CLASS 2 RECALL - VARIOUS SUPPLIER & PRODUCTS

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

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-various-marketing-authorisation-holders-and-parallel-distributor-companies-irbesartan-containing-products-el-21-a-slash-19?utm_medium=email&utm_campaign=govuk-notifications&utm_source=7fde90cb-19d4-417d-888c-d7769dcf3f3f&utm_content=immediately   

Please can you ensure that your stores quarantine the product listed below.

Aventis Pharma Limited T/A Sanofi

Zentiva

Parallel Distributors

Doncaster Pharmaceuticals Group Ltd

MPT Pharma Limited

PCO Manufacturing Ltd

Gowrie Laxmico Ltd T/A B&S Healthcare

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

EL (21)A/19 Page 4 of 4

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.

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.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

FIELD SAFETY NOTICE - ACCU-CHEK AVIVA & ACCU-CHEK PERFORMA

Roche Diabetes Care has received complaints from one hospital in the United States alleging unexpected results (such as positively biased, or falsely too high, results) when using test strip vials which have opened while still in a sealed carton. The Roche investigation showed that, in very rare circumstances, it is possible that a vial can open in a sealed carton while in transit. This could happen to Accu-Chek Aviva / Accu-Chek Performa test strips, when they are shipped at elevated temperature ( ≥45°C or 113°F) AND when the carton is dropped or handled roughly during the transit and distribution process. It is only when these two conditions occur in combination that the failure mode has been observed

MHRA drug alert link: N/A  

This is a caution in use only we are not accepting stock returns.

If you have any affected product, please dispose of the test strips immediately.

Roche Diabetes Care will provide test strip replacements to users who have purchased vials that were open within the sealed carton.

To obtain replacement from Roche Diabetes Care, please call Roche Diabetes Care Customer Careline at UK: 0800 701 000* or Ireland: 1 800 709 600*

If you have any questions, then please contact your local Service Centre Customer Services team.

COMPANY LED CLASS 2 RECALL - PI APROVEL TAB 150MG

Potentially contaminated with an impurity

MHRA drug alert link: N/A

For further information please contact:

Sales and customer service

Rebecca Platts: Rebecca.platts@doncatser-pharm.com

01302552961

Quality Assurance

Richard Gore: Richard.Gore@doncaster-pharm.com

01302554805 or out of hours 07736297267  

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.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

FIELD SAFETY NOTICE - JELONET 5X5CM

Smith & Nephew Medical Ltd. has initiated a field action to voluntarily remove multiple lots of the JELONET 5x5CM. There is a potential for a sterile barrier breach and paraffin leakage due to manufacturing error

MHRA drug alert link: N/A          

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.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

Class 4 Drug Caution in use - AMOXICILLIN SF SOLN 500MG/5ML

Brown & Burk UK Limited would like to notify you of an error regarding specific batches of Amoxicillin 500 mg/ 5 ml Powder for oral suspension, sold and distributed in the UK. The product information incorrectly states the quantity of the excipient sodium benzoate. The actual quantity of sodium benzoate is 3.75mg/5ml. On the PIL it is incorrectly reported as 7.5mg/5ml and in the SmPC it is 15mg/5ml (1.5mg/ml)

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-amoxicillin-500-mg-slash-5-ml-powder-for-oral-suspension-pl-25298-slash-0248-el-21-a-slash-18?utm_medium=email&utm_campaign=govuk-notifications&utm_source=f29a9822-cac1-4ec1-b4d9-743ca644267c&utm_content=immediately   

This may have been supplied by AHDL. Unfortunately we are not providing specific batch information you will  be required to follow the instructions as per the drug alert.

This is a caution in use only we are not accepting stock returns.

For more information, medical information queries please contact:

Email: pv@bbukltd.com

For stock enquiries please contact:

Email: customercare@bbukltd.com

Tel: 0203 384 7188.

Company Led - Field Safety Notice - BAUSH & LOMB

Bausch + Lomb is conducting a recall of certain lots of Biotrue®, ReNu® and ReNu® MultiPlus Boston® and Boston® Simplus Multi-action, Sensitive Eyes™ and EasySept® contact lens solution since we cannot confirm the compliance of the supplier’s sterilization process used for some components of these products.

MHRA drug alert link: N/A   

If you have any questions, please contact Bausch + Lomb Customer Service.

Email: Pharma_CS@bausch.com

Phone: 0845 602 2350

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.

Class 4 Drug Caution in use - SEVREDOL 10 MG AND 20MG TABLETS

Napp Pharmaceuticals Limited would like to notify you of an error regarding specific batches of Sevredol 10 mg Tablets and Sevredol 20 mg Tablets, sold and distributed in the UK. The error identified relates to approved safety-related variations to the PIL that were not implemented, resulting in an older version of artwork being used and packed within finished batches

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-sevredol-10-mg-and-20mg-tablets-pl-16950-slash-0063-pl-16950-slash-0064-el-21-a-slash-17?utm_medium=email&utm_campaign=govuk-notifications&utm_source=584858cd-3f8d-4b3f-8bf2-768eb8caa361&utm_content=immediately

Alliance healthcare do not stock this product therefore we are not accepting stock returns.

For more information, medical information queries or replacement PIL enquiries, please contact: medicalinformationuk@napp.co.uk

For stock control queries, please contact:supplies.uk@napp.co.uk

If you have any questions, then please contact your local Service Centre Customer Services team.

Class 4 Drug Caution in use - TETRALYSAL 300MG HARD CAPSULES.

Galderma UK would like to notify you of an error identified by Galderma regarding specific batches of Tetralysal 300mg Hard Capsules, sold and distributed in the UK. The error identified relates to approved safety-related variations to the PIL that were not implemented, resulting in an older version of artwork being used and packed within finished batches. Additional warnings, precautions and side effects have been updated in the latest version of the PIL

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-tetralysal-300mg-hard-capsules-pl-10590-slash-0019-el-21-a-slash-16?utm_medium=email&utm_campaign=govuk-notifications&utm_source=b7dd4d76-0102-4c23-aef5-75c8db9d349c&utm_content=immediately

This may have been supplied by AHDL. Unfortunately we are not providing specific batch information you will  be required to follow the instructions as per the drug alert.

This is a caution in use only we are not accepting stock returns.

For more information, medical information queries or replacement PIL enquiries, please contact: medinfo.uk@galderma.com

For stock control queries, please contact: sales.uk@galderma.com

If you have any questions, then please contact your local Service Centre Customer Services team

CLASS 2 RECALL - XOMOLIX 2.5MG/ML SOLUTION FOR INJECTION

Kyowa Kirin Limited is recalling the below batches as a precautionary measure, due to the reports of glass and cellulose fibre contamination, which was identified during stability and reference sample inspection

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-kyowa-kirin-limited-xomolix-2-dot-5-mg-slash-ml-solution-for-injection-el-21-a-slash-15?utm_medium=email&utm_campaign=govuk-notifications&utm_source=3e23300a-19ec-459c-9311-e77b781e4d45&utm_content=immediately   

Further information

For Stock control enquiries please contact

Karen Murray, Commercial Manager

Telephone: +44 (0) 1896 661665 / Mobile: +44 (0) 7712 001288

Email: karen.murray@kyowakirin.com

For Medical information enquiries please contact

Medical Information Direct Line: + 44 (0)1896 664 000

Email: medinfo@kyowakirin.com

For Quality information please contact

Martin Smith (Responsible Person)

Telephone: Mobile: +44 7904671807

Email: Martin.Smith@kyowakirin.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.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit..

If you have any questions, then please contact your local Service Centre Customer Services team.

CLASS 2 RECALL - IRBESARTAN-CONTAINING AND LOSARTAN-CONTAINING PRODUCTS

Bristol Laboratories Limited, Brown & Burk UK Ltd and Teva UK Ltd are recalling the below batches of products 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

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-bristol-laboratories-limited-brown-and-burk-uk-ltd-teva-uk-ltd-irbesartan-containing-and-losartan-containing-products-el-21-a-slash-14?utm_medium=email&utm_campaign=govuk-notifications&utm_source=6bdefacf-875e-4062-aa0b-ebeba6a9dc5d&utm_content=immediately   

Bristol Laboratories Limited

Brown and Burk UK Limited

Teva UK Limited

Further Information

Bristol Laboratories Limited

For more information or medical information queries please contact notifications@bristol-labs.co.uk

For supply queries, please contact notifications@bristol-labs.co.uk

Brown & Burk UK Ltd

For more information or medical information queries please contact pv@bbukltd.com

For supply queries, please contact customercare@bbukltd.com or 0203 384 7188

Teva UK Limited

For more information or medical information queries please contact Teva Medical Information at

medinfo@tevauk.com or 0207 540 7117

For supply queries, please contact Teva Customer Solutions at customer.services@tevauk.com or

0800 590502

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.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.

If you have any questions, then please contact your local Service Centre Customer Services team.