Letters and medicine recalls sent to healthcare professionals in January 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: 20 February 2024

• Therapeutic area: Anaesthesia and intensive care, Cancer, Cardiovascular disease and lipidology, Dentistry and Dermatology
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  Ear, nose and throat, Endocrinology, diabetology and metabolism, GI, hepatology and pancreatic disorders, Haematology, Immunology and vaccination, Immunosuppression and transplantation, Neurology, Nutrition and dietetics, Obstetrics, gynaecology and fertility, Ophthalmology, Paediatrics and neonatology, Psychiatry, Respiratory disease and allergy, Rheumatology, and Urology and nephrology

Letters

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

• Oral valproate-containing medicines: Restriction of indication for male and female patients aged under 55 years; use revised educational materials
• Omega-3-acid ethyl ester medicines (Omacor/Teromeg 1000 mg capsules): dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors
• Lagevrio® (molnupiravir) 200 mg hard capsules ▼ – Extended Use Beyond Labelled Expiry Date
• Artiss 2ml Fibrin Sealant [Human] (product code: 5500649): Interim supply of Nordic Stock (Norway/Denmark) to Mitigate Supply Disruption
• EXKIVITY▼ (mobocertinib) 40 mg hard capsules – Conditional Marketing Authorisation Withdrawal
• Veltassa 16.8 g powder for oral suspension (Patiromer): Interim Supply of Northern Ireland Stock to Mitigate Supply Disruption
• ADAKVEO (crizanlizumab) ▼: revocation of UK marketing authorisation due to lack of therapeutic efficacy as determined by MHRA
• Plasma-Lyte 148 and Glucose 5% w/v Discolouration
• Tostran (Testosterone, 2% gel): priming instructions in the current PIL require updating
• Tamiflu® (oseltamivir) 45 mg Hard Capsules: Different colour ink used on blister pack

Medicine Recalls and Notifications

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

Class 4 Medicines Defect Information: Quadrant Pharmaceuticals Ltd, Cozaar 100mg film-coated tablets, EL(24)A/01. Issued: 4 January 2024. Quadrant Pharmaceuticals Ltd has informed the MHRA of an error with the Patient Information Leaflets (PILs) in the listed batches of Cozaar 100mg film-coated tablets. The PIL does not include the most up to date safety information. In Section 2 ‘What you need to know before you take Cozaar’, sub section ‘Cozaar with food and drink’ the following information is missing: ‘Grapefruit juice should be avoided while taking Cozaar.’

Class 4 Medicines Defect Information: USV UK Limited, Sugammadex 100 mg/ml solution for injection (2 ml vial), EL(24)A/02. Issued: 18 January 2024. USV UK Limited has informed the MHRA that Sugammadex 100 mg/ml solution for injection (2 ml vial), batch number 35000347, may contain some vials that contain a low volume of solution; less than the label claim of 2 ml. Additional vials may need to be used to supplement the required dosage in line with the requirement of individual patient treatment.

Class 4 Medicines Defect Information: Cadila Pharmaceuticals (UK) Limited, Pantoprazole 40 mg Gastro-Resistant Tablets, EL (24)A/03. Issued: 30 January 2024. Crescent Pharma Limited has informed the MHRA regarding an error with the European Article Number (EAN) barcode on the cartons of the above-mentioned batches of Pantoprazole 40 mg Gastro-Resistant Tablets distributed by Crescent Pharma Limited. When scanned, the EAN barcode identifies the product as Bicalutamide 150 mg Tablets. Do not use these batches of medicine in robotic or automated dispensing or stocking systems and carry out manual dispensing and stocking, as appropriate.

Article citation: Drug Safety Update volume 17, issue 7: February 2024: 3

Published 20 February 2024