Class 4 caution in use-Risperidone 1mg, 2mg & 3mg tablets

Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Risperidone 1mg, 2mg and 3mg and Tablets.

MHRA Drug alert date: 26th September 2024

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-sandoz-ltd-dot-risperidone-1mg-2mg-3mg-tablets-el-24-a-slash-43?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=b4d60715-056e-4313-977a-7a57a225af0e&utm_content=immediately

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

Further Information

For medical information queries, please contact: sandozgb@EU.propharmagroup.com, Telephone: +44 1276 698 101.

For stock control queries, please contact: sales.sandoz-gb@sandoz.com, Telephone: +44 1276 698607.

Field safety notice-Lacri-lube eye ointment

We have received a field safety notice from Abbvie Ltd on two batches of Lacri-lube

Date of recall:19/09/24

Reason: The impacted lots may contain a breach in the tube seal

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-Eldepryl 5mg tabs

Orion Pharma (UK) Ltd is recalling this batch as a precautionary measure due to an out of specification result in the assay result during the follow up stability study of the batch.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-orion-pharma-uk-ltd-eldepryl-5mg-tablets-selegiline-el-24-a-slash-42?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=0458c22f-f91b-4964-94a8-801ea7ca1fbe&utm_content=immediately

Further Information

For medical information enquiries please email UK.MedicalInformation@orionpharma.com, or telephone 01635 520300.

For stock control enquiries please email orionukar&customerservices@orionpharma.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.

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-24-a-slash-41?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=07ebe937-6424-4864-9e95-99798efa4de8&utm_content=immediate

Further Information

For medical information enquiries please contact the Theramex Medical Information Department via medinfo.uk@theramex.com or call 0333 009 6795.

For stock control enquiries please contact Alliance Customer Services Team on 0330 100 0448.

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 - Ponstan 250mg Capsules & Ponstan Forte 500mg Tablets

CLASS 4 CAUTION IN USE - Ponstan 250mg Capsules & Ponstan Forte 500mg Tablets

Chemidex pharma ltd has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batches listed in the tables above for Ponstan 250mg capsules and Ponstan Forte 500mg tablets include an out of date PIL, dated March 2020 and January 2021 respectively. The latest PIL, authorised in February 2023 includes updated information related to the use of the product during pregnancy, which is not mentioned in the out of date PILs.” 

MHRA Drug alert date: 27th August 2024

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-chemidex-pharma-ltd-ponstan-250mg-capsules-and-500mg-tablets-mefenamic-acid-el-24-a-slash-40?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=971b62a0-6294-430f-8887-9e276c779eb6&utm_content=immediately

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

Further Information

For medical information enquiries please email essentialpharmaUK@EU.ProPharmaGroup.com , or telephone +44 (0)1423 850700.

For stock control enquiries please email commercial@essentialpharmagroup.com.

Class 3 Recall - FINGOLIMOD CAP 0.5MG Active

Class 3 Recall - FINGOLIMOD CAP 0.5MG

Glenmark Pharmaceuticals Europe Ltd is recalling the above batches after retesting showed out of specification results. The tabled batches are being recalled as a precautionary measure after testing showed variability of the capsule contents beyond permitted levels 

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-glenmark-pharmaceuticals-europe-ltd-fingolimod-0-dot-5-mg-hard-capsules-el-24-a-slash-39?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=84383e4c-1c50-4c97-be85-13a3b91a3aa1&utm_content=immediately

Further Information For medical information enquiries please use the following options: by phone +44 8004 580 383 or email medical_information@glenmarkpharma.com

For medical information enquiries please email dl-drugsafety@strides.com and DL-GPV-Group@arcolab.com or telephone 01923 255580.

For stock control enquiries please email orders.uk@glenmarkpharma.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.

Class 2 recall-Loperamide 2mg capsules

Strides Pharma UK Ltd is recalling the listed batch as a precautionary measure due to an out of specification result for microbial contamination, reported during retesting.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-strides-pharma-uk-limited-loperamide-hydrochloride-capsules-2mg-el-24-a-slash-38?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=44984f16-794e-4463-a959-7a87d62a9764&utm_content=immediately

Further Information

For medical information enquiries please email dl-drugsafety@strides.com and DL-GPV-Group@arcolab.com or telephone 01923 255580.

For stock control enquiries please email customerservicesuk@stridespharma.co.uk or telephone 01923 255580.

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-Trazodone Hydrochloride 50mg, 100mg Capsules & 50mg/5ml Oral Solution

Dawa Limited has informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Trazodone Hydrochloride 50mg and 100mg Capsules and Trazodone Hydrochloride 50mg/5ml Oral Solution.

MHRA Drug alert date: 14th August 2024

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-dawa-limited-trazodone-hydrochloride-50mg-100mg-capsules-and-50mg-slash-5ml-oral-solution-el-24-a-slash-37?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=a3c9727d-c8ba-4e0d-a555-486c62c02c7c&utm_content=immediately

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

Further Information

For medical information enquiries please contact the distributor, Drugsrus Limited on 0208 423 3800, info@drugsrus.co.uk.

For stock control enquiries please contact the distributor, Drugsrus Limited on 0208 423 3800, info@drugsrus.co.uk.

Class 4 caution in use-PI Diflucan Oral Suspension 40mg/ml

Star Pharmaceuticals Limited has informed the MHRA that an error has been identified in the Patient Information Leaflet (PIL) for two batches of Diflucan Oral Suspension 40mg/ml.

MHRA Drug alert date: 12th August 2024

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-4-medicines-notification-star-pharmaceuticals-limited-diflucan-oral-suspension-40mg-slash-ml-el-24-a36?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=ecc06db3-7c2a-4ca9-9340-a1d2de6ee506&utm_content=immediately

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

Further Information

For medical information enquiries please contact the distributor, Drugsrus Limited on 0208 423 3800, info@drugsrus.co.uk.

For stock control enquiries please contact the distributor, Drugsrus Limited on 0208 423 3800, info@drugsrus.co.uk.

Class 3 recall-Trandolapril 0.5mg, 2mg, 4mg Capsules

Accord-UK Ltd is recalling the listed batches after retesting showed out of specification results.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-accord-uk-ltd-trandolapril-0-dot-5mg-2mg-4mg-capsules-el-24-a-slash-35?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=275180ae-fe38-4fd7-b2a3-a0b0bdcfdf24&utm_content=immediately

Further Information

For medical information enquiries please contact Accord-UK Ltd Medical Information Department on 01271 385257

For stock control enquiries please contact Accord- UK Ltd Customer Services Team on 0800 373573.

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.