Class 4 caution in use- Clarithromycin 250mg and 500mg

Strandhaven Limited t/a Somex Pharma has informed the MHRA regarding an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Clarithromycin 250mg and 500mg film-coated tablets.

MHRA drug alert date: 6th December 2023

MHRA drug alert link:  https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-strandhaven-ltd-t-slash-a-somex-pharma-clarithromycin-250mg-and-500mg-film-coated-tablets-el-23-a-slash-42

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

Further Information

For more information, medical information queries, contact: regulatory@somexpharma.com, tel: 020 8590 9399, choose option 3 or 4.

For stock control queries, contact: accounts@somexpharma.com, tel: 020 8590 9399, choose option 2.

Class 4 caution in use- Tramadol 50mg capsules

Strandhaven Limited t/a Somex Pharma has informed the MHRA regarding an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Tramadol Hydrochloride 50mg Capsules, Hard

MHRA drug alert date: 6th December 2023

MHRA drug alert link:https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-strandhaven-ltd-t-slash-a-somex-pharma-tramadol-hydrochloride-50mg-capsules-hard-el-23-a-slash-41?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=58cc3b9b-942b-448f-8503-aaeab8d73d7d&utm_content=immediately

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

Further Information

For more information, medical information queries, contact: regulatory@somexpharma.com, tel: 020 8590 9399, choose option 3 or 4.

For stock control queries, contact: accounts@somexpharma.com, tel: 020 8590 9399, choose option 2.

Class 4 caution in use-Caramet 25/100mg CR Tablet

Teva UK Limited, the Marketing Authorisation Holder (MAH) has informed the MHRA of a labelling error for the batch listed in this notification

MHRA drug alert date: 4th December 2023

MHRA drug alert link:  https://www.gov.uk/drug-device-alerts/class-4-medicines-notification-teva-uk-ltd-dot-caramet-25-slash-100mg-cr-tablets-el-23-a-slash-40?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=fb44128a-df16-4382-837c-9ec3a1412da8&utm_content=immediately

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

Further Information

For medical information queries, please contact Teva UK Limited Medical Information via phone on 0207 540 7117 or via email medinfo@tevauk.com.

For stock control queries, please contact Teva UK Limited Customer Solutions via phone on 0800 590502 or via email customer.services@tevauk.com.

Class 3 recall-Fluenz Tetra nasal spray suspension.

AstraZeneca UK Ltd. has informed the MHRA of an issue related to the expiry dates for certain batches of Fluenz Tetra. This recall provides further advice on the safe use of the product up to the amended expiry date.

MHRA Drug alert link: https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-astrazeneca-uk-ltd-dot-fluenz-tetra-nasal-spray-suspension-el-23-a-slash-39?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=7d47971e-3b90-4324-907c-33274035a69c&utm_content=immediately

Further information

For medical information enquiries please contact AstraZeneca Medical Information medical.informationUK@astrazeneca.com or call 0800 783 0033.

Fluenz Tetra remains available to order by NHS providers of the children’s flu programme in England and Wales via the ImmForm website (Helpdesk: 0207 183 8580 or Helpdesk@immform.org.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.

Customer level recall-Specific brands of carbomer eye gel

Specific batches of carbomer gel are being recalled as a precaution due to possible microbiological contamination.

MHRA Drug alert link:

https://www.gov.uk/drug-device-alerts/specific-brands-of-carbomer-eye-gel-recall-of-aacarb-eye-gel-aacomer-eye-gel-and-puroptics-eye-gel-potential-risk-of-infection-dsi-slash-2023-slash-11?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=c596e044-f42d-4f51-8f4f-16dc07374147&utm_content=immediately

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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 4 caution in use- Zinacef Vials (all strengths)

Sandoz has detected that information on the diluents in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) of cefuroxime contain incorrect information.

MHRA drug alert date: 23rd October 2023

MHRA drug alert link: https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-sandoz-limited-zinacef-powder-for-solution-for-injection-or-infusion-vials-all-strengths-including-stock-in-gsk-livery-el-23-a-slash-38?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=deab3b91-5e05-461a-94d7-cc812d40c9b7&utm_content=immediately

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

Further Information

For more information, 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

Company led recall-Smith And Nephew products

Smith and Nephew have informed us of an issue with some batches of their products

Reason: certain batches of No-Sting SKIN-Prep Wipes and No-Sting SKIN-Prep Swabs had a manufacturing error resulting in the presence of acetic acid causing a vinegar-like odor and potential minor skin irritation.”

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.

Company-led recall Temozolomide 5mg Capsules (Sun Pharma)

Sun Pharma UK Ltd has informed us of an issue with a batch of Temozolomide 5mg Capsules 

MHRA drug alert date: 17th October 2023

Please be aware this product is cytotoxic and must be stored and packaged carefully in the interest of health and safety 

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- Max Remedies Paracetamol 500mg capsules (16)

Max Remedies has identified an infrequent printing error relating to the Braille text printed on the cartons of various batches of this product.

MHRA drug alert date: 27th September 2023

MHRA drug alert link:  https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-max-remedies-ltd-max-healthcare-paracetamol-500-mg-capsules-el-23-a-slash-37?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=3a882fbc-123a-44ae-ad2f-adb1b18c64a0&utm_content=immediately

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

Further Information

For medical information enquiries or stock control enquiries please email Gary.Elliott@ivcbrunel.co.uk or telephone 07720740832

Class 3 recall-Trimbow Inhaler 87MCG/5MCG/9MCG

Chiesi Ltd has informed the MHRA about a potential issue with the batches listed in this notification. As a precautionary measure, Chiesi Ltd is recalling the above batches at the pharmacy and wholesale level. This is due to intermittent high results for the uniformity of delivered dose of formoterol fumarate observed during stability testing

MHRA Drug alert link: 

https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-chiesi-ltd-dot-trimbow-87-slash-5-slash-9-mcg-pressurised-inhalation-solution-el-23-a-slash-36?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=bb32a034-c0f7-469c-85a6-0003b4ad9b38&utm_content=immediately

Further information

For medical information enquiries please contact medinfo.uk@chiesi.com or telephone 0161 488 5555.

For stock control enquiries please contact customerservices.uk@chiesi.com or telephone 0161 488 5521.

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.