company-led recall: Gemcitabine Solution for Infusion 2000mg/200ml

Sun Pharma UK Ltd has informed the MHRA of a labelling issue with one batch of Gemcitabine 2000mg/200ml infusion.

MHRA drug alert date: 7th September 2023

MHRA drug alert link:  https://www.gov.uk/drug-device-alerts/company-led-medicines-recall-sun-pharma-uk-ltd-gemcitabine-10mg-slash-ml-solution-for-infusion-pl-31750-slash-0062-single-dose-infusion-bag-2000mg-slash-200ml-clmr-23-a-slash-06

Further Information

For medical information enquiries, please contact:

Email: medinfoeurope@sunpharma.com

Tel: 0208 848 5052

For stock information enquiries, please contact: Sun Pharma UK Customer Services

Email: Cserv.uk@sunpharma.com

Tel: 0208 848 5050

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 Caution in use- Duraphat 5000ppm toothpaste

Colgate-Palmolive (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL), carton and tube of the batches of Duraphat 5000ppm Fluoride Toothpaste (51g) listed above are missing information relating to the presence of allergens in the product.

MHRA drug alert date: 7th September 2023

MHRA drug alert link:  https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-colgate-palmolive-uk-limited-duraphat-5000ppm-fluoride-toothpaste-51g-el-23-a-slash-35?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=7848a41d-b926-4139-bb7e-b58e1fd3c5e9&utm_content=immediately

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

Further Information

For medical information enquiries or stock control enquiries please contact Colgate-Palmolive (UK) Limited on 00800 321 321 32 or https://www.colgatepalmolive.co.uk/contact-us

Class 3 recall-Evorel Sequi patches

Theramex has informed the MHRA that some cartons of Evorel Sequi contain the incorrect combination of patches. An error at the packaging site means that a limited number of packs have the incorrect combination of Evorel 50 and Evorel Conti patches

MHRA Drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-theramex-hq-uk-ltd-evorel-sequi-el-23-a-slash-34?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=42c6c82f-519c-4889-8d06-cdcb1e60c8c6&utm_content=immediately#contents

Further Information

For medical information enquiries please contact the Theramex Medical Information Department on 033 3009 6795 or via email: medinfo.uk@theramex.com

For pharmacy stock control enquiries please contact Alliance Customer Services Team on 020 3962 5555.

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 Caution in use- Tostran gel 2%

Kyowa Kirin Limited has notified MHRA that the priming instructions in the current PIL for Tostran 2% gel require updating.

Following a manufacturing change to the Tostran 2% gel dosage pump/dispenser system, the manufacturer has observed that the priming instruction requires changing. Data from the end of shelf life in-use testing has shown that the number of actuations required to prime the device to achieve correct dosing increases over time. This means that more pumps to prime the device being using it for the first time are now required. If these instructions are not followed then a less accurate first dose may be delivered. The Patient Information Leaflet and Summary Product Information will be updated to include these the new priming instructions, subject to approval by MHRA.

MHRA drug alert date: 31st August 2023

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-kyowa-kirin-limited-tostran-testosterone-2-percent-gel-el-23-a-slash-33

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

Further Information

For medical information enquiries please contact at medinfo@kyowakirin.com.

Tel: +44 (0)1896 664 000.

For stock control enquiries please contact customerqueries-uk@kyowakirin.com.

Tel: +44 (0) 7712 001288.

Class 2 recall-Epistatus 2.5mg Oromucosal Solution (pre-filled oral syringes)

Veriton Pharma Limited is recalling a specific batch of Epistatus (midazolam) 2.5mg Oromucosal Solution (pre-filled oral syringes) due to confirmed out of specification results related to the product appearance. Following a market complaint, the batch listed in this notification was investigated and it was confirmed that there is potential for some products to appear cloudy and/or contain crystalline particles. The Summary of Product Characteristics (SmPC) states that the product should be a ‘clear colourless to pale yellow solution.’ Additionally, there is specific information that states ‘do not use if the solution is not clear (e.g. cloudy or white particles are present).’

MHRA drug alert date: 30 August 2023

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-veriton-pharma-limited-epistatus-2-dot-5-mg-oromucosal-solution-pre-filled-syringe-pfs-el-23-a-slash-32?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=38dfbc19-9ce6-4702-b9fd-a2966b288eff&utm_content=immediately

Further Information

For medical information enquiries please contact Veriton Pharma Limited by emailing to centralmedicalinformation@veritonpharma.com or via the direct line: +44 (0)1932 690325. For stock control enquiries please contact Veriton Pharma Limited by emailing to orders@veritonpharma.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.

Class 4 Caution in use- Loceryl nail lacquer

Galderma (U.K.) Limited has informed the MHRA that a pallet of Loceryl 5% w/v Medicated Nail Lacquer from a batch licensed only for distribution in Ireland has been inadvertently placed into the UK supply chain due to a warehousing error at their UK pre-wholesaler. Although Loceryl is a registered medicine in both Ireland and the UK, there are differences between these products in the product labelling and Patient Information Leaflet (PIL) packaged with the medicine.

MHRA drug alert date: 29th August 2023

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-galderma-uk-limited-loceryl-5-percent-w-slash-v-medicated-nail-lacquer-5-dot-0-ml-el-23-a-slash-31?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=9a7e9437-f55e-4f24-82a6-d91ff2f6df4f&utm_content=immediately

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

Further Information

If you require more information, have further medical information enquiries (including replacement PIL enquiries) then please e-mail: medinfo.uk@galderma.com. For stock control queries, please contact: sales.uk@galderma.com

Class 2 Recall - Sodiofolin 50 mg/ml solution for injection/infusion

Medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to particles detected during long-term stability tests.

Further to EL(23)/A26 medac GmbH (t/a medac Pharma LLP) have identified further batches that are impacted. medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to particles detected during long-term stability tests. As stated in the Summary of Product Characteristics (SmPC): ‘Only clear solutions without visible particles should be used.’. These batches are being recalled as a precautionary measure and the root cause analysis investigation remains ongoing.

MHRA drug alert date: 21 August 2023

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-medac-gmbh-t-slash-a-medac-pharma-llp-sodiofolin-50-mg-slash-ml-solution-for-injection-slash-infusion-100mg-slash-2ml-vial-el-23-a-slash-28?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=57648150-86b0-4190-81bc-49b6880f578d&utm_content=immediately

Further Information

For all medical enquiries, please contact medical information at medac Pharma LLP by email to info@medacpharma.co.uk or by telephone 01786 458086.

Class 2 recall-Various Braun products

B. Braun Medical Limited is recalling various product batches as a precautionary measure after traces of midazolam were detected in the batches listed in this notification.

MHRA Drug alert link:https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-b-braun-medical-ltd-various-products-el-23-a-slash-27?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=d9a6644a-a63e-49c8-a1c5-8eb3269f9399&utm_content=immediately

Further Information

For stock control enquiries please contact via email or telephone: Josh Watts: Product Manager, email: josh.watts@bbraun.com or telephone: 07973 976257

For information about the recall please contact via email or telephone: Catherine Clulow: Local Vigilance and Project Coordinator, email: recalls.uk@bbraun.com or telephone: 0114 2259155

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.

Class 2 recall-Sodiofolin 50 mg/ml solution for injection/infusion

medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to particles detected during long-term stability tests.

MHRA drug alert date: 20th July 2023

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-medac-gmbh-t-slash-a-medac-pharma-llp-sodiofolin-50-mg-slash-ml-solution-for-injection-slash-infusion-400mg-slash-8ml-vial-el-23-a-slash-26?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=f7cf9bf8-abed-479c-8071-de26a4cdf913&utm_content=immediately

Further Information

For all medical enquiries, please contact medical information at medac Pharma LLP by email to info@medacpharma.co.uk or by 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.

Class 2 recall-Sabril Tablest & Sachets

Sanofi UK is recalling the listed batches of Sabril tablets and Sabril granules as a precautionary measure due to the detection of traces of tiapride in the batches of the source material of manufacturer for vigabatrin.

MHRA drug alert date: 13th July 2023

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-aventis-pharma-limited-t-slash-a-sanofi-sabril-500-mg-film-coated-tablets-and-sabril-500-mg-granules-for-oral-solution-el-23-a-slash-25?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=94be4cc6-3f3c-4a30-93a1-c5282da420d6&utm_content=immediately

Further Information

For stock control enquiries please contact GB-CustomerServices@sanofi.com or via telephone: 0800 854 430. For more information or medical information at uk-medicalinformation@sanofi.com or via telephone: 0800 035 25 25.

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.