Class 4 Caution in use- Various products

Cipla (EU) Limited, UK and Pharmathen S.A. have informed the MHRA that the outer carton (box) of the product batches mentioned in this notification are missing the medicines legal classification for a Prescription Only Medicine (POM).

MHRA drug alert date: 13th July 2023

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-4-medicines-notification-cipla-uk-limited-and-pharmathen-s-dot-a-various-products-el-23-a24?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=b6c0ae7e-abfa-4f60-9c6b-067b05d5984f&utm_content=immediately

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

Further Information

Cipla (UK) Limited

For more information regarding Cipla (EU) Limited, UK products, medical or supply enquiries, please contact telephone: +44 (0) 800 047 2144 or via email: drugsafety@Cipla.com & Uk.info@Cipla.com

Pharmathen S.A

For more information regarding Pharmathen S.A products, medical or supply enquiries, please contact telephone: +30 210 6604300 or via email: pharmacovigilance@pharmathen.com & info@pharmathen.com

Class 2 recall-Labetelol 200mg tablets

Tillomed Laboratories Limited is recalling one batch of Labetalol 200mg Tablets due to an error on the foil blister packaging.

MHRA drug alert date: 10th July 2023

MHRA Drug alert link:https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-tillomed-laboratories-limited-labetalol-200mg-tablets-el-23-a-slash-23?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=bc26380b-3aac-4997-a8ec-fb2dbd985b2b&utm_content=immediately

For all medical enquiries, please contact medical information at Tillomed Laboratories Limited by email to medical.information@tillomed.co.uk or PVUK@tillomed.co.uk or by telephone +44 (0)1480 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.

class 2 recall-Dacarbazine 100mg, 200mg & 500mg powder for solution

medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to pink discolouration of the dacarbazine solution immediately after reconstitution (after correct preparation and storage).

MHRA Drug alert link: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-medac-gmbh-t-slash-a-medac-pharma-llp-dacarbazine-100mg-200mg-and-500mg-powder-for-solution-for-injection-vials-el-23-a-slash-22?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=a93dd3dd-bc51-450a-af44-322478241b22&utm_content=immediately

For all medical enquiries, please contact medical information at medac Pharma LLP by email to info@medacpharma.co.uk or by telephone 01786 458086.

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.

class 3 recall-Sildenafil 100mg tablets (4)

Strandhaven Limited T/A Somex Pharma has informed the MHRA that the pack size on some cartons of the batch in this notification state 8 tablets instead of 4 tablets.

MHRA Drug alert link:  https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-strandhaven-limited-t-slash-a-somex-pharma-sildenafil-100mg-film-coated-tablets-el-23-a-slash-21?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=b8c33aca-6f1b-4cbf-9687-260318602393&utm_content=immediately

For medical information enquiries please contact email: regulatory@somexpharma.com, Tel: 020 8590 9399, choose option 3 or 4.

For stock control enquiries please contact email: regulatory@somexpharma.com, Tel: 020 8590 9399, choose option 3 or 4.

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.

company-led recall: Vitabiotics Omega-H3 capsules

Due to an error during a carton design update, the allergen ‘Wheat’ was not highlighted in bold. However, the presence of wheat is correctly and clearly indicated in the ingredients list as ‘Wheat Germ Oil’ (from Wheat)’.

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- Medical Oxygen B.P (MEDIGAS OXYGEN B.P)

 The Medicines and Healthcare products Regulatory Authority (MHRA) has been made aware that falsified medical oxygen has been provided to several dental practices across the UK. You may have received an email from the Care Quality Commission alerting you to this issue. The source of the supply has been identified as batches provided by Tricodent Limited. An assessment of risk to public health and patient safety has been completed and the risk was found to be low. A criminal investigation into the company that supplied this stock is ongoing. The falsified product in circulation is labelled: Medical Oxygen B.P PL No 04280/0001 MEDIGAS OXYGEN.

MHRA drug alert date  6th June 2023

MHRA Ref: MDR 053-04/23

Further Information

Authorised and licensed suppliers can offer advice regarding disposal of falsified cylinders, do not return cylinders to Tricodent Limited. For further information on this issue from the MHRA, please contact MHRA Senior Criminal Enforcement Officer Mark Ling: Mark.Ling@mhra.gov.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- Metronidazole 200 mg/5 ml Oral Suspension

Drugsrus Limited has informed the MHRA that a small number of bottles of Metronidazole 200 mg/5 ml Oral Suspension 100ml are leaking from the cap.

MHRA drug alert date: 23rd May 2023

MHRA drug alert link:  https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-drugsrus-limited-slash-dawa-limited-metronidazole-200-mg-slash-5-ml-oral-suspension-el-23-a-slash-19?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=10f3e44b-274c-4301-ad8e-9eb2779bb944&utm_content=immediately

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

Further Information

For more information, medical or supply enquiries, please contact Drugsrus Limited on 020 8423 3800, or email info@drugsrus.co.uk.

Class 4 Caution in use- Buccolam 10mg

Orifarm UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in one batch of Buccolam 10mg Oromucosal solution has missing information regarding having to break the seal on the inner container before use.

MHRA drug alert date: 22nd May 2023

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-orifarm-uk-ltd-buccolam-10mg-oromucosal-solution-el-23-a-slash-18?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=d06c9595-2c98-4c18-90d1-5b738d6dc70d&utm_content=immediately

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

Further Information

For more information, medical or supply enquiries, please contact 01276 698370, or email uk_enquiries@orifarm.com

Class 4 Caution in use- Simulect 10mg & 20mg powder and solvent for Solution for injection or infusion

Novartis Pharmaceuticals has informed the MHRA that the solvent (water for injections in ampoules) co-packed with the impacted batches of Simulect powder for injection, may contain glass fragments approximately 20 – 800 µm in size.

MHRA drug alert date: 16th May 2023

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-novartis-pharmaceuticals-simulect-10mg-and-20mg-powder-and-solvent-for-solution-for-injection-or-infusion-el-23-a-slash-17?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=d08ff9e2-3185-4fca-b71c-1083f3f9bff0&utm_content=immediately

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

Further Information

For more information, medical or supply enquiries, please contact 01276 698370, or email medinfo.uk@novartis.com

class 3 recall- Gemcitabine 1g/26.3ml & 2g/52.6ml Solution For Infusion Vial

Hikma Farmacêutica Portugal S.A has informed the MHRA of a potential issue impacting the batches listed in this notification.

MHRA Drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-hikma-farmaceutica-portugal-s-dot-a-gemcitabine-1g-slash-26-dot-3ml-and-2g-slash-52-dot-6ml-solution-for-infusion-vial-el-23-a-slash-16

For more information or medical information queries, please contact: Portugalcomplaints@hikma.com or Portugaleupharmacovigilance@hikma.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.