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SUB-TYPE: CLASS 4 CAUTION IN USE

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MHRA that the Patient information leaflet (PIL) in the cartons for the batch listed in this notification includes a superseded PIL.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

 

p code

Product description

Supplier

Batch Numbers

90209

ERYTHROCIN FILMTAB 250MG

Amdipharm UK Ltd

6104532

 

 

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

 

SUB-TYPE: CLASS 3 RECALL

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

 

Pip code

Product description

Supplier

Batch Numbers

1048925

TAMOXIFEN TAB 20MG

WOCKHARDT

 

1038652

TAMOXIFEN TAB 20MG MYL

WOCKHARDT

HZ10030

1007368

TAMOXIFEN TAB 20MG WCK

WOCKHARDT

 

 

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.

 

SUB-TYPE: CLASS 3 RECALL

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. 

Pip code

Product description

Supplier

Batch Numbers

8061640

Omeprazole 20 mg/15 ml Oral Solution

Glenmark Pharmaceuticals

3230528

 

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.

SUB-TYPE: CLASS 2 RECALL

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

 

Pip code

Product description

Supplier

Batch Numbers

Alliance do not stock

PI Depo-Medrone 80mg/2mL suspension for injection

Quadrant Pharmaceuticals Limited / Maxearn Limited

LG3883 Max 0943Y

 

 

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.

SUB-TYPE: CLASS 3 RECALL

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

 

Pip code

Product description

Supplier

Batch Numbers

Alliance do not stock

Kimmtrak 200 micrograms/mL

Immunocore Limited

3D009AA17
3D009AA19
3D009AA36
3D009AA39
3D009AA04

 

 

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.

SUB-TYPE: CLASS 2 RECALL

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

 

Pip code

Product description

Supplier

Batch Numbers

ALLIANCE DO NOT STOCK

PI INHIXA 120MG/0.8ML PFS

Quadrant Pharmaceuticals Limited / Maxearn Limited

0191Y / AG07093D

 

9982X / AG11871C

 

 

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.

SUB-TYPE: CLASS 4 CAUTION IN USE

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

 

Pip code

Product description

Supplier

Batch Numbers

0002691

DULCOLAX LAXATIVE TABS 5MG

Opella Healthcare UK LTD

See above link

 

 

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.

SUB-TYPE: CLASS 2 RECALL

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

 

Pip code

Product description

Supplier

Batch Numbers

1018779

PARACETAMOL TAB 500MG ACC

CHELONIA HEALTHCARE LTD

2312010  2312011

 

 

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.

 

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 caution in use-Zentiva Pharma UK Limited, Various Product

Zentiva Pharma UK Limited has informed the MHRA of an issue related to batches of various soluble or effervescent tablets.

 

MHRA Drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-notification-zentiva-pharma-uk-limited-various-products-el-25-a-slash-24?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=0fc7bea3-f591-4a3e-8fc1-1d28e6bfa2ea&utm_content=immediately

 

MHRA drug alert date: 02/06/25

 

Pip code

Product description

Supplier

Batch Numbers

8032468

PARACETAMOL SOL TAB 500MG (24)

ZENTIVA PHARMA UK

See above link

Alliance do not stock

PARACETAMOL SOL TAB 500MG (100)

ZENTIVA PHARMA UK

See above link

Alliance do not stock

CO-CODAMOL EFF TAB 8/500MG (32)

ZENTIVA PHARMA UK

See above link

Alliance do not stock

CO-CODAMOL EFF TAB 8/500MG (100)

ZENTIVA PHARMA UK

See above link

Alliance do not stock

CO-CODAMOL EFF TAB 30/500MG (100)

ZENTIVA PHARMA UK

See above link

 

 

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 Zentiva medical information via webform, email UKmedinfo@zentiva.com or telephone 0800 090 2408.

For stock control enquiries please email ukcustomerservices@zentiva.com or telephone 08448 793188.

SUB-TYPE: CLASS 2 RECALL

Class 2 recall-BD ChloraPrep Clear - 1mL Applicator

Becton Dickinson UK Ltd has informed the MHRA that some units exhibit an open seal on the packaging of the applicator. This defect could increase the risk of the applicator device being contaminated with pathogens, which could lead to increased infection rates for the patients.

 

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-bd-chloraprep-clear-1ml-applicator-becton-dickinson-uk-ltd-el-25-a-slash-22?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=523232d5-0bdd-4537-8674-58051af969ec&utm_content=immediately

 

MHRA drug alert date: 19/05/25

 

Pip code

Product description

Supplier

Batch Numbers

Alliance do not stock

BD ChloraPrep Clear - 1mL Applicator

Becton Dickinson UK Ltd

See Above link

 

Further Information

 

For all medical information enquiries and information on this product, please email safetyinformation@bd.com, or telephone 08000437546.

For stock control enquiries please email info@insightbio.com, or telephone 01707351330.

 

 

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.