Class 4 Caution in use- Beconase Hayfever Nasal Spray 180 Dose (P)

Omega Pharma Ltd has identified that there is text missing in Section 2 of the Patient Information Leaflet (PIL) in packs of Beconase Hayfever Nasal Spray (P).

MHRA drug alert date: 26th April 2023

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-omega-pharma-ltd-beconase-hayfever-nasal-spray-el-23-a-slash-15?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=bcaed696-a02b-4ec1-bbed-8bd2b462dab8&utm_content=immediately

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

Further Information

For medical information, stock control queries and Patient Information Leaflet (PIL) requests, please contact: UKLOcustomerservice@perrigo.com

Class 4 Caution in use- Co-amoxiclav 125/31.25mg/5ml, 250/62.5mg/5ml powder for oral suspension

Sandoz limited has informed the MHRA that the products mentioned in this notification are not sugar free despite the carton stating ‘sugar free’. The ‘sugar free’ text was added to the carton in December 2008 in error.

MHRA drug alert date: 20th April 2023

MHRA drug alert link:  https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-sandoz-limited-co-amoxiclav-125-slash-31-dot-25mg-slash-5ml-250-slash-62-dot-5mg-slash-5ml-powder-for-oral-suspension-el-23-a-slash-14?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=8bedc9fd-dd67-44c7-8691-89546eb2ed97&utm_content=immediately#contents

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

Further Information

For more information, 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

Class 4 Caution in use- Briviact 75mg & 100mg film coated tablets

Ethigen Limited have informed the MHRA that the Patient Information Leaflet (PIL) in Briviact 75mg and Briviact 100mg film coated tablets contains incorrect or missing information.

MHRA drug alert date: 30th March 2023

MHRA drug alert link:  https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-ethigen-limited-briviact-75mg-and-100mg-film-coated-tablets-el-23-a-slash-13?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=029a9973-e8e8-4dc1-99ae-a45b0b7f8b12&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 contact the Regulatory Affairs Department at regulatory@ethigen.co.uk.

Class 2 recall-GONAPEPTYL Depot 3.75mg

Reason: “Ferring Pharmaceuticals Limited is recalling certain batches of GONAPEPTYL Depot 3.75mg due to a defect noticed in the seal of the needle wrapping for the CE-marked 30-millimeter (30mm) needle for subcutaneous injection that is supplied with each product pack.”

MHRA drug alert date  23rd March 2023

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-ferring-pharmaceuticals-limited-gonapeptyl-depot-3-dot-75mg-powder-and-solvent-for-suspension-for-injection-el-23-a-slash-12

• MHRA ref: MDR 065-03/23

Further Information

For all medical enquiries, please contact medical information: medical.uk@ferring.com.

For supply queries, please contact customer services: customer.services@ferring.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 - Sildenafil 10mg/ml Oral Suspension

CLASS 3 RECALL -  SILDENAFIL 10MG/ML ORAL SUSPENSION

Rosemont Pharmaceuticals Limited has informed the MHRA that the Press In Bottle Adaptor (PIBA) supplied with the pack (carton) in the batch listed above is too wide to fit the neck of the medicine.

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-rosemont-pharmaceuticals-limited-sildenafil-10mg-slash-ml-oral-suspension-el-23-a-slash-11?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=7d86bb08-f180-4501-855c-2a3380963267&utm_content=immediately

For more information, medical information queries or replacement PIBA enquiries, please contact: pharmacovigilance@rosemontpharma.com.

For stock control queries, please contact: customerservices@rosemontpharma.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- Venlafaxine 150, 225 and 300mg XL tablets-Martindale brand

Additional to the batches included in the previous Class 4 Medicines Notification (reference EL(22)A/47), 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 prolonged-release tablets).

MHRA drug alert date: 16th March 2023

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-150mg-225mg-300mg-prolonged-release-tablets-el-23-a-slash-10?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=466f420a-5cf3-4fcc-8f9d-043cf1141af8&utm_content=immediately

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

Further Information

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

Class 2 recall- All Pholcodine containing products

Reason: Following the conclusion of a review of post-marketing safety data by the MHRA, all pholcodine-containing medicines are being recalled and withdrawn from the UK as a precaution.

MHRA drug alert date: 14/03/23

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-various-marketing-authorisation-holders-pholcodine-containing-products-el-23-a-slash-09?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=61c43c8f-6aa7-4d2a-a81b-73bece5741ba&utm_content=immediately#brief-description-of-the-problem

MHRA ref: MDR 008-12/22

Further Information

For more information or, medical enquiries, please contact the respective companies below:

The Boots Company PLC

Boots Customer Care:

Telephone: 0345 0708090

Thornton & Ross Limited / LCM Limited

Telephone: 01484 848164

Email: thorntonross@medinfomation.co.uk

Bell Sons & Company (Druggists) Limited

Qualified Person for Pharmacovigilance (QPPV): Mr Trevor Price:

Telephone: 0151 422 1216 / mobile: 07739 327 095

Email: trevor.price@bells-healthcare.com

Pinewood Laboratories Limited

Drug Safety & Information department, Wockhardt UK Limited:

Email: drug.safety@wockhardt.co.uk

Telephone: 01978 661261

Glaxosmithkline Consumer Healthcare (UK) Trading Limited

Contact Haleon consumer services:

Telephone: 0800 783 8881

Email: mystory.gb@haleon.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.

company-led recall: Sylk vaginal lubricant

Sylk ltd has informed us Mould has been reported in some of the retail bottles. The affected batches were distributed to retailers in the United Kingdom from mid-2022 onwards

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- Clexane 10,000 IU (100mg) / 1ml Syringes

Drugsrus Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in specific batches of Clexane 10,000IU (100mg)/1 ml Syringes contains a typographical error in the leaflet.

MHRA drug alert date: 9th March 2023

MHRA drug alert link:  https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-drugsrus-limited-clexane-10000-iu-100mg-slash-1ml-syringes-el-23-a-slash-08

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

Further Information

For more information, medical information queries or replacement PIL enquiries, please contact: recall@drugsrus.co.uk or 020 8423 3800. For stock control queries, please contact: info@drugsrus.co.uk or 020 8423 3800

Class 4 Caution in use- Methadone 1mg/mL Oral Solution BP Sugar Free and Methadone Mixture 1mg/ml

Thornton & Ross Ltd has informed the MHRA that specific batches of Methadone 1mg/mL Oral Solution BP Sugar Free and Methadone Mixture 1mg/ml, have been packaged with the incorrect Product Information Leaflet (PIL)

MHRA drug alert date: 7th March 2023

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-thornton-and-ross-ltd-methadone-1mg-slash-ml-oral-solution-bp-sugar-free-methadone-mixture-1mg-slash-ml-el-23-a-slash-07?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=5ef47bfe-e5f4-4643-8952-9a5fd54ed360&utm_content=immediately

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

Further Information

For medical information queries please contact thorntonross@medinformation.co.uk. Upon request, Thornton & Ross Ltd will provide hard copies of the updated PIL to pharmacy teams.