Class 2 recall-Zaditen eye drops

Laboratoires Théa trading as Thea Pharmaceuticals Limited have notified the MHRA of an out of specification event related to environmental monitoring during manufacturing, which may increase the risk of microbial contamination of the medicinal product.

Drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-zaditen-0-dot-25-mg-slash-ml-eye-drops-solution-laboratoires-thea-el-25-a-slash-34

drug alert date: 4/07/25

Further Information

For stock control enquiries please contact:

• For pharmacies supplied by a wholesaler, returns should be made via the wholesaler.
• For wholesalers, please contact Mawdsleys PreWholesaler (MPW) customer services using e-mail address customer.services@mpwpharma.co.uk
• For healthcare establishments: please arrange local destruction and make a claim through Mawdsleys PreWholesaler customer.services@mpwpharma.co.uk

For more information or medical information please call 0345 521 1290 (and select option 3) or e-mail thea-pharma@medinformation.co.uk

For stock control enquiries please email customer.services@mpwpharma.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-Simvastatin 10mg Tablet, Crescent Pharma Ltd

Crescent Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of a batch of simvastatin 10 mg Tablets distributed by Alliance Healthcare UK.

MHRA Drug alert link: Class 4 Medicines Defect Notification: Simvastatin 10mg Tablet, Crescent Pharma Ltd, EL(25)A/33 - GOV.UK

MHRA drug alert date: 3/07/25

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 medinfo@crescentpharma.com, for reporting of side effects email safety@crescentpharma.com or telephone +44 1217901596.

For stock control enquiries please email Sean.McCaul@alliance-healthcare.co.uk

Class 4 caution in use-Erythromycin Stearate BP 250mg Tablets

Amdipharm UK Ltd has informed MHRA that the Patient information leaflet (PIL) in the cartons for the batch listed in this notification includes a superseded PIL.

MHRA Drug alert link: Class 4 Medicines Defect Notification: Erythromycin Stearate BP 250mg Tablets, Amdipharm UK Ltd, EL(25)A/32 - GOV.UK

MHRA drug alert date: 1/07/25

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

Further Information

For medical information enquiries please email medicalinformation@advanzpharma.com, or telephone +44 (0) 208 588 9131

For stock control enquiries please email custcustomercare@advanzpharma.com or telephone 0208 588 9441

Class 3 recall-Tamoxifen 20mg Film-Coated Tablets

Wockhardt UK Limited is recalling a batch as a precautionary measure following the identification of a dissolution failure during stability testing.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-tamoxifen-20mg-film-coated-tablets-wockhardt-uk-ltd-el-25-a-slash-31?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=51a03b30-994a-4270-a2ee-77e56b55fcd8&utm_content=immediately

MHRA drug alert date: 30/06/25

Further Information

For medical information enquiries please email drug.safety@wockhardt.co.uk, or telephone 01978 661261 and ask for ‘drug safety’.

For stock control enquiries please email group_uk_csu@wockhardt.co.uk, or telephone 01978 661261and ask for ‘customer services’.

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 – Omeprazole 20 mg/15 ml Oral Solution Active

We have received a Class 3 Recall from Glenmark Pharmaceuticals on Omeprazole 20 mg/15 ml Oral Solution

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-omeprazole-20-mg-slash-15-ml-oral-solution-glenmark-pharmaceuticals-europe-ltd-el-25-a-slash-30?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=e78400fa-abcd-4b11-8293-0ab9b0eb4e68&utm_content=immediately

MHRA ref: DMRC-35139406

Reason: Glenmark Pharmaceuticals Europe Ltd is recalling a specific batch of Omeprazole Oral Solution as a precautionary measure due to an investigation following a customer complaint indicating precipitation and discoloration of the product in the bottles. A root cause has identified that this is a result of an inadequate assembly of the plunger stem and the cup which could lead to a premature mixing of the two components of the medicinal product.

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

Further Information

For medical information enquiries please use the following options by phone +44 08004 580 383 or email medical_information@glenmarkpharma.com

For stock control enquiries please email orders.uk@glenmarkpharma.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 2 recall-PI Depo-Medrone 80mg/2mL suspension for injection

A batch of Depo-Medrone has been released to the market with an error. The vial over label incorrectly states that the total vial content is 40 mg in 1 mL, when the correct total vial content is 80mg in 2 mL (with a concentration of 40mg/ml of methylprednisolone acetate).

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-depo-medrone-80-mg-in-2-ml-maxearn-limited-el-25-a-slash-29?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=bc49e601-5d15-4f12-b3b9-be4fddb3db61&utm_content=immediately

MHRA drug alert date 25/06/25

Further Information

For all medical information enquiries and information on this product, please email maxearnqa@maxearn.co.uk or telephone 01204 471 269.

For stock control enquiries please email maxearnqa@maxearn.co.uk or telephone 01204 471 269.

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-Kimmtrak 200 micrograms/mL concentrate for solution for infusion

Immunocore Limited is recalling the batches listed below as a precautionary measure. The recall is due to a decrease in potency identified during stability testing. All other stability test results remain within specification.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-kimmtrak-200-micrograms-slash-ml-concentrate-for-solution-for-infusion-immunocore-limited-el-25-a-slash-28?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=45800870-bf29-4be7-9270-c1a645ebf0b7&utm_content=immediately

MHRA drug alert date 25/06/25

Further Information

For all medical information enquiries and information on this product, please email medinfo.eu@immunocore.com, or telephone +442076645100 (local toll) or +00 800-74451111 (toll-free).

For stock control enquiries please email john.sandford@immunocore.com, or telephone +00353(0)858515258.

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 Inhixa 12,000IU (120mg)/0.8mL solution for injection

Maxearn Limited have informed the MHRA that the carton used to package two imported batches of Inhixa have been released to the market with a typographical error on one side of the carton.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-inhixa-12000iu-120mg-slash-0-dot-8ml-solution-for-injection-maxearn-limited-el-25-a-slash-27?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=225b3c3d-411e-4f22-9b63-30117bf0dac8&utm_content=immediately

MHRA drug alert date 12/06/25

Further Information

For all medical information enquiries and information on this product, please email eupvg@genreg.eu or telephone 020 7201 0421.

For stock control enquiries please email info@genesis-pharma.com or telephone 0207 201 0400.

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 - Dulcolax Adult 5 mg Gastro-resistant Tablets

Opella Healthcare UK LTD has informed the MHRA that there is an error on the artwork for the outer carton of Dulcolax Adult 5mg GR Tablets (packsize 20 count). The dose instruction incorrectly states for use in 12 years and older. These general sale packs are intended for use only in adult patients (18 years and over).

MHRA Drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-dulcolax-adult-5-mg-gastro-resistant-tablets-opella-healthcare-uk-el-25-a-slash-26?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=3758a495-ac74-45d7-aaf0-88314480fc30&utm_content=immediately

MHRA drug alert date: 10/06/25

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 uk-medicalinformation@sanofi.com, or telephone 0800 035 2525.

Class 2 recall-Paracetamol 500mg tab (100)

Chelonia Healthcare Limited is recalling specific batches of Paracetamol 500mg Tablets (100 pots) as a precautionary measure due to contamination following a small number of complaints of discoloured tablets within the pots.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-paracetamol-500mg-tablets-chelonia-healthcare-limited-el-25-a-slash-25?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=6cffbae9-5c8f-42f8-b5b0-6cf69d34ffb1&utm_content=immediately

MHRA drug alert date 09/06/25

Further Information

For all medical information enquiries and information on this product, please email eupvg@genreg.eu or telephone 020 7201 0421.

For stock control enquiries please email info@genesis-pharma.com or telephone 0207 201 0400.

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.