GovWire

Letters

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

• VABYSMO?(faricimab): tear in primary packaging of Transfer Filter Needle (TFN) co-packaged with vial; localised in Northern Ireland
• VERORAB, powder and solvent for suspension for injection - PLGB 46602/0029 Interim Supply of UK Stock in Standard Export Packaging (Standard Export Packs) to Mitigate Supply Disruption

Medicine Recalls and Notifications

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

Class 4 Medicines Defect Information: Manx Healthcare Ltd., Betamethasone Valerate 0.1% Ointment, EL(24)A/18. Issued 3 June 2024. Manx Healthcare Ltd. has informed MHRA that they have identified a problem with the product packaging of the batch indicated in the table. The tamper-evident seal on the outer carton may be missing or deformed on some packs. This is due to an intermittent equipment fault during secondary packaging.

Class 3 Medicines Recall: Neuraxpharm UK Ltd, Atomoxetine 10mg, 18mg, 25mg, 40mg Capsules, EL(24)A/19. Issued 5 June 2024. Neuraxpharm UK Ltd is recalling the above batches after retesting showed out of specification results. The tabled batches are being recalled as a precautionary measure after testing showed variability of the capsule contents beyond permitted levels.

Class 2 Medicines Recall: Desitin Pharma UK Ltd, Lamotrigine Desitin 10mg/ml Oral Suspension, EL(24)A/20. Issued 6 June 2024. Desitin Pharma UK Ltd is recalling all batches of Lamotrigine Desitin 10mg/ml Oral Suspension as a precautionary measure due to an out of specification observation in the appearance of samples during routine stability testing. Please note this is a Class 2 Patient, Pharmacy and Wholesaler level recall.

Class 4 Medicines Defect Information: Dawa Limited, Paracetamol 500mg, 1000mg Film-Coated Tablets, EL (24)A/21. Issued 10 June 2024. Dawa Limited has informed the MHRA that specified batches listed in this notification have been packed with an outdated Patient Information Leaflet (PIL).

Class 4 Medicines Defect Information: Viatris UK Healthcare Ltd, Oxcarbazepine Mylan 150mg, 300mg, 600mg Film-Coated Tablets, EL (24)A/22. Issued 17 June 2024. Viatris UK Healthcare Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in the specified batches of Oxcarbazepine 150 mg, 300 mg & 600 mg Film-Coated Tablets do not contain the most up to date safety information.

Class 3 Medicines Recall: Teva UK Limited, GoResp Digihaler, EL (24)A/23. Issued 18 June 2024. Teva UK Limited has informed the MHRA that it plans to withdraw from further sale all batches of GoResp Digihaler (budesonide and formoterol fumarate dihydrate) and the linked Digihaler App for commercial reasons.

Class 4 Medicines Defect Information: PHARMATHEN S.A., Grepid 75 mg film coated tablets (Kent Pharma Livery), EL(24)A/24. Issued 24 June. PHARMATHEN S.A. has informed the MHRA that the outer carton (box) of some batches of Grepid 75mg film coated tablets is missing the medicines legal classification for a Prescription Only Medicine POM. This notification contains additional batches impacted by this issue.

Article citation: Drug Safety Update volume 17, issue 12: July 2024: 2.