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Updates

SUB-TYPE: CLASS 3 RECALL

Class 3 recall- Cyclizine Lactate 50 mg/ml Solution for injection

Orbit Pharma Limited is recalling a specific batch of Cyclizine Lactate 50 mg/ml Solution for injection as a precautionary measure due to Good Manufacturing Practice (GMP) deficiencies identified at the manufacturing site.

 

 

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-orbit-pharma-limited-cyclizine-lactate-50-mg-slash-ml-solution-for-injection-el-26-a-slash-29?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=5b8f7581-e919-44d3-a4fe-981a9bdc0779&utm_content=immediately

 

MHRA drug alert date: 16/06/26

 

Pip code

Product description

Supplier

Batch Numbers

8015059

CYCLIZINE LACT INJ 50MG/ML

Orbit Pharma Limited

2226016

1195577

CYCLIZINE LACT INJ 50MG/ML AMC

Orbit Pharma Limited

2226016

 

 

Additional information:

For medical information enquiries and information on this product, please email customerservice@novumgen.com or telephone +44 203 096 6496. 

For stock control enquiries please email Stockcontrol@novumgen.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 4 CAUTION IN USE

Class 4 caution in use-Mirtazapine 30mg Tablets

Cadila Pharmaceuticals Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of a batch of Mirtazapine 30mg Film-Coated Tablets distributed in Crescent Pharma Limited livery.

 

MHRA drug alert Date: 11/6/26

 

MHRA drug alert link: Class 4 Medicines Defect Notification: Cadila Pharmaceuticals Limited, Mirtazapine 30mg Tablets, EL(26)A/28 - GOV.UK

 

pip codeProduct descriptionSupplierBatch Numbers
Alliance do not stockMIRTAZAPINE TAB 30MGCadila Pharmaceuticals Limited

ET570E5012

 

 

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

 

Further Information

 

For medical information enquiries please contact pharmacovigilance-eu@cadilapharma.com or telephone +44 1217901596

For stock control enquiries please contact info@crescentpharma.com or telephone 01256 772730

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 caution in use-Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe

Teva UK Limited is reporting a labelling error on the carton for Ponlimsi (Denosumab) 60mg Solution for injection in Pre-filled Syringe. The carton states “For application to the skin” when the product is licensed for subcutaneous use.

 

MHRA drug alert Date: 4/6/26

 

MHRA drug alert link:Class 4 Medicines Defect Notification: Teva UK Ltd, Ponlimsi (Denosumab) 60mg Solution for Injection in Pre-filled Syringe, EL(26)A/27 - GOV.UK

 

 

pip codeProduct descriptionSupplierBatch Numbers
4371142PONLIMSI 60MG PFSTEVA UK LTD 

184472

186711

188656

 

 

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@tevauk.com

For stock control enquiries please email Customer.services@tevauk.com

 

SUB-TYPE: CLASS 2 RECALL

Class 2 recall-ChloraPrep 2% 1mL and ChloraPrep Frepp 2% 1.5mL applicators

Becton Dickinson UK Ltd are recalling batches of ChloraPrep 2% 1mL applicators and ChloraPrep Frepp 2% 1.5 mL applicators due to a potential breach of sterility in the packaging process.

 

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-becton-dickinson-uk-ltd-chloraprep-2-percent-1ml-and-chloraprep-frepp-2-percent-1-dot-5ml-applicators-el-26-a-slash-26?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=af065c4b-ae7c-4e93-b509-48708827dd95&utm_content=immediately

 

MHRA drug alert date: 02/06/26

 

Pip code

Product description

Supplier

Batch Numbers

n/a

ChloraPrep 2% w/v / 70% v/v cutaneous solution 1mL applicators

Becton Dickinson UK Ltd

See attached

n/a

ChloraPrep Frepp 2% w/v / 70% v/v cutaneous solution 1.5 mL applicators

Becton Dickinson UK Ltd

See attached

 

 

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.

SUB-TYPE: CLASS 2 RECALL

Class 2 recall- Ramipril caps 2.5mg

Crescent Pharma Limited is initiating a precautionary recall of one batch of Ramipril 2.5 mg Capsules following the identification of a potential packaging error at the manufacturing site.

 

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-crescent-pharma-limited-ramipril-2-dot-5-mg-capsules-el-26-a-slash-25?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=5c7ce4ea-d2a7-4959-9ebb-78481e349fed&utm_content=immediately#background

 

MHRA drug alert date: 28/05/26

 

Pip code

Product description

Supplier

Batch Numbers

1111533

RAMIPRIL CAP 2.5MG TEV

Crescent Pharma Limited

GR155023

1112580

RAMIPRIL CAP 2.5MG ACC

Crescent Pharma Limited

GR155023

1117852

RAMIPRIL CAP 2.5MG ALM

Crescent Pharma Limited

GR155023

1219492

RAMIPRIL CAP 2.5MG WCK

Crescent Pharma Limited

GR155023

1276054

RAMIPRIL CAP 2.5MG SDZ

Crescent Pharma Limited

GR155023

 

Additional information:

For all medical information enquiries, please email medinfo@crescentpharma.com or telephone +44 1217901596.

For stock control enquiries please email complaints@crescentpharma.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 4 CAUTION IN USE

Class 4 caution in use-balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis

Fresenius Medical Care Deutschland GmbH have identified an error in the Braille printed on the outer label. The Braille message on the balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis, incorrectly states ‘CAPD/DPCA 19’. All other label information and printed data are correct for all above listed batches.

 

MHRA drug alert Date: 14/5/26

 

MHRA drug alert link:Class 4 Medicines Defect Notification: Fresenius Medical Care Deutschland GmbH, balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis, EL(26)A/24 - GOV.UK

 

 

pip codeProduct descriptionSupplierBatch Numbers
Alliance do  not stockbalance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysisFresenius Medical Care Deutschland GmbHF4LM071
G4LB133
G4LL144
G4LM152
H4LB212
G4LI151

 

 

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-UK@freseniusmedicalcare.com, or telephone 01623 445 215. For stock control enquiries please email ukorders@freseniusmedicalcare.com, or telephone 01623 445 100.

 

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 caution in use-Loperamide hydrochloride 2 mg Orodispersible Tablets

Milpharm Limited has identified a discrepancy in the Patient Information Leaflet (PIL) approved for Loperamide hydrochloride 2 mg Orodispersible Tablets.

 

MHRA drug alert Date: 11/5/26

 

MHRA drug alert link:Class 4 Medicines Defect Notification: Milpharm Limited, Loperamide hydrochloride 2 mg Orodispersible Tablets, EL(26)A/23 - GOV.UK

 

Pip code

Product description

Supplier

Batch Numbers

8103012

LOPERAMIDE OD TAB 2MG (6)

Milpharm Limited

25882X2

Alliance do  not stock

LOPERAMIDE OD TAB 2MG (12)

Milpharm Limited

25882X3

 

 

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@aurobindo.com, or telephone 020 8845 8811.

For stock control enquiries please email customerservices.uk@aurobindo.com, or telephone 020 8845 8811.

SUB-TYPE: CLASS 2 RECALL

Class 2 recall-Sertraline 100mg tablets

Amarox Limited is recalling one batch of Sertraline 100 mg film-coated tablets as a precautionary measure due to an error at the manufacturing site.

 

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-amarox-limited-sertraline-100mg-film-coated-tablets-el-26-a-slash-22?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=2339f367-dda6-4275-90fc-0e7281517b0d&utm_content=immediately

 

MHRA drug alert date: 28/04/26

 

Pip code

Product description

Supplier

Batch Numbers

1132612

SERTRALINE TAB 100MG ALM

Amarox Limited

V2500425

1125152

SERTRALINE TAB 100MG TEV

Amarox Limited

V2500425

1179407

SERTRALINE TAB 100MG ACC

Amarox Limited

V2500425

 

 

Further Information

For all medical information enquiries, information and for reporting of side effects please email Safety@Amaroxpharma.com or telephone +44 2039720005 and for stock control enquiries please email info@amaroxpharma.com or telephone +44 2039720002.

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-Napralief 9s

Omega Pharma Ltd is recalling specific batches of Napralief 250mg Gastro-Resistant Tablets due to missing text in Section 2 and Section 3 of the Patient Information Leaflet (PIL) and on the Carton in packs of Napralief 250mg Gastro-resistant tablets.

 

MHRA drug alert link: Class 3 Medicines Recall: Omega Pharma Ltd, Napralief 250mg Gastro-Resistant Tablets, EL(26)A/21 - GOV.UK

 

MHRA drug alert date:23/04/26

 

Pip code

Product description

Supplier

Batch Numbers

4365961

NAPRALIEF 9S

 OMEGA PHARMA LIMITED

B51496
B51497
B51102

 

 

Further Information

For all medical information enquiries, stock control queries and information on this product, please email UKLOcustomerservice@perrigo.com or call +44 0203 598 9603.

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-PI Hiprex 1g tablets

Doncaster Pharma Limited has informed the MHRA of an error related to the Braille embossing on the outer packaging of certain parallel imported batches of Hiprex 1 g tablets (POM).

 

MHRA drug alert Date: 26/3/26

 

MHRA drug alert link: Class 4 Medicines Defect Notification: Doncaster Pharma Limited, Hiprex 1g tablets, EL(26)A/20 - GOV.UK

 

Pip code

Product description

Supplier

Batch Numbers

8062713

PI HIPREX TAB 1G

Doncaster Pharma Limited

251352/BA
251358/BA
252137/BA
252137/BB
251358/BB

 

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 regulatory@doncasterpharma.co.uk or quality.enquiries@doncasterpharma.co.uk, or telephone 01302 365 000.

For stock control enquiries, please email commercial@doncasterpharma.co.uk, or telephone 01302 365 000.