Medicines Healthcare Products Regulatory Agency
Letters
In August 2024, the following letters were sent or provided to relevant healthcare professionals:
Medicine Recalls and Notifications
In August 2024, recalls and notifications for medicines were issued on:
Class 4 Medicines Defect Information: Sandoz Limited, Omeprazole products, EL(24)A/34. Issued 7 August 2024. Sandoz Ltd. has informed the MHRA that there is missing safety information in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPCs) of the specific products listed in this notification.
Class 3 Medicines Recall: Accord-UK Ltd, Trandolapril 0.5mg, 2mg, 4mg Capsules, EL(24)A/35. Issued 8 August 2024. Accord-UK Ltd is recalling the listed batches after retesting showed out of specification results. The listed batches are being recalled as a precautionary measure after testing showed variability of the Trandolapril content beyond permitted levels.
Class 4 Medicines Notification, Star Pharmaceuticals Limited, Diflucan Oral Suspension 40mg/ml, EL(24)A36. Issued 12 August 2024. Star Pharmaceuticals Limited has informed the MHRA that an error has been identified in the Patient Information Leaflet (PIL) for two batches of Diflucan Oral Suspension 40mg/ml.
Class 4 Medicines Defect Information: Dawa Limited, Trazodone Hydrochloride 50mg, 100mg Capsules & 50mg/5ml Oral Solution, EL (24)A/37. Issued 14 August 2024. Dawa Limited has informed the MHRA of an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Trazodone Hydrochloride 50mg and 100mg Capsules and Trazodone Hydrochloride 50mg/5ml Oral Solution.
Class 2 Medicines Recall: Strides Pharma UK Limited, Loperamide Hydrochloride Capsules 2mg, EL(24)A/38. Issued 15 August 2024. Strides Pharma UK Ltd is recalling the listed batch as a precautionary measure due to an out of specification result for microbial contamination, reported during retesting.
Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd, Fingolimod 0.5 mg Hard Capsules, EL(24)A/39. Issued 19 August 2024. Glenmark Pharmaceuticals Europe Ltd is recalling this batch 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 4 Medicines Defect Information: Chemidex Pharma Ltd, Ponstan 250mg Capsules & 500mg Tablets (mefenamic acid), EL(24)A/40. Issued 27 August 2024. Chemidex pharma ltd has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batches listed in the tables for Ponstan 250mg capsules and Ponstan Forte 500mg tablets include an out of date PIL, dated March 2020 and January 2021 respectively.
Medical Device Safety Information
We recently published Device Safety Information pages on the following:
CPT Hip System Femoral Stem 12/14 Neck Taper: Increased Risk of Postoperative Periprosthetic Femoral Fracture, DSI/2024/007. Issued 4 September 2024. Recent research has found that the CPT Hip System Femoral Stem 12/14 Neck Taper, cobalt chromium, (a type of hip implant) carries a higher risk of postoperative periprosthetic femoral fracture (PFF) compared to hips of a similar design but made of a different material. The device will be phased out in the UK by December 2024. For additional information please refer to the Device Safety Information page and the Field Safety Notice.
Philips Respironics BiPAP A series ventilators: alarm malfunction and risk of therapy interruptions in ventilators not intended for life-support, DSI/2024/006. Issued 28 August 2024. Philips Respironics has issued a Field Safety Notice (FSN) relating to the Bilevel Positive Airway Pressure (BiPAP) A series ventilators. This relates to a Ventilator Inoperative alarm which could result in the potential loss of therapy to patients without warning. For additional information please refer to the Device Safety Information page and the Field Safety Notice.
Article citation: Drug Safety Update volume 18, issue 2: September 2024: 2.