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SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 caution in use-Omeprazole 40mg Powder for solution for infusion

Generics (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in specific batches of Omeprazole 40 mg Powder for solution for infusion do not contain the most up to date safety information.

 

 

MHRA Drug alert date: 12th November 2024

 

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-viatris-uk-healthcare-ltd-omeprazole-40-mg-powder-for-solution-for-infusion-el-24-a-slash-54?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=b6521847-f0ea-4fbc-adc8-ba74059c9b3b&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

1170133

OMEPRAZOLE PDR VIAL 40MG MYL

VIATRIS

C017

D006Y

 

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

 

Further Information

For medical information and stock control queries please contact:

Viatris UK Healthcare Limited Medical Information at +44 (0)1707 853 000 (select option 1) or info.uk@viatris.com. Customer Services can be reached at +44 (0)1707 853 000 (select option 2).

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 caution in use-Zoledronic acid 4mg/5ml Solution

Ennogen Healthcare Limited has identified that action had not been taken to ensure the Patient Reminder Card (PRC) was distributed alongside the packs of product as part of the approved Additional Risk Minimisation Measures (RMM).

 

MHRA Drug alert date: 7th November 2024

 

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-ennogen-healthcare-limited-zoledronic-acid-ennogen-4mg-slash-5ml-concentrate-for-solution-for-infusion-el-24-a-slash-53?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=ae0d646e-30a4-4189-8027-c36d2c450c0b&utm_content=immediately

 

 

Pip code

Product description

Supplier

Batch Numbers

ALLIANCE DO NOT STOCK

ZOLEDRONIC ACID 4MG/5ML SOLUTION

ENNOGEN HEALTHCARE

35000341
35000387
35000389
35000390

 

 

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

 

Further Information

 

For medical information enquiries please contact MedicalInformation@ennogen.com

For stock control enquiries please telephone +44 (0)1322 629220

SUB-TYPE: CLASS 2 RECALL

Class 2 recall-Labetalol 200mg tablets

Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets as a precautionary measure due to potential mix-up at the manufacturing site.

 

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-tillomed-laboratories-limited-labetalol-200mg-tablets-el-24-a-slash-52?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=2e33e9ba-323e-48e8-a188-eb6c601fda3b&utm_content=immediately

 

 

Pip code

Product description

Supplier

Batch Numbers

8128183

LABETALOL TAB 200MG

 TILLOMED LABS

240537

 

 

Further Information

For all medical enquiries, please contact Tillomed Laboratories Limited by email at either medical.information@tillomed.co.uk or PVUK@tillomed.co.uk, or telephone 0800 9706115.

For enquiries relating to stock returns please email Tillomed Laboratories Limited customer services customer.service@tillomed.com or telephone 01480 402 400.

 

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-Parasolve 500mg

Kent Pharma UK has identified an error in the Patient Information Leaflet (PIL) for Paracetamol 500mg Effervescent Tablets.

 

MHRA Drug alert date: 28th October 2024

 

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-kent-pharma-uk-parasolve-paracetamol-500mg-effervescent-tablets-el-24-a-slash-51?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=5872b8d6-4416-46db-b971-7547e5419b92&utm_content=immediately

 

 

Pip code

Product description

Supplier

Batch Numbers

ALLIANCE DO NOT STOCK

PARASOLVE 500MG

KENT PHARMA

ALL

 

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

 

Further Information

For medical information enquiries please contact medical@kent-athlone.com

 

For stock control enquiries please contact customer.service@kent-athlone.com

SUB-TYPE: CLASS 2 RECALL

Class 2 recall-Phenobarbital tabs 15mg Bristol

Bristol Laboratories Ltd. are recalling one batch of Phenobarbital Bristol Labs 15mg Tablets as a precautionary measure due to the potential of contamination of small metallic particles within the tablets.

 

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-bristol-laboratories-ltd-phenobarbital-bristol-labs-15mg-tablets-el-24-a-slash-50?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=7ae4cb12-a098-4a7b-84d5-cf21de226896&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

ALLIANCE DO NOT STOCK

PHENOBARBITAL TAB 15MG

BRISTOL LABS

NU22001

 

 

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). 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-Paracetamol 500mg effervescent tablets Kent Pharma

Kent Pharma UK has identified an error in the Patient Information Leaflet (PIL) for Paracetamol 500mg Effervescent Tablets.

 

MHRA Drug alert date: 21st October 2024

 

MHRA drug alert linkhttps://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-kent-pharma-uk-paracetamol-500mg-effervescent-tablets-el-24-a-slash-49?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=5a1672aa-08cf-4721-b0cb-ba1f21ce6982&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

1221068

PARACETAMOL EFF TAB 500MG (100) Kent

Kent Pharma UK

ALL

8459380

PARACETAMOL EFF TAB 500MG (60)Kent

Kent Pharma UK

ALL

6290514

PARACETAMOL EFF TAB 500MG (24)Kent

Kent Pharma UK

ALL

8053076

PARACETAMOL EFF TAB 500MG (16)Kent

Kent Pharma UK

ALL

 

 

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

 

Further Information

For medical information enquiries please contact medical@kent-athlone.com

 

For stock control enquiries please contact customer.service@kent-athlone.com

SUB-TYPE: CLASS 4 CAUTION IN USE

Class 4 caution in use-Linezolid 600mg tablets

Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Linezolid 600 mg film-coated tablets.

 

MHRA Drug alert date: 10th October 2024

 

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-sandoz-ltd-dot-linezolid-600-mg-film-coated-tablets-el-24-a-slash-48?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=025d6ab9-9885-40e6-ab69-13bedf8bcd94&utm_content=immediately

 

Pip code

Product description

Supplier

Batch Numbers

8105298

LINEZOLID TAB 600MG

SANDOZ LTD

NS2637

 

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

 

Further Information

For medical information queries, please contact: sandozgb@EU.propharmagroup.com, Telephone: +44 1276 698 101.

 

For stock control queries, please contact: sales.sandoz-gb@sandoz.com, Telephone: +44 1276 698607.

SUB-TYPE: CLASS 3 RECALL

Class 3 recall-Trandolapril 2mg and 4mg Capsules Mylan

Generics (UK) Ltd T/A Mylan UK is recalling specific batches of trandolapril after re-testing showed out of specification results.

 

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-viatris-uk-healthcare-ltd-trandolapril-2mg-and-4mg-capsules-el-24-a-slash-47?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=089c0476-44ad-4de3-95eb-d62d62b8c195&utm_content=immediately

 

 

PIP CODE

PRODUCT DESCRIPTION

BATCH NUMBER

1119783

TRANDOLAPRIL CAP 2MG MYL

SEE ABOVE LINK

1139849

TRANDOLAPRIL CAP 4MG MYL

SEE ABOVE LINK

 

 

Further Information

 

For medical information enquiries please contact Viatris UK Healthcare Limited Medical Information at +44 (0)1707 853 000 (select option 1) or info.uk@viatris.com.

 

For stock control enquiries please contact Customer Services at +44 (0)1707 853 000 (select option 2).

 

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- Cyanocobalamin 50mcg tablets (Glenmark Livery

Glenmark Pharmaceuticals Europe Ltd is recalling the affected batches as a precautionary measure due to out of specification results for unknown impurities during routine stability testing and additional re-testing.

 

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-glenmark-pharmaceuticals-europe-ltd-cyanocobalamin-50-mcg-tablets-el-24-a-slash-46?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=856d3399-61cb-46ab-badf-8fa8c84a1e83&utm_content=immediately

 

              

PIP CODE

PRODUCT DESCRIPTION

BATCH NUMBER

1267335

CYANOCOBALAMIN TAB 50MCG GLE

17231378A

17231510A

17231511A

8042061

CYANOCOBALAMIN TAB 50MCG

17231378A

17231510A

17231511A

 

 

Further Information

 

For medical information enquiries please use the following options by phone +44 8004 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 4 CAUTION IN USE

Class 4 caution in use-Rosuvastatin 20mg & 40mg Sandoz

Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) for Rosuvastatin 20mg and 40mg Tablets.

 

MHRA Drug alert date: 1st October 2024

 

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-sandoz-ltd-dot-rosuvastatin-20mg-40mg-tablets-el-24-a-slash-45

 

Pip code

Product description

Supplier

Batch Numbers

6838262

ROSUVASTATIN TAB 20MG

SANDOZ LTD

NL8148   NW1590   NW1591

6838213

ROSUVASTATIN TAB 40MG

SANDOZ LTD

NJ2462   NU8004   NX2653   NU8003

 

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

 

Further Information

For medical information queries, please contact: sandozgb@EU.propharmagroup.com, Telephone: +44 1276 698 101.

 

For stock control queries, please contact: sales.sandoz-gb@sandoz.com, Telephone: +44 1276 698607.