CLASS 4 CAUTION IN USE - NAPROSYN TABLETS (ALL STRENGTHS), NAPROSYN EC 500MG GASTRO-RESISTANT TABLETS

Additional to the batches included in the previous Class 4 Medicines Notification (reference EL(22)A/05), Atnahs Pharma UK Limited have informed us that the Patient Information Leaflets (PILs) in the above batches are missing information

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-atnahs-pharma-uk-limited-naprosyn-tablets-all-strengths-naprosyn-ec-500mg-gastro-resistant-tablets-el-22-a-slash-09?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=bf8465ff-1733-4206-8118-29be77b0cde5&utm_content=immediately

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

Further Information

For medical information queries or stock control queries, please contact: info@pharmanovia.com

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

Company Led Recall - Alimentum and Elecare

Abbott Nutritional Ltd is recalling as a precautionary measure.

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.

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

Class 2 Recall - Fluorouracil Injection, 50 mg/ml, solution for injection (2500mg/50ml vial)

Medac GmbH (t/a medac Pharma LLP) are recalling certain product batches as a precautionary measure due to visual detection of glass lamellae particles during an ongoing stability study.

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-medac-gmbh-t-slash-a-medac-pharma-llp-fluorouracil-injection-50-mg-slash-ml-solution-for-injection-2500mg-slash-50ml-vial-el-22-a-08?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=72e19d5c-b6d8-4bd5-9cd1-ac0ab189f3d0&utm_content=immediately

Further Information

For more information, medical or supply enquiries, please contact Medac Pharma LLP by email to info@medacpharma.co.uk or telephone 01786 458086

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 2 Recall - Efudix 5% W/W Cream (2 X 20g) Pack

Uni Health Distribution is aware of a potential issue where the leaflet contained within Efudix 5% w/w cream (2 x 20g) pack, batch 80193439/B may be incorrect.

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-uni-health-distribution-efudix-5-percent-w-slash-w-cream-el-22-a-07?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=17cc5756-8170-4e39-ac3b-145bbec7c060&utm_content=immediately

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

Further Information

For more information, please contact or email Margaret Fairney margaret@ennogen.com

For medical information queries, please contact or email Margaret Fairney margaret@ennogen.com

For supply queries, please contact Davide Rinaldi purchasing@ennogen.com

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

Class 2 Recall - Water for injections 100ml x 25 vials

Hameln Pharma Ltd is recalling a batch of a product as a precautionary measure as remaining vials may no longer be in line with the licensed product specification.

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-hameln-pharma-ltd-water-for-injections-bp-100ml-vial-el-22-a-06?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=a0cd0c19-6da8-4f3e-b4c1-e3e2fde990d1&utm_content=immediately

Further Information

For more information or supply queries, please contact or email Hameln pharma ltd customer services on +44 (0)1452 621 661 or customer.services@hameln-pharma.co.uk

For medical information queries, please contact or email Hameln pharma ltd Medicines Information on +44 (0)1452 621 661 or drug.safety@hameln-pharma.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.

Company Led Recall - Bucain Hyperbar 5mg/Ml Solution For Injection (Unlicensed Medicine)

Mawdsley-Brooks & Company Limited (UK importer) is recalling the above batch as a precautionary measure due out of specification result for pH that was identified during routine stability testing.

This product is supplied to hospital pharmacies only.

This recall is being issued as a company-led recall due to the limited number of packs distributed, and the UK importer has full traceability of the product’s onward distribution.

Remaining stock of the above batch should be quarantined and returned to the UK importer directly.

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/company-led-medicines-recall-bucain-hyperbar-5mg-slash-ml-solution-for-injection-unlicensed-medicine-clmr-22-a-slash-01?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=59fedfa5-2201-4d43-9808-31e5d67cce88&utm_content=immediately

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

For more information please contact Charlotte Ray: charlotte.ray@mawdsleys.co.uk  or Tel: 07342 949 102

Class 4 Drug Caution In Use - NAPROSYN TABLETS (ALL STRENGTHS), NAPROSYN EC 250MG GASTRO-RESISTANT TABLETS

Atnahs Pharma UK Limited have informed us that the Patient Information Leaflets (PILs) that have been provided with the below batches are missing information.

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-atnahs-pharma-uk-limited-naprosyn-tablets-all-strengths-naprosyn-ec-250mg-gastro-resistant-tablets-el-22-a-slash-05?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=8020daee-edf4-40b6-942b-a17672984fb1&utm_content=immediately

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

Further Information

For medical information queries or stock control queries, please contact: info@pharmanovia.com

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

Class 4 Drug Caution In Use - IBUPROFEN 400MG TABLETS

Flamingo Pharma UK Ltd have identified an error relating to the embossed batch number on some cartons of Ibuprofen 400mg tablets. The batch number is illegible on some cartons and poses a risk to traceability in the event of a future recall or a medical enquiry. The batch numbers on the blisters within the cartons are clear and present. Additionally, the expiry date is still visible and clearly marked on the carton and blister.

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-flamingo-pharma-uk-ltd-ibuprofen-400mg-tablets-el-22-a-slash-04?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=4e98e5c4-603a-4941-8d14-a508d8879d6f&utm_content=immediately

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

Further Information:

For medical information safety@flamingopharma.co.uk or general product enquiry sales@flamingopharma.co.uk +44 (0) 7733522465

Or

Mawdsley Brooks & Co Ltd

Overlabellingcustomerservices@mawdsleys.co.uk or 01302 553064

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

Class 4 Drug Caution in use - PIPERACILLIN/TAZOBACTAM 4 G/0.5G POWDER FOR SOLUTION FOR INFUSION

Antibiotice SA have identified an error on PIL of the below batches regarding the sodium content

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-antibiotice-sa-piperacillin-slash-tazobactam-4g-slash-0-dot-5-g-powder-for-solution-for-infusion-el-22-a-slash-03?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=5c74d887-61f6-4a04-b8a1-a44bdd00e295&utm_content=immediately

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

Further Information

For medical information please contact:

medical@antibiotice.ro

For stock control queries please contact:

shaunak@esteve.com

johnson@esteve.com

dromard@esteve.com

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

Class 4 Drug Caution in use - KABIVEN EMULSION FOR INFUSION

Fresenius Kabi Limited have identified an error in the infusion the infusion bag packaged into the below batches. In the list of ingredients section printed onto the bag, the amount of Glucose 19 %: Glucose (monohydrate) has been incorrectly declared as 110 g, the actual amount is 220g

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-fresenius-kabi-limited-kabiven-emulsion-for-infusion-el-22-a-slash-02?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=a03ef0f0-48bd-41ad-81db-62dc0b48b245&utm_content=immediately     

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

Further Information

For more information or medical information queries please contact: Medical.Information-UK@fresenius-kabi.com

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