Letters and medicine recalls sent to healthcare professionals in December 2023

A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 22 January 2024

Letters

In December 2023, the following letters were sent or provided to relevant healthcare professionals:

• Oncaspar 750 U/ml powder for solution for injection/infusion: Interim Supply of Irish Stock to Mitigate Supply Disruption
• Biktarvy▼30 mg/120 mg/15 mg film-coated tablets (bictegravir 30mg/ emtricitabine 120mg/ tenofovir alafenamide 15mg): Interim Supply of Ireland-Northern Ireland-Malta Stock to Mitigate Supply Disruption
• Xevudy®▼(sotrovimab) 500 mg concentrate for solution for infusion: Important information for healthcare professionals about the expiry date of all packs
• VERORAB, powder and solvent for suspension for injection: Interim Supply of UK Stock in Standard Export Packaging (Standard Export Packs) to Mitigate Supply Disruption

Medicine Recalls and Notifications

In December 2023, recalls and notifications for medicines were issued on:

Class 4 Medicines Defect Information: Strandhaven Ltd t/a Somex Pharma, Tramadol Hydrochloride 50mg Capsules, Hard, EL (23)A/41. Issued on 6 December 2023. 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. The PIL does not include the most up to date safety information for drug interaction of antidepressants with Tramadol, sleep-related breathing disorders, adrenal insufficiency, hiccups, and serotonin syndrome, and the need to seek medical advice if they occur.

Class 4 Medicines Defect Information: Strandhaven Ltd t/a Somex Pharma, Clarithromycin 250mg and 500mg film-coated tablets, EL (23)A/42. Issued 6 December 2023. 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. The PIL does not include the most up to date safety information.

Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension, EL(23)A/43. Issued 13 December 2023. Atnahs Pharma UK Ltd has informed the MHRA that the batches of Clobazam Atnahs 5mg/5ml and 10mg/5ml Oral Suspension listed in this notification do not contain the most up to date safety information. The Summary of Product Characteristics (SmPC) and the Patient Information Leaflets (PIL) present in the pack are missing significant information. This is in relation to the use of the product in children (contraindicated), pregnancy, depression, drug dependence, numerous interactions and adverse effects which are missing from the PIL present in the pack and in the SmPC.

Class 3 Medicines Recall: Biocon Pharma UK Ltd., Posaconazole Biocon 100mg Gastro-resistant Tablets, EL(23)A/44. Issued 14 December 2023. Biocon Pharma UK Limited are recalling a specific of batch Posaconazole 100mg Gastro-resistant Tablets due to an out of trend result for unspecified impurities during testing for stability. The batch is likely to be out of specification before the expiry date and therefore the batch is being recalled as precautionary measure.

Article citation: Drug Safety Update Volume 17, issue 6, January 2024: 4.

Published 22 January 2024