Class 4 Caution in use- Buccolam 10mg

Orifarm UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in one batch of Buccolam 10mg Oromucosal solution has missing information regarding having to break the seal on the inner container before use.

MHRA drug alert date: 22nd May 2023

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-orifarm-uk-ltd-buccolam-10mg-oromucosal-solution-el-23-a-slash-18?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=d06c9595-2c98-4c18-90d1-5b738d6dc70d&utm_content=immediately

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

Further Information

For more information, medical or supply enquiries, please contact 01276 698370, or email uk_enquiries@orifarm.com

Class 4 Caution in use- Simulect 10mg & 20mg powder and solvent for Solution for injection or infusion

Novartis Pharmaceuticals has informed the MHRA that the solvent (water for injections in ampoules) co-packed with the impacted batches of Simulect powder for injection, may contain glass fragments approximately 20 – 800 µm in size.

MHRA drug alert date: 16th May 2023

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-novartis-pharmaceuticals-simulect-10mg-and-20mg-powder-and-solvent-for-solution-for-injection-or-infusion-el-23-a-slash-17?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=d08ff9e2-3185-4fca-b71c-1083f3f9bff0&utm_content=immediately

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

Further Information

For more information, medical or supply enquiries, please contact 01276 698370, or email medinfo.uk@novartis.com

class 3 recall- Gemcitabine 1g/26.3ml & 2g/52.6ml Solution For Infusion Vial

Hikma Farmacêutica Portugal S.A has informed the MHRA of a potential issue impacting the batches listed in this notification.

MHRA Drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-hikma-farmaceutica-portugal-s-dot-a-gemcitabine-1g-slash-26-dot-3ml-and-2g-slash-52-dot-6ml-solution-for-infusion-vial-el-23-a-slash-16

For more information or medical information queries, please contact: Portugalcomplaints@hikma.com or Portugaleupharmacovigilance@hikma.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 1 recall-Emerade 300 & 500 Auto-Injectors

reason: Pharmaswiss Česka republika s.r.o. and distributor Bausch & Lomb UK Limited is recalling all unexpired batches of Emerade 500 micrograms and Emerade 300 micrograms adrenaline auto-injectors (also referred to as pens) from patients. This is due to an issue identified during an ISO 11608 Design Assessment study where some auto-injectors failed to deliver the product or activated prematurely

MHRA drug alert date  9th May 2023

MHRA ref: MDR 020-05/23

Further Information

For stock enquiries, please contact Bausch & Lomb Customer Services:

Tel: 020 8781 2991

Email: Pharma_CS@bausch.com

For medical information enquiries please contact the Medical Information Team:

Email: medinfo.europe@bauschhealth.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: Beambridge 33025 leg bag Short Tube

Beambridge Medical Ltd have informed us that some bags in the affected batch are prone to leaking

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- 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.