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.

COMPANY LED FIELD SAFETY NOTICE- ARTELAC REBALANCE 10ML

The product recall for the affected batch is due to the incorrect shipment of products intended for the Belgian market to the UK/Ireland markets. As a result part of the shipments for batch 520 of Artelac Rebalance contain products with German/French/Dutch labelling. The labelling and Instructions for Use should be understood by all users in their country official language. Therefore German/French/Dutch labelled products must not be distributed in UK or Ireland

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 2 RECALL - BRICANYL AMP 0.5MG/1ML

AstraZeneca UK Limited is recalling the below batch of Bricanyl 0.5mg/ml solution for injection or infusion as a precautionary measure due to out of specification results for a routinely tested known impurity during stability testing

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-astrazeneca-uk-limited-bricanyl-injection-0-dot-5-mg-slash-ml-solution-for-injection-or-infusion-pl-17901-slash-0112-el-21-a-slash-12?utm_medium=email&utm_campaign=govuk-notifications&utm_source=42605459-ef94-4b7e-bb39-33e83dbc6d74&utm_content=immediately   

Please note that Alliance Healthcare do not stock and we are therefore not accepting stock returns.

For more information or medical information queries please contact

Tel: +44 (0) 0800 783 0033

Email: medical.informationuk@astrazeneca.com

For supply queries, please contact

Tel: +44 (0) 800 783 0033 (option 1)

Email: supply.chain@astrazeneca.com.

FIELD SAFETY NOTICE - HISTOACRYL ADH TISSUE BLU

: B. Braun have detected new additional batches where the adhesive could not polymerize completely after its application. The tested products did not show the normal curing behaviour, providing lower adhesive forces than expected.

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.

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

Class 4 Drug Caution in use - SYONELL 250MG & 500MG GASTRO-RESISTANT TABLETS

: Lupin Healthcare (UK) Limited has informed us of a discrepancy with the product packaging for several batches of Syonell 250mg Gastro-Resistant Tablets and Syonell 500mg Gastro-Resistant Tablets. This discrepancy relates to the incorrect amount of active pharmaceutical ingredient (valproate semisodium) printed on the outer packaging

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-syonell-250mg-gastro-resistant-tablets-pl-35507-slash-0191-syonell-500mg-gastro-resistant-tablets-pl-35507-slash-0192-el-21-a-slash-11?utm_medium=email&utm_campaign=govuk-notifications&utm_source=58b8fb90-a905-45be-8b0f-5c608a23c4ba&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 or medical information queries, please contact: +44 (0) 1565 751 378 Option 1 or Pharmacovigilance Department at EU-PV@lupin.com

For stock control queries, please contact: 44 (0) 1565 751 378 Option 2 or information@lupin.com

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

Company Led - Class 2 Recall (Customer Level) SMA Wysoy Soya Infant Formula 800g

The recall of SMA Wysoy is a food safety recall due to potential presence of foreign bodies (pieces of plastic scoops). Nestlé has undertaken it on a voluntary basis.

The affected products' details are as follows:

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