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.

CLASS 1 RECALL - CO-CODAMOL EFF TAB 30/500MG

Zentiva Pharma UK Limited is recalling the below batch of Co-Codamol 30/500 Effervescent Tablets as a precautionary measure due to an issue with the homogeneity of the batch. This issue means that there is the potential for some tablets to have too little active ingredients (codeine phosphate and paracetamol) in them and some tablets to contain too much active ingredients. The current investigation has highlighted that tablets have been identified where the content of both codeine and paracetamol is less than the label claim.

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-co-codamol-30-slash-500-effervescent-tablets-batch-1k10121-zentiva-pharma-uk-ltd-due-to-precautionary-risk-of-causing-overdose-natpsa-slash-2021-slash-0?utm_medium=email&utm_campaign=govuk-notifications&utm_source=33da5f41-be1d-4bf9-a5ef-3016b2913e73&utm_content=immediately

We would like to draw your attention to the following quote from the MHRA: MHRA Chief Quality and Access officer, Dr Samantha Atkinson, said:

Patient safety is always our priority. It is vitally important that people urgently check their packs of Zentiva Pharma UK Ltd Co-codamol 30/500 Effervescent Tablets and if the batch number corresponds to 1K10121, they should stop using them and return them to their pharmacy for a replacement immediately.

For more information or medical information queries please contact 0800 0902408 or email UKMedInfo@zentiva.com.

For supply queries, please contact 0844 8793188 or email 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.

COMPANY-LED DRUG ALERT – Alliance do not stock

The importer and distributor of the below products (Eaststone Limited) has informed us of reports that two affected batches may be contaminated with mould. Therefore, these batches are being recalled as a precautionary measure. This recall is being issued as a company-led recall due to the limited number of packs distributed, and Eaststone Limited have full traceability of the onward distribution by their customers.

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

Alliance do not stock these products and therefore we are not accepting stock returns.

Company Contact for medical information enquiries

For medical information enquiries, please contact: Omair Sattar

Email: omair.sattar@eaststone.co.uk

Tel: 01942 841 704

Company Contact for stock enquiries

For stock information enquiries, please contact: Omair Sattar

Email: omair.sattar@eaststone.co.uk

Tel: 01942 841 704

CLASS 3 RECALL - CARBIMAZOLE TAB 10MG & 15MG

Advanz Pharma is recalling the below batches of Carbimazole tablets as a precautionary measure, due to an out of specification observation for tablet appearance of samples during routine stability testing. Based on the investigation performed, the observed defect was related to oxidation of the excipient red iron oxide on the surface of the tablets, due to a lack of proper mixing during the manufacturing process. There is no safety or efficacy issues as a result of this observation.

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-intrapharm-laboratories-ltd-kolanticon-gel-500ml-el-21-a-slash-01?utm_medium=email&utm_campaign=govuk-notifications&utm_source=1c3cadd1-c259-4e77-b3e8-c13faf584fe2&utm_content=immediately  

Further Information

For more information or medical information queries please contact +44 (0) 8700 70 30 33 , or email medicalinformation@advanzpharma.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.

Company Led - DRUG ALERT - LYSAKARE 25 G / 25 G SOLUTION FOR INFUSION

Advanced Accelerator Applications Ltd is recalling the below batch of LysaKare 25 g / 25 g solution for infusion (PLGB 35145/0005) as it was identified during the inspection process by the manufacturer that a small number of bags were observed to be leaking..”

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/company-led-medicines-recall-lysakare-25-g-slash-25-g-solution-for-infusion-plgb-35145-slash-0005?utm_medium=email&utm_campaign=govuk-notifications&utm_source=125027c5-2625-4ae7-a249-7c9dc4b72260&utm_content=immediately   

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

Company contact for medical information enquiries

For medical information enquiries, please contact: Advanced Accelerator Applications (UK & Ireland) Ltd infomed@adacap.com.

Company contact for stock enquiries

For stock information enquiries contact Advanced Accelerator Applications (UK & Ireland) Ltd by emailing: customersvc.aaauk@novartis.com, tel. +44(0)20 72585200

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