Class 4 Caution in use- Concerta XL tablets 18 &36mg

Orifarm UK has informed the MHRA of an error with the Patient Information Leaflet (PIL) packaged within the parallel import packs of the specific batches of Concerta XL 18mg and 36mg prolonged release tablets mentioned in this notification.

MHRA drug alert date: 26th February 2024

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-orifarm-uk-ltd-concerta-xl-18mg-and-36-mg-prolonged-release-tablets-el-24-a-slash-07?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=a2016e58-88b6-4a8d-a1aa-ce9f9fa4bb23&utm_content=immediately

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

Further Information

For medical information and stock control queries please email jacook@Orifarm.com, or telephone 01923 204333.

Class 2 recall- Adakveo 10mg/ml

Novartis Pharmaceuticals UK Limited is recalling Adakveo 10 mg/ml concentrate for solution for infusion, batch number SJFN5, due to the benefit-risk balance of Adakveo no longer being considered favourable by the MHRA. This is because the Phase III study (STAND) of Adakveo in sickle cell disease patients with vaso-occlusive crises did not confirm its clinical benefit. As a consequence, the conditional marketing authorisation in the UK is being revoked.

MHRA drug alert date:21/02/24

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-novartis-pharmaceuticals-uk-limited-adakveo-10-mg-slash-ml-concentrate-for-solution-for-infusion-el-24-a-slash-06?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=5161cd08-b491-4965-a94e-03f1b56d8e4e&utm_content=immediately

Further Information

For medical information enquiries please contact Novartis Pharmaceuticals UK Limited at: https://www.novartis.com/uk-en/contact/contact-us, by email: medinfo.uk@novartis.com or via telephone: +44 1276 698370.

For stock control enquiries please contact: commercial.team@novartis.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 3 recall-Ramipril 1.25mg tabs

Torrent Pharma (UK) Limited is recalling certain batches of Ramipril 1.25mg tablets as a precautionary measure due to these batches having a low assay and high related substances test results after their release to the market.

MHRA Drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-torrent-pharma-uk-limited-ramipril-1-dot-25mg-tablets-el-24-a-slash-05?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=37e221c3-75aa-46d3-ad81-abb2683aab40&utm_content=immediately

Further Information

For medical information enquiries please contact APCER Life Sciences, via telephone: 0800 0885366, or email: Medinfo.Torrent@apcerls.com

For stock control enquiries please contact the Torrent Pharma (UK) Limited Customer Service & Sales Executive via telephone: 01293 574188,or email:  luke.davies@torrentpharma.co.uk  or priti.pragji@torrentpharma.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.

Class 4 caution in use-Gepretix 100mg capsules

Exeltis UK Limited has informed the MHRA regarding an inconsistency in the Patient Information Leaflet (PIL) packaged in cartons of the specified batches of Gepretix 100mg capsules.

MHRA drug alert date: 1st February 2024

MHRA drug alert link:  https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-exeltis-uk-limited-gepretix-100mg-capsules-el-24-a-slash-04#contents

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

Further Information

For medical information enquiries please contact Uk.medinfo@exeltis.com or telephone 01494411775.

For stock control enquiries please contact uk.office@exeltis.com

Class 4 caution in use- Pantoprazole 40mg Gastro resistant tablets

Crescent Pharma Limited has informed the MHRA regarding an error with the European Article Number (EAN) barcode on the cartons of the above-mentioned batches of Pantoprazole 40 mg Gastro-Resistant Tablets distributed by Crescent Pharma Limited.

MHRA drug alert date: 30th January 2024

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-cadila-pharmaceuticals-uk-limited-pantoprazole-40-mg-gastro-resistant-tablets-el-24-a-slash-03?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=65c56ca6-e713-4ca4-9ffd-014847ff9cd3&utm_content=immediately

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

Further Information

For medical information enquiries please contact pharmacovigilance-eu@cadilapharma.com or telephone: +44 1217901596

For stock control enquiries please contact info@crescentpharma.com or telephone: 01256 772730

Class 4 caution in use-Sugammadex 100 mg/ml solution for injection (2 ml vial)

USV UK Limited has informed the MHRA that Sugammadex 100 mg/ml solution for injection (2 ml vial), batch number 35000347, may contain some vials that contain a low volume of solution; less than the label claim of 2 ml.

MHRA drug alert date: 18th January 2024

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-usv-uk-limited-sugammadex-100-mg-slash-ml-solution-for-injection-2-ml-vial-el-24-a-slash-02?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=0b5575da-3811-4212-b5f0-7d8d33ce231e&utm_content=immediately

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

Further Information

For medical information enquiries please contact medical info at USV on medicalinfo@usvuk.com or phone: 00 800 89013370

For stock control enquiries please contact Novumgen on tapan.parmar@novumgen.uk or phone: 0203 096 6496 on extension 5 (Please note Novumgen is the first-line distributor of USV UK products in the UK).

Company led recall - NUTRAMIGEN 1 WITH LGG & NUTRAMIGEN 2 WITH LGG

Reckitt UK Health/Mead Johnson Nutrition have informed us of an issue regarding some batches of their product Reckitt UK Health/Mead Johnson Nutrition

Reason: “A voluntary product recall involving one (1) batch of Nutramigen LGG Stage 1 Hypoallergenic Infant Formula Power and two (2) batches of Nutramigen LGG Stage 2 Hypoallergenic Infant Formula Power (product details below). This action was taken due to a possibility of cross contamination with Cronobacter sakazakii. All product distributed went through extensive testing by Reckitt/Mead Johnson Nutrition and tested negative for the bacteria.”

Further Information

For medical information enquiries, please call +44 (0)1895 230575 or email ConsumerNutrition_GB@rb.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

Field Safety Notice- Viscopaste Bandage 4948 7.5CMX6M

We have received a Recall from EVOLAN PHARMA on VISCOPASTE BANDAGE 4948 7.5CMX6M

Date of recall: 21st December 2023

MHRA FSN Link: https://www.gov.uk/drug-device-alerts/field-safety-notices-fsns-from-18-to-22-december-2023

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 3 recall- Posaconazole Biocon 100mg Gastro-resistant Tablets

Biocon Pharma UK Limited are recalling a specific of batch Posaconazole 100mg Gastro-resistant Tablets due to an out of trend result for unspecified impurities during testing for stability.

MHRA Drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-biocon-pharma-uk-ltd-dot-posaconazole-biocon-100mg-gastro-resistant-tablets-el-23-a-slash-44

Further information

For product quality complaints and medical information enquiries contact PQCSMV@biocon.com. For reporting adverse events contact drugsafety.smv@biocon.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-Clobazam suspension 5mg/5ml & 10mg/5ml

Atnahs Pharma UK Ltd has informed the MHRA that the batches of Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension listed in this notification do not contain the most up to date safety information.

MHRA drug alert date: 13th December 2023

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-atnahs-pharma-uk-limited-clobazam-atnahs-5mg-slash-5ml-and-10mg-slash-5ml-oral-suspension-el-23-a-slash-43?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=d9cfeb7b-3172-4a81-9b19-60e910ea91a1&utm_content=immediately

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

Further Information

For more information, or medical information queries, please contact +44 (0) 1268 943 700, and for stock control queries, please contact +44 (0) 1268 943 700.