Class 3 recall-Urospir 50mg/5ml solution

Rosemont Pharmaceuticals Limited is recalling a single batch of Urospir 50mg/5ml Oral Solution (spironolactone) as a precautionary measure. The recall is due to errors in some of the dose calculation in millilitres being stated incorrectly in the SmPC and PIL.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-urospir-50mg-slash-5ml-oral-solution-el-25-a-slash-14?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=9691ad0b-c6c7-495b-b16f-dd6e46fd62a0&utm_content=immediately

MHRA ref: DMRC-35150350

Further Information

For all medical information enquiries and information on this product, please contact pharmacovigilance@rosemontpharma.com, or telephone 0113 244 1400. For stock control enquiries please contact customerservices@rosemontpharma.com, or telephone 0113 244 1999.

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-PI Utrogestan 200mg capsules

Uni Health Distribution Ltd has informed the MHRA of a typographical error on the approved carton overlabel for certain batches of Utrogestan Vaginal 200 mg Capsules. The carton label references ‘micrograms’ where it should actually state ‘milligrams’.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-utrogestan-vaginal-200-mg-capsules-progesterone-el-25-a-slash-13?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=e74c1d0f-d431-4333-a97c-c6a1841f0ae1&utm_content=immediately

MHRA ref:DMRC-35159465

Further Information

For further information and all enquiries please contact info@uhdltd.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.

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-PI sirdupla 25/250mcg

Cross Healthcare Limited have informed the MHRA that there is a printing defect on the outer labels for the Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension, batch 77518.

MHRA Drug alert date: 31st March 2025

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-sirdupla-25-microgram-slash-250-microgram-per-metered-dose-pressurised-inhalation-suspension-el-25-a-slash-12?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=d22cb799-f4af-4d08-9ede-bec4f9f733fa&utm_content=immediately

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

Further Information

For further information please email gary@crosshealthcare.co.uk or telephone 01786 817707.

Class 4 caution in use-Azithromycin 250mg capsules

Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in the table include an outdated PIL. These packs contain a PIL which was revised in October 2021. The latest approved PIL is dated February 2025.

MHRA Drug alert date: 11th March 2025

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-azithromycin-250-mg-capsules-el-25-a-slash-11?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=58be95dd-6279-417b-8a53-1c58d583648b&utm_content=immediately

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

Further Information

For medical information enquiries please email safety.uk@lambda-cro.com or telephone 0080089013370

For stock control enquiries please email JPUK.Customerservice@jubl.com , or telephone 01233 552293

Class 2 recall-Boots Paracetamol tablets 500mg 16s

Aspar Pharmaceuticals Limited have informed the MHRA of an error related to a batch of Boots Paracetamol 500 mg tablets (16s). The foil blister inside the carton incorrectly states ‘Aspirin 300 mg Dispersible Tablets’. The tablets are confirmed to be Paracetamol 500 mg table

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-boots-paracetamol-500-mg-tablets-16s-el-25-a-slash-10?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=f8e9956d-315e-40fa-a334-d4f2a6ef648c&utm_content=immediately

Further Information

For stock control enquiries please contact Aspar Pharmaceuticals Limited Info@aspar.co.uk or telephone 02082059846.

For any additional enquiries to Aspar Pharmaceuticals Limited please email Uma.cherukuri@aspar.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.

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-Pemetrexed infusion bag 800mg & 1000mg Sun Pharma

Sun Pharmaceutical Industries Europe B.V. is recalling those product batches listed in this notification as a precautionary measure due to out of specification results reported for the Particulate Matter Test (PMT) during stability testing.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-sun-pharmaceutical-industries-europe-b-dot-v-pemetrexed-1000mg-slash-100ml-10mg-slash-ml-and-800mg-slash-ml-8mg-slash-ml-infusion-bag-el-25-a-slash-09?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=46a9a60c-085d-4255-ad01-adb0b60db794&utm_content=immediately

Further Information

For stock control enquiries please contact Customer Service UK Cserv.uk@sunpharma.com or phone (0) 20 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-PI Glucophage 500, 750 and 1000mg

All batches of the named products are being recalled by the Marketing Authorisation Holder in Italy and subsequent UK parallel distributor companies as a precautionary measure due to the product being manufactured with the incorrect grade of an excipient.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-glucophage-sr-500-mg-750mg-and-1000mg-prolonged-release-tablets-el-25-a-slash-07?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=298bffdc-cf0f-4149-9784-b8eb50d1064a&utm_content=immediately

MHRA ref: DMRC-34710077

Further Information

• For PilsCo Ltd. stock control enquiries please contact pmccourt@ethigen.co.uk
• For Uni Health Distribution (Savio Industrial S.r.L.or Special Product’s Line SpA) stock control enquiries please contact info@uhdltd.co.uk
• For Star Pharmaceuticals Limited stock control and recall enquiries please contact recall@drugsrus.co.uk
• For B&S Quality group and Customer Service enquiries please contact qa@bnshealthcare.com & customerservices@bnsdistribution.uk
• For Quadrant Pharmaceuticals stock control and recall enquiries please contact Angeline.Rees@Maxearn.co.uk

For further medical information enquiries please contact: info@bruno.org

Please return all affected stock to your original supplier for credit.

Unfortunately, we can only accept stock purchased from us (Alliance Healthcare Distribution Limited).

Please note that anything not returned to us, or notified to us, within 12 weeks of this notification, cannot be reimbursed by way of a credit.

Class 4 caution in use-Lansoprazole 15mg hard caps Teva

Teva UK Limited is reporting a minor typographical error on the carton for Lansoprazole Gastro-Resistant Hard Capsules 15mg. There are two instances where the dosage form is stated as “tablets” where it should state “gastro-resistant capsule, hard”.

MHRA Drug alert date: 11th February 2025

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-4-medicines-notification-lansoprazole-gastro-resistant-hard-capsules-15mg-el-25-a-slash-06?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=0d2bb3ae-b928-4794-a36a-408d0f4fb540&utm_content=immediately

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

Further Information

For medical information enquiries please telephone 0207 540 7117 or email medinfo@tevauk.com.

For stock control enquiries telephone 0800 590502 or email Customer.services@tevauk.com.

Class 2 recall- Nitrofurantoin 100 mg Prolonged-Release capsules

Class 2 recall- Nitrofurantoin 100 mg Prolonged-Release capsules

CNX Therapeutics is recalling the batches listed in this notification as a precautionary measure due to a small number of packs that contain an additional tablet of Nitrofurantoin. The registered product is a capsule containing powder and two yellow tablets.

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-nitrofurantoin-cnx-therapeutics-100-mg-prolonged-release-capsules-el-25-a-slash-05?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=1ea315d7-385a-456b-af14-f9e50bb7568c&utm_content=immediately

MHRA ref: DMRC-34425982

Further information

For medical information enquiries please contact 0207 821 2840 or medinfo@cnx-therapeutics.com

For stock control enquiries please contact 0207 821 2840 or supplychain@cnx-therapeutics.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).

Please note that anything not returned to us, or notified to us, within 12 weeks of this notification, cannot be reimbursed by way of a credit.

Class 2 recall-Amlodipine 2.5mg tablets Bristol

Bristol Laboratories Limited is recalling the batches specified in the table as a precautionary measure due to possible microbial contamination.

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-bristol-laboratories-limited-amlodipine-bristol-lab-2-dot-5-mg-tablets-el-25-a-slash-04?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=3a7e5e7f-ca74-4fe6-9005-c90bbe44a2d0&utm_content=immediately

Further information

For medical information enquiries please contact: Notifications@bristol-labs.co.uk

For stock control enquiries please contact: Notifications@bristol-labs.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).

Please note that anything not returned to us, or notified to us, within 12 weeks of this notification, cannot be reimbursed by way of a credit.