg/12.5mg Tablets, EU/1/98/086/001

Co-Aprovel 300mg/12.5mg Tablets, EU/1/98/086/004

Company name: Drugsrus Ltd (Repackaged by P.I.E Pharma Ltd)

Co-Aprovel 150mg/12.5mg Tablets, EU/1/98/086/001

Company name: Lexon (UK) Ltd

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

Company name: BR Lewis Pharmaceuticals Ltd (Repackaged by Doncaster Pharmaceuticals Group Ltd)

Aprovel 150mg Tablets, EU/1/97/046/004

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

Co-Aprovel 150mg/12.5mg Tablets, EU/1/98/086/012

Company name: Gowrie Laxmico Ltd T/A B&S Healthcare

Aprovel 150mg Tablets, EU/1/97/046/004

Co-Aprovel 150mg/12.5mg Tablets, EU/1/98/086/001

Co-Aprovel 300mg/25mg Tablets, EU/1/98/086/024

Company name: Quadrant Pharmaceuticals Ltd (Repackaged by Maxearn Ltd)

Aprovel 150mg Tablets, EU/1/97/046/004

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

Company name: OPD Laboratories Ltd

Aprovel 150mg Tablets, EU/1/97/046/004

Co-Aprovel 150mg/12.5mg Tablets, EU/1/98/086/001

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.

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 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.

To access the full recall: Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Aprovel/Co-Aprovel-containing products, EL (21)A/34