Class 4 caution in use- Baclofen 10mg Tablets, Special Concept Development UK Limited

Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for the batches listed in this notification do not contain the correct safety information.

MHRA drug alert Date: 27/11/25

MHRA drug alert link:Class 4 Medicines Defect Notification: Special Concept Development UK Limited, Baclofen 10mg Tablets, EL(25)A/51 - GOV.UK

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

further information

For medical information enquiries please email medinfo@rxfarma.co.uk or telephone 08003580163.

For supply chain inquiries please contact email supplychain@rxfarma.co.uk or telephone 01923 332 777.

Class 4 Caution in use-Moclobemide 150mg tablets

Lexon UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification is missing important updated safety information.

MHRA drug alert Date: 25/11/25

MHRA drug alert link: Class 4 Medicines Defect Notification: Lexon UK Ltd, Moclobemide 150mg tablets, EL(25)A/50 - GOV.UK

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

further information

For all medical information enquiries and information on this product, please email QA@lexonuk.com, or telephone 01527 505 414. For stock control enquiries please email QA@lexonuk.com, or telephone 01527 505 414.

Class 3 recall- Fingolimod SUN 0.5mg hard capsules

CLASS 3 RECALL

Class 3 Recall from Sun Pharmaceutical Industries Limited

on Fingolimod SUN 0.5mg hard capsules

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-sun-pharmaceutical-industries-limited-fingolimod-sun-0-dot-5mg-hard-capsules-el-25-a-slash-49?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=43ceb057-770e-45c5-b999-ad92df38ac1a&utm_content=immediately

MHRA ref: PL 31750/017

Reason: “Sun Pharma UK Limited is conducting a precautionary recall of a single batch of Fingolimod SUN 0.5 mg hard capsules due to reports of capsule breakage on removing from the blister. No other batches of Fingolimod SUN 0.5mg hard capsules are impacted.”

Please can you ensure that your stores quarantine the product listed below.

Further Information

For all medical information enquiries and information on this product, please email Cserv.uk@sunpharma.com, or telephone 020 8848 5050 / 07974754551.

For stock control enquiries please email Cserv.uk@sunpharma.com, or telephone 020 8848 5050.

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-Atorvastatin 20mg and 80mg Film-coated Tablet

Sun Pharma UK Limited are recalling the batches of tablets specified in the table as a precautionary measure due to failing dissolution test results reported during ongoing stability studies.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-sun-pharmaceutical-industries-limited-atorvastatin-20mg-and-80mg-film-coated-tablets-el-25-a-slash-48?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=99643300-1345-488a-afc4-eb384dcbc1d6&utm_content=immediately

MHRA drug alert date 11/11/25

Further Information

For all medical information enquiries and information on this product, please email Cserv.uk@sunpharma.com, or telephone 020 8848 5050 / 07974754551.

For stock control enquiries please email Cserv.uk@sunpharma.com, or telephone 020 8848 5050.

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-Emylif 50mg orodispersible film

Zambon SpA is recalling an affected batch as a precautionary measure due to out of specification results for unknown impurities during ongoing stability testing.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-zambon-spa-emylif-50mg-orodispersible-film-el-25-a-slash-47

MHRA drug alert date 10/11/25

Further Information

For all medical information enquiries and information on this product, please email infoUK@zambongroup.com, or telephone + 44 (0)800 0288 942.

For stock control enquiries please email infoUK@zambongroup.com, or telephone + 44 (0)800 0288 942.

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- Compound Sodium Lactate Solution for Infusion BP (Hartmann's Solution for infusion) in Viaflo 1000ml

Baxter Healthcare is recalling one batch of Compound Sodium Lactate (Hartmann’s Solution) 1000mL. This is due to a packaging error where some cartons labelled as Hartmann’s Solution may contain Ringer’s Solution 1000mL.

MHRA drug alert linkhttps://www.gov.uk/drug-device-alerts/class-2-medicines-recall-baxter-healthcare-limited-compound-sodium-lactate-solution-for-infusion-bp-hartmanns-solution-for-infusion-in-viaflo-1000ml-el-25-a-slash-46?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=4134130c-5221-48d2-8fe8-bc296bb64f23&utm_content=immediately

MHRA drug alert date 28/10/25

Further Information

For all medical information enquiries and information on this product, please email Medinfo_UKI@baxter.com, or telephone 0800 0260514. 

For stock control enquiries please email victoria_franklin@baxter.com, or telephone +44 07825 374866. 

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 Ipratropium Bromide 500 microgram / 2ml Nebuliser Solution

Accord Healthcare Ltd is recalling a batch of Ipratropium Bromide 500 microgram/2ml Nebuliser Solution after a foil pouch was found to contain ampoules with incorrect labels intended for the Korean market

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-accord-healthcare-ltd-ipratropium-bromide-500-microgram-slash-2ml-nebuliser-solution-el-25-a-slash-45?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=3205dad9-9795-48a8-bfca-a50aae5041c2&utm_content=immediately

MHRA drug alert date 23/10/25

Further Information

For all medical information enquiries and information on this product, please email Accord-UK Medical Information Department medinfo@accord-healthcare.com, or telephone 01271 385257.

For stock control enquiries please email Accord-UK Customer Services Team customerservices@accord-healthcare.com, or telephone 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.

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- Relonchem Ltd, Various Products

Relonchem Ltd has informed the MHRA that duplicate GTIN numbers have been assigned to certain Losartan potassium/Hydrochlorothiazide coated tablets in error and a duplicate EAN number has been assigned to certain Risperidone tablets in error.

MHRA drug alert date 23/10/25

MHRA drug alert link: Class 4 Medicines Defect Notification: Relonchem Ltd, Various Products, EL(25)A/44 - GOV.UK

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

Further Information

For all medical information enquiries and information on this product, please email medicalinformation@relonchem.com, or telephone 0151 556 1860.

For stock control enquiries please email medicalinformation@relonchem.com, or telephone 0151 556 1860.

Class 4 caution in use- Gemcitabine 2g/52.6ml concentrate for solution for infusion

Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions.

MHRA drug alert Date: 04/09/25

MHRA drug alert link: Class 4 Medicines Defect Notification: Hikma Farmacêutica, Gemcitabine 2g/52.6ml concentrate for solution for infusion, EL(25)A/43 - GOV.UK

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

further information

For medical information queries please telephone +351 21 960 8410, or email portugaleupharmacovigilance@hikma.com.

For all stock control enquiries please telephone +44 020 7399 2760, or email customerserviceuk@hikma.com

Field Safety notice- Medihoney products

Packaging failures were identified related to the MediHoney® Wound and Burn products

Date of recall 02/09/25

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.

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.