Class 2 Recall
Important update:
Further to the recall below, the MHRA have sent an updated version with the below changes.
Change made:
Batch ET042/2156 has been added to BR Lewis Pharmaceuticals, 150mg Aprovel section (this batch number has been added in the table below).
Updated link:
Specific batches of the below 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
Aventis Pharma Limited T/A Sanofi
Pip code | Product description | Supplier | Batch Numbers |
ALLIANCE DO NOT STOCK | CO-APROVEL FC 150MG/12.5MG | SANOFI | 9R1PC |
ALLIANCE DO NOT STOCK | CO-APROVEL FC 300MG/12.5MG | SANOFI | 9R1P9 |
Pip code | Product description | Livery | Batch Numbers |
8449241 | PI APROVEL TAB 150MG | CHEMILINES | FT022/001 FT022/002 FT022/003 |
7108988 | PI APROVEL TAB 300MG | CHEMILINES | FT020/001 |
7028699 | PI CO-APROVEL FC 150MG/12.5MG | CHEMILINES | FT020/001 |
7028681 | PI CO-APROVEL FC 300MG/12.5MG | CHEMILINES | FT037/001 |
Pip code | Product description | Livery | Batch Numbers |
ALLIANCE DO NOT STOCK | PI CO-APROVEL FC 150MG/12.5MG | DRUGSRUS LTD (REPACKAGED BY P.I.E PHARMA LTD) | K/066 |
Lexon (UK) Ltd
Pip code | Product description | Livery | Batch Numbers |
ALLIANCE DO NOT STOCK | PI APROVEL TAB 300MG | LEXON (UK) LTD | FT027 |
BR Lewis Pharmaceuticals Ltd (Repackaged by Doncaster Pharmaceuticals Group Ltd)
Pip code | Product description | Livery | Batch Numbers |
8449241 | PI APROVEL TAB 150MG | BR LEWIS PHARMACEUTICALS LTD (REPACKAGED BY DONCASTER PHARMACEUTICALS GROUP LTD) | ET042/2156 FT022/2994 FT022/3112 FT040/3218 FT052/3228 |
7108988 | PI APROVEL TAB 300MG | BR LEWIS PHARMACEUTICALS LTD (REPACKAGED BY DONCASTER PHARMACEUTICALS GROUP LTD) | FT027/3124 FT027/3079 |
7028699 | PI CO-APROVEL FC 150MG/12.5MG | BR LEWIS PHARMACEUTICALS LTD (REPACKAGED BY DONCASTER PHARMACEUTICALS GROUP LTD) | 9R1PC |
Gowrie Laxmico Ltd T/A B&S Healthcare
Pip code | Product description | Livery | Batch Numbers |
ALLIANCE DO NOT STOCK | PI APROVEL TAB 150MG | GOWRIE LAXMICO LTD T/A B&S HEALTHCARE | 06R1441 06T0238 07R0792 11R0446 05T0766 05T0767 10R0284 |
ALLIANCE DO NOT STOCK | PI CO-APROVEL FC 150MG/12.5MG | GOWRIE LAXMICO LTD T/A B&S HEALTHCARE | 06R1475 08R0102 10R0532 08R0074 |
ALLIANCE DO NOT STOCK | PI CO-APROVEL 300MG/25MG TABLETS | GOWRIE LAXMICO LTD T/A B&S HEALTHCARE | 05R1210 |
Quadrant Pharmaceuticals Ltd (Repackaged by Maxearn Ltd)
Pip code | Product description | Livery | Batch Numbers |
ALLIANCE DO NOT STOCK | PI APROVEL TAB 150MG | QUADRANT PHARMACEUTICALS LTD (REPACKAGED BY MAXEARN LTD) | 7790R 1390T 1655T 1392T 1652T 9494T 9619T 1905U 4908R |
ALLIANCE DO NOT STOCK | PI APROVEL TAB 300MG | QUADRANT PHARMACEUTICALS LTD (REPACKAGED BY MAXEARN LTD) | 9486T |
OPD Laboratories Ltd
Pip code | Product description | Livery | Batch Numbers |
ALLIANCE DO NOT STOCK | PI APROVEL TAB 150MG | OPD LABORATORIES LTD | FT051/1 FT051/2 FT051/3 FT052/1 |
ALLIANCE DO NOT STOCK | PI CO-APROVEL FC 150MG/12.5MG | OPD LABORATORIES LTD | FT020/1 |
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.
Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.
If you have any questions, then please contact your local Service Centre Customer Services team.