Letters and medicine recalls sent to healthcare professionals in September 2024

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

• From: Medicines and Healthcare products Regulatory Agency
• Published: 24 October 2024

• Therapeutic area: GI, hepatology and pancreatic disorders, Haematology, Infectious disease, Neurology, Nutrition and dietetics, Psychiatry and Rheumatology

Letters

In September 2024, the following letters were sent or provided to relevant healthcare professionals:

• Oxbryta (voxelotor): Withdrawal from UK market
• BLENREP▼ (Belantamab mafodotin): Revocation of the Great Britain conditional Marketing Authorisation for BLENREP (belantamab mafodotin)
• Valproate - containing medicines▼: new measures regarding the potential risk of neurodevelopmental disorders in children of fathers treated with valproate in the 3 months prior to conception
• Tyenne 162 mg solution for injection in pre-filled pen (PFS) - PLGB 08828/0357: Temporary Supply of German labelled stock
• NOXAFIL® (posaconazole) new Gastro-Resistant Powder and Solvent for Oral Suspension not interchangeable with existing Oral Suspension including generics.
• Fresenius Kabi compounded parenteral nutrition products: use of Inline filters during administration now required
• Creon® Micro Pancreatin 60.12mg Gastro-resistant Granules: Interim Supply of Spanish Stock to Mitigate Supply Disruption

Medicine Recalls and Notifications

In September 2024, recalls and notifications for medicines were issued on:

Class 3 Medicines Recall: Theramex HQ UK Ltd, Evorel Sequi, EL (24)A/41. Issued 12 September 2024. Theramex has informed the MHRA that some cartons of Evorel Sequi contain the incorrect combination of patches. An error at the packaging site means that a limited number of packs have the incorrect combination of Evorel 50 and Evorel Conti patches.

Class 3 Medicines Recall: Orion Pharma (UK) Ltd, Eldepryl 5mg Tablets (selegiline), EL(24)A/42. Issued 18 September 2024. Orion Pharma (UK) Ltd is recalling this batch as a precautionary measure due to an out of specification result in the assay result during the follow up stability study of the batch.

Class 4 Medicines Defect Information: Sandoz Ltd., Risperidone 1mg, 2mg, 3mg Tablets, EL(24)A/43. Issued 26 September 2024. 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 Risperidone 1mg, 2mg and 3mg and Tablets.

Class 2 Medicines Recall: Pfizer Limited, Oxbryta 500mg Tablets (voxelotor), EL(24)A/44. Issued 30 September 2024. Pfizer Limited is recalling all distributed batches of Oxbryta 500 mg Tablets. Pfizer Limited has informed the MHRA that the product is being withdrawn due to emerging data from clinical trials and registry-based studies.

Article citation: MHRA Safety Update volume 18, issue 3: October 2024: 4

Published 24 October 2024