CLASS 2 RECALL - VARIOUS MARKETING AUTHORISATION HOLDERS AND PARALLEL DISTRIBUTOR COMPANIES

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:

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-34?utm_medium=email&utm_campaign=govuk-notifications&utm_source=51215d28-2f33-4366-a0f9-0eb7cd46f26b&utm_content=immediately

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-34?utm_medium=email&utm_campaign=govuk-notifications&utm_source=1bddc3b6-a77c-46a3-9a16-7732942ac3dc&utm_content=immediately   

Aventis Pharma Limited T/A Sanofi

Parallel Distributors

Chemilines Ltd

Drugsrus Ltd (Repackaged by P.I.E Pharma Ltd)

Lexon (UK) Ltd

BR Lewis Pharmaceuticals Ltd (Repackaged by Doncaster Pharmaceuticals Group Ltd)

Gowrie Laxmico Ltd T/A B&S Healthcare

Quadrant Pharmaceuticals Ltd (Repackaged by Maxearn Ltd)

OPD Laboratories Ltd

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.

Class 4 Drug Caution in use - MOMETASONE FUROATE 50 MICROGRAM / DOSE NASAL SPRAY, SUSPENSION

PilsCo Ltd. have identified a error relating to the wording on the outer carton label. The label affixed on the bottle states: ‘use within 2 weeks of first use’, instead of the correct label statement which should be: ‘use within 2 months of first use

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-mometasone-furoate-50-microgram-slash-dose-nasal-spray-suspension-pilsco-ltd-el-21-a-slash-33?utm_medium=email&utm_campaign=govuk-notifications&utm_source=e049222e-87bd-466b-af5c-870967570da8&utm_content=immediately    

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

Further Information

For more information, medical information queries or stock control queries, please contact: Nigel Kelly Nigel@ethigen.co.uk 013555 98155

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

CLASS 3 RECALL - METHADONE TAB 5MG (PHYSEPTONE 5MG TABLETS)

Martindale Pharma is recalling the below batch of Methadone 5mg tablets as a precautionary measure due to the discolouration of the PVdC film in a small number of blister pockets

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-martindale-pharma-an-ethypharm-group-company-methadone-5mg-tablets-slash-physeptone-5mg-tablets-el-21-a-slash-31?utm_medium=email&utm_campaign=govuk-notifications&utm_source=c480fd76-d520-4a64-9570-f410b38c7b35&utm_content=immediately   

Further Information

For more information please contact:

Customer Services for stock control enquiries: Licensed@ethypharm.com

or for Medical Information enquiries: medinfo@martindalepharma.co.uk

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 3 RECALL - METHADONE TAB 5MG (PHYSEPTONE 5MG TABLETS)

Martindale Pharma is recalling the below batch of Methadone 5mg tablets as a precautionary measure due to the discolouration of the PVdC film in a small number of blister pockets

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-martindale-pharma-an-ethypharm-group-company-methadone-5mg-tablets-slash-physeptone-5mg-tablets-el-21-a-slash-31?utm_medium=email&utm_campaign=govuk-notifications&utm_source=c480fd76-d520-4a64-9570-f410b38c7b35&utm_content=immediately   

This product is a Schedule 2 Controlled Drug, so please use the Returns Portal for any recalled stock you may need to return to ensure there is authorization to return. When you are completing the portal if you are returning a split pack Please include exact number of tablets you are returning. If you are unable to use the Returns Portal please call Customer Services for assistance.

Further Information

For more information please contact:

Customer Services for stock control enquiries: Licensed@ethypharm.com

or for Medical Information enquiries: medinfo@martindalepharma.co.uk

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 - IKERVIS EYE DROPS 0.1% & VERKAZIA 0.1% EYE DROPS UD

SANTEN Oy (trading as Santen UK Limited) are recalling the below batches of products as a precautionary measure due to detection of particles/crystals of the active pharmaceutical ingredient ciclosporin. These particles have been detected following microscopic evaluation during stability monitoring

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-santen-oy-trading-as-santen-uk-limited-and-parallel-distributor-ikervis-1-mg-slash-ml-eye-drops-emulsion-and-verkazia-1-mg-slash-ml-eye-drops-emulsion-el-21-a-slash-30?utm_medium=email&utm_campaign=govuk-notifications&utm_source=ed7060ba-57ef-42eb-89b1-ac5b77c8be8a&utm_content=immediately  

Alliance do not stock the above products so we will not be accepting Customer returns on this recall.

Further Information

Santen UK Limited

For more information, please contact +44 (0)1727 615 110 or email enquiries@santen.co.uk

For medical information queries, please contact 0345 075 4863 or email medinfo@santen.co.uk

For supply queries, please contact AAH Customer services at 0344 561 8899

Orifarm A/S

For all enquiries please contact:

Paul Tobin (Responsible Person) on 07583577513 or email at paul.tobin@orifarm.com

Steven Cross (UK Parallel Import Sales Manager) on 07498975920 or email at steven.cross@orifarm.com

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

Class 4 Drug Caution in use - SLENYTO 1 MG AND 5MG PROLONGED RELEASE TABLETS

Flynn Pharma Ltd, distributors of Slenyto 1 mg and 5mg prolonged release tablets would like to notify you of an error with the patient information leaflets (PILs) that have been packaged in the below batches of products. These were an older version of the PIL which did not include the most up to date safety information

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-slenyto-1-mg-and-5mg-prolonged-release-tablets-distributed-by-flynn-pharma-ltd-el-21-a-slash-29?utm_medium=email&utm_campaign=govuk-notifications&utm_source=918a7eae-bd86-4833-899a-5114d92b0980&utm_content=immediately      

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

Further Information

For more information, medical information queries or replacement PIL enquiries, please contact:

Flynn Pharma Ltd Medical Information Department on 01438 727822, email – medinfo@flynnpharma.com.

For stock control queries, please contact: Flynn Pharma Ltd on 01438 727822

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

COMPANY-LED DRUG ALERT - DOTAREM SOLUTION FOR INJECTION (10ML VIAL)

Guerbet Laboratories Ltd is recalling the below batches of Dotarem 10ml vials, due to the potential risk of a sterility break, based on the evidence of external leaks of the solution (dry product on the external surface of the vials)

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/company-led-medicines-recall-dotarem-solution-for-injection-10ml-vial-pl-12308-slash-0016?utm_medium=email&utm_campaign=govuk-notifications&utm_source=6e2cf2cc-77cb-4717-a214-e7df6d710c9c&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 James Bradley (GDP RP):

james.bradley@guerbet.com

Company Contact for stock enquiries

For stock information enquiries,

UK Customer Services

uk.sales@guerbet.com

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

CLASS 2 RECALL - COLD & FLU RELIEF CAPSULES (GSL) – VARIOUS LIVERIES

Perrigo are recalling the below batches of Cold & Flu Relief Capsules (GSL) – Various Liveries, due to an error on the leaflet and carton for the products as noted above. The leaflet and carton incorrectly states that for Adults, the elderly and children 12 years and over, the dose should be 2 capsules every 4 to 6 hours as required, up to a maximum of 12 capsules in any 24 hour period. The leaflet and carton dosage instructions are those which were in use prior to the paediatric paracetamol posology update implemented by the MHRA

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-cold-and-flu-relief-capsules-gsl-various-liveries-wrafton-laboratories-limited-trading-as-perrigo-el-21-a-slash-28?utm_medium=email&utm_campaign=govuk-notifications&utm_source=f44f6fc5-9c7f-4cc3-b3ab-df07db229afc&utm_content=immediately   

Further Information

For more information, please contact: Perrigo Customer Services Team on 0203 598 9603 or UKLOCustomerService@perrigo.com

For stock control queries, please contact: Perrigo Service Team on 01226 704711 or customerservice@perrigouk.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 4 Drug Caution in use - MITOCIN (MITOMYCIN) 20MG POWDER FOR SOLUTION FOR INJECTION/INFUSION

Vygoris Limited has informed the MHRA that some vials of Mitocin 20mg powder for solution for injection/infusion or intravesical use may contain subvisible particles above the current specifications after reconstitution (>10µm: NMT 6000/vial), initially identified during stability studies. Vygoris Limited has confirmed that a single-use filtration device called the Millex® HV (0.45 μm/PVDF) - Syringe Filter will be included in each delivery of the product

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-vygoris-limited-mitocin-mitomycin-20mg-powder-for-solution-for-injection-slash-infusion-or-intravesical-use-el-21-a-slash-27?utm_medium=email&utm_campaign=govuk-notifications&utm_source=23f29568-2411-48f9-bc43-7b69aed25c18&utm_content=immediately                  

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

Further Information

For medical information queries, please contact:

Lucy Owen,

ProductLifeGroup

Tel: +44 (0) 1223 402660

Email: lowen@productlife-group.com

For more information or stock control queries, please contact:

Hussain Tahan

Vygoris Ltd

Tel: 020 3865 1682

Email: qualitylimited@vygoris.com

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

CLASS 4 CAUTION IN USE - SYRENIRING 0.12MG/0.015MG 24 HR

Crescent Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the below batches is missing important safety relevant text changes

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-crescent-pharma-ltd-syreniring-0-120-mg-0-015-mg-per-24-hours-vaginal-delivery-system-el-20-a-36?utm_medium=email&utm_campaign=govuk-notifications&utm_source=8b7c3acf-aee7-4d91-8b27-85a8e19f72c8&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: Crescent Pharma Ltd. Medical Information Department on +00351 214643225, via email on tiago.barca@pharsolution.com or +44 (0) 1256 772740..

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