Class 4 Medicines Defect Information: ADVANZ Pharma Ltd, MacroBID 100mg Prolonged-Release Capsules

ADVANZ PHARMA has made the MHRA aware that certain batches of MacroBID 100mg Prolonged-Release Capsules have been packed with the incorrect Patient Information Leaflet (PIL).

MHRA drug alert date: 5th December 2022

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-advanz-pharma-macrobid-100mg-prolonged-release-capsules-el-22-a-slash-50?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=7dca1a8e-a797-4234-b6cb-7c92576fc0d0&utm_content=immediately

This is a caution in use only we are not accepting stock returns - if any defective stock is found it should be returned directly to the manufacturer.

Further information

For further information, medical enquiries, stock information or request for printed copy of the associated SmPC, please contact telephone: + 44 (0) 208 5889 131 or via email: medicalinformation@advanzpharma.com.

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Class 4 Medicines Defect Information: Lucis Pharma Ltd, Oxycodone Hydrochloride 10mg/ml oral solution

Lucis Pharma Ltd has informed the MHRA that there is a typographical error with text on the rear side of the outer packaging for Oxycodone Hydrochloride 10mg/ml Oral Solution.

MHRA drug alert date: 29 November 2022

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-lucis-pharma-ltd-oxycodone-hydrochloride-10mg-slash-ml-oral-solution-el-22-a-slash-49?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=1864253f-7b0a-4b30-9aad-78ec2edb6c19&utm_content=immediately

This is a caution in use only we are not accepting stock returns - if any defective stock is found it should be returned directly to the manufacturer.

Further information

For medical information and stock control queries please contact: enquiries@lucispharma.co.uk.

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Class 4 Medicines Defect Information: Martindale Pharma Venlafaxine 300mg XL Prolonged release tablets

Martindale Pharma has made the MHRA aware that the GTIN in the 2D barcode and the printed variable data represents the branded version of the product (Venlalic® XL 300 mg prolonged-release tablets).

MHRA drug alert date:  16 November 2022

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-macarthys-laboratories-t-slash-a-martindale-pharma-venlafaxine-xl-300-mg-prolonged-release-tablets-el-22-a-slash-47?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=499d8039-6eda-43fe-8884-9605b56b0d82&utm_content=immediately

This is a caution in use only we are not accepting stock returns - if any defective stock is found it should be returned directly to the manufacturer.

Further Information

For further information, medical enquiries and stock information, contact: Licensed@ethypharm.com

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Class 4 Medicines Defect Information: PRENOXAD 1MG/ML INJECTION

Macarthys Laboratories (trading as Martindale Pharma, an Ethypharm Group Company), has notified the MHRA of a limited number of Prenoxad packs in a batch marketed in France with missing needles.

MHRA drug alert date: 10th November 2022

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/national-patient-safety-alert-class-4-medicines-defect-information-prenoxad-1mg-slash-ml-solution-for-injection-macarthys-laboratories-aurum-pharmaceuticals-ltd-slash-ethypharm-group-due-to-potential-missing-needles-in-sealed-kits

This is a caution in use only we are not accepting stock returns - if any defective stock is found it should be returned directly to the manufacturer.

Further Information

For more information on licensed stock and resupply queries for the licensed presentation, please contact licensed@ethypharm.com; telephone number: 0800 028 7933.

For medical information queries and all other enquiries, please contact medinfo@ethypharm.com; telephone number 01277 266 600.

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Company Led Recall-Activa Thigh Length Open Toe Hosiery class 2 XL size

L&R medical have informed us that on the affected batch of Activa Thigh Length Open Toe Hosiery XL the product inside the packaging is Small and not Extra Large

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.

For more information please contact L&R MEDICAL UK LTD

customerservices@uk.lrmed.com

Quality&Regulatory@uk.lrmed.com

Class 3 Recall - Mebeverine hydrochloride 135mg Film-coated Tablets

Medreich Plc UK is recalling the above batch as a precautionary measure due to out of specification results for tablet dissolution during routine product release testing.

MHRA drug alert date: 27th October 2022

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-medreich-plc-mebeverine-hydrochloride-135mg-film-coated-tablets-el-22-a-slash-46?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=0b5b7f21-3a71-444e-be6b-ea061980a229&utm_content=immediately

Further Information

For more information or supply enquiries, please contact Medreich PLC at cs_team@medreich.co.uk or by phone at 0208 831 1580, 0208 831 1511 or 0208 831 1509

For medical information queries, please contact pharmacovigilance@medreich.com

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Class 4 Medicines Defect Information: Recordati Rare Diseases, Pedea 5 mg/ml solution for injection

Recordati Rare Diseases T/A Recordati Rare Diseases UK Ltd has made the MHRA aware that specific batches of Pedea 5 mg/ml solution for injection have been packaged with the incorrect Product Information Leaflet (PIL).

MHRA drug alert date: 25th October 2022

MHRA drug alert link: 

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-recordati-rare-diseases-pedea-5-mg-slash-ml-solution-for-injection-el-22-a-slash-45?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=8880eab9-9fb3-431a-85f0-7f29ba803bf5&utm_content=immediately

This is a caution in use only we are not accepting stock returns - if any defective stock is found it should be returned directly to the manufacturer.

For further information, including medical enquiries and stock information, please contact:

Recordati Rare Diseases UK Ltd (local representative, WDA(H): 15720) on Tel: +44 (0)1491 414333 or +33 1 47 73 64 58 or email: RRDmedinfo@recordati.com

Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to hospital pharmacists and pediatric doctors and nurses working in hospital setting for information.

CLASS 1 RECALL - TARGOCID 200MG POWDER FOR SOLUTION FOR INJECTION/INFUSION OR ORAL SOLUTION

Sanofi UK is initiating an urgent recall of the above batches of Targocid 200mg powder for solution for injection/infusion or oral solution.

This is due to out of specification results obtained for bacterial endotoxins, which has been confirmed through testing of retain samples. This issue was observed following a medical adverse event, which reported that four patients experienced high grade of fever approximately three hours post-administration of vials from the impacted batches.

Due to the out of specification results observed there is a potential life threatening or serious risk to patient health.

MHRA drug alert date: 21st October 2022

MHRA drug alert link: 

https://www.gov.uk/drug-device-alerts/national-patient-safety-alert-class-1-medicines-recall-notification-recall-of-targocid-200mg-powder-for-solution-for-injection-slash-infusion-or-oral-solution-aventis-pharma-limited-t-slash-a-sanofi-due-to-the-presence-of-bacteria?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=e7cf2b1f-d939-4835-991d-d771d9d5fe1b&utm_content=immediately

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

Further information

For more information on licensed stock and resupply queries for the licensed presentation, please contact GB-CustomerServices@sanofi.com; phone number: 0800 854 430.

For medical information queries and all other enquiries, please contact uk-medicalinformation@sanofi.com; phone number: 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.

CLASS 2 RECALL - EPHEDRINE HYDROCHLORIDE 30MG/ML SOLUTION FOR INJECTION

hameln pharma ltd is initiating a recall of the affected batches of Ephedrine Hydrochloride 30 mg/ml Solution for Injection as a precautionary measure.

MHRA drug alert date: 20 October 2022

MHRA drug alert link:  https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-hameln-pharma-ltd-ephedrine-hydrochloride-30-mg-slash-ml-solution-for-injection-el-22-a-slash-44?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=4eaf7378-a167-4795-8f45-fc22c803cc75&utm_content=immediately

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

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.

Company Led Recall - Endwarts freeze 7.5g

Viatris have informed that product Endwarts Freeze^® has been manufactured with 5 tips instead of the stipulated 7 as indicated on the packaging and leaflet.

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.

For more information please contact VIATRIS UK HEALTHCARE

Gary Marshall Gary.marshall@viatris.com 07817 486960