Class 2 recall-Lercanidipine HCl 20mg Tablets

We have received a Class 2 Recall from Recordati Industria Chimica e Farmaceutica S.p.A. on Lercanidipine HCl 20mg Tablets.

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-lercanidipine-hcl-20mg-tablets-recordati-industria-el-25-a-slash-17?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=070d68eb-f056-4249-95fe-9701644771a1&utm_content=immediately

DMRC Ref: 35334038

Reason: “Recordati Pharmaceuticals Limited has informed the MHRA of an error in the strength of the product printed on some of the faces (sides) of the product carton. The error is limited to one batch of Lercanidipine HCl 20mg Tablets. The packs are incorrectly labelled as 10mg on some sides of the product carton when they are 20mg tablets.”

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 medinfo@recordati.co.uk, or telephone +353 (0)87 6245669. For stock control enquiries please email customerservice@recordati.com, or telephone 01491 576 336.

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 (17/04/2025), cannot be reimbursed by way of a credit.

Class 2 recall-Synalar 30g & 60g gel

It has been identified that the batches of Synalar Gel 30g and 60g listed in this notification contain a residual solvent (benzene) at a level exceeding the ICH limit of 2ppm. Reig Jofre UK are recalling the batches as a precautionary measure. This recall is at the pharmacy and wholesaler level.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-synalar-gel-30g-synalar-gel-60g-fluocinoline-acetonide-0-dot-025-percent-reig-jofre-uk-el-25-a-slash-16?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=6cd7db97-6cc0-4a89-b429-009bf1866ec6&utm_content=immediately

MHRA ref:DMRC-35165402

Further Information

For medical information enquiries please contact Reig Jofre UK Medical Information on 0330 1359 434 or by email MedInfoUK@reigjofre.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 4 caution in use-Renacet 465 & 950 mg tablets

RenaCare NephroMed GmbH has informed the MHRA of the presence of an undeclared excipient in the coating of the tablets. This excipient is Macrogol 6000, which has always been included in Renacet Tablets but has been omitted from the list of excipients in error.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-renacet-475-mg-and-950-mg-tablets-calcium-acetate-renacare-nephromed-gmbh-el-25-a15?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=23366ae3-59e2-40b3-aa14-5d94fd8c2381&utm_content=immediately

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

Further Information

For medical information enquiries please telephone 01159 124 253 or email medinfo@stanningleypharma.co.uk

For stock control enquiries telephone 01159 124 253 or email medinfo@stanningleypharma.co.uk

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.