Letters and medicine recalls sent to healthcare professionals in December 2024
Source: gov.uk (2025-01-28)

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

Letters

In December 2024, the following letters were sent or provided to relevant healthcare professionals:
- Medikinet® XL▼10mg capsules and Medikinet® XL▼20mg capsules (methylphenidate hydrochloride) - Voluntary Notification Defective Medicine (https://assets.publishing.service.gov.uk/media/6793b4e07b75412c254f4b2b/Dear_HCP_Medikinet_XL_caps_-_v1.1_Headed_Paper.pdf)
- Xevudy® (sotrovimab) 500 mg concentrate for solution for infusion: Important information for healthcare professionals about the expiry date of all packs (https://assets.publishing.service.gov.uk/media/6793b2f67b75412c254f4b28/Xevudy.pdf)
- Hydroxocobalamin - Cyanokit® 5 g powder for solution for infusion: – Important information regarding batch 2404 in a product shortage context (https://assets.publishing.service.gov.uk/media/6793b245e863a0e7724f4b33/24_153_GHE_Cyanokit_-_DHPC_2404_UK.pdf)
- Fucithalmic 1% w/w Viscous Eye Drops/ Fusidic acid 1% w/w Viscous Eye Drops - Interim supply of Chinese stock to Mitigate supply disruption (https://assets.publishing.service.gov.uk/media/6793b2bac74f1dca7492f39e/Direct_Healthcare_Professional_Communication_Letter__003_.docx.pdf)
- Movymia 20 micrograms/80 microliters solution for injection▼ (teriparatide): Interim Supply of Italian Stock to Mitigate Supply Disruption (https://assets.publishing.service.gov.uk/media/6793b29b7b75412c254f4b27/DHPC_Movymia-IT-241121-signed-Italian.pdf)
- Ocrevus® (ocrelizumab) 920 mg solution for injection: Significant update to premedication administration timing for patients on Ocrevus in Northern Ireland (NI) to align with the UK Summary of Product Characteristics (SmPC) from 1st January 2025, as a result of the Windsor Framework Agreement (https://assets.publishing.service.gov.uk/media/6793b2d4e863a0e7724f4b34/Ocrevus.pdf)
- COLUMVIⓇ▼ (glofitamab): Significant Update on Patient Monitoring Requirements for New and Existing Patients on COLUMVI in Northern Ireland (NI) to align with the UK Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) from 1st January 2025 (https://assets.publishing.service.gov.uk/media/6793b263c74f1dca7492f39d/Columvi_MHRA_Final_Approved_Letter_Dec2024.pdf)
- Abrysvo ®▼ powder and solvent for solution for injection (respiratory syncytial virus vaccine (bivalent, recombinant)): Change of Marketing authority from EMA to MHRA in effect from 1st January 2025 resulting in change to Posology for pregnant individuals (https://assets.publishing.service.gov.uk/media/6793b27f2de28ea2d392f3a0/DHCP_abrysvo_letter_signed_18dec24.pdf)
Medicine Recalls and Notifications

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

Class 2 Medicines Recall: Wockhardt UK Limited, WockAIR 160 microgram/4.5 microgram, inhalation powder, EL(24)A/62 (https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-wockhardt-uk-limited-wockair-160-microgram-slash-4-dot-5-microgram-inhalation-powder-el-24-a-slash-62). Issued 9 December 2024. Wockhardt UK Limited is recalling this batch as a precautionary measure following the identification of a low number of units which may have a defect in the ‘top case’ resulting in a dose not being able to be dispensed.

Class 3 Medicines Recall: Kent Pharma UK, Phenoxymethylpenicillin 250mg/5ml Oral Solution Sugar Free, EL (24)A/60 (https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-kent-pharma-uk-phenoxymethylpenicillin-250mg-slash-5ml-oral-solution-sugar-free-el-24-a-slash-60). Issued 3 December 2024. Kent Pharma UK is recalling a batch of phenoxymethylpenicillin 250mg/5mL oral solution sugar free due to a low phenoxymethylpenicillin assay.

Class 4 Medicines Defect Information: Rosemont Pharmaceuticals Limited, Mycophenolate Mofetil 1g/5ml Oral Suspension, EL(24)A/59 (https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-rosemont-pharmaceuticals-limited-mycophenolate-mofetil-1g-slash-5ml-oral-suspension-el-24-a-slash-59). Issued 2 December 2024. Rosemont Pharmaceuticals Limited has informed the MHRA that the Press-In-Bottle-Adaptor (PIBA) supplied with the batches listed above may cause the medicine to leak when attempting to withdraw a dose.

Class 4 Medicines Defect Information: Brillpharma Limited, Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution, EL(24)A/61 (https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-brillpharma-limited-oxybutynin-hydrochloride-brillpharma-2-dot-5-mg-slash-5-ml-oral-solution-el-24-a-slash-61). Issued 4 December 2024. L M Manufacturing Limited has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batch listed for Oxybutynin hydrochloride Brillpharma 2.5 mg/5 ml Oral Solution include an out of date PIL, dated July 2021.

Class 4 Medicines Notification: Argenx BV, Vyvgart 1000 mg solution for injection, EL (24)A/63. (https://www.gov.uk/drug-device-alerts/class-4-medicines-notification-argenx-bv-vyvgart-1000-mg-solution-for-injection-el-24-a-slash-63) Issued 19 December 2024. Argenx BV have informed MHRA that the Patient Information Leaflet (PIL) in the affected packs incorrectly contains reference to two subcutaneous injection sites. Only subcutaneous injection to the abdomen is permitted.

MHRA Safety Update volume 18, issue 6: January 2025: 2