Archive for MHRA Updates
Kimal Procedure Packs containing recalled components: Namic Angiographic Syringe with the risk of syringe disconnection; Namic Manifolds with the risk of foreign particulates. Important guidance for use in urgent procedures where there are no alternatives.
Updated 22.5.26 Source: MHRA 19.5.26 Medline Industries LP and Kimal PLC have identified safety issues with the Namic Angiographic Control Syringes with RA and Namic White Star Off Handle Manifold...
Risk of severe harm from use of incorrect giving (administration) set for blood transfusion (DSI/2026/003)
Source: MHRA 20.5.26 There is a potential for serious harm to patients if an intravenous (IV) infusion giving set is used instead of a blood transfusion giving set to deliver...
Class 4 Medicines Defect Notification: Fresenius Medical Care Deutschland GmbH, balance 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis, EL(26)A/24
Source: MHRA 15.5.26 Fresenius Medical Care Deutschland GmbH have identified an error in the Braille printed on the outer label. DMRC reference number DMRC – 39439934 Marketing Authorisation Holder Fresenius...
Class 4 Medicines Defect Notification: Milpharm Limited, Loperamide hydrochloride 2 mg Orodispersible Tablets, EL(26)A/23
Source: MHRA/Gov.uk 11.05.2026 Milpharm Limited has identified a discrepancy in the Patient Information Leaflet (PIL) approved for Loperamide hydrochloride 2 mg Orodispersible Tablets. DMRC reference number DMRC – 39394163 Marketing...
Class 2 Medicines Recall: Amarox Limited, Sertraline 100mg film-coated tablets, EL(26)A/22
Source: MHRA/Gov.uk 28.04.2026 Amarox Limited is recalling one batch of Sertraline 100 mg film-coated tablets as a precautionary measure due to an error at the manufacturing site. DMRC reference number...
Class 3 Medicines Recall: Omega Pharma Ltd, Napralief 250mg Gastro-Resistant Tablets, EL(26)A/21
Source: MHRA/Gov.uk 24.04.2026 Amended from 23.04.2026 Omega Pharma Ltd is recalling specific batches of Napralief 250mg Gastro-Resistant Tablets due to missing text in Section 2 and Section 3 of the...
Class 3 Medicines Recall: Omega Pharma Ltd, Napralief 250mg Gastro-Resistant Tablets, EL(26)A/21
Source: MHRA/Gov.uk 23.04.2026 Omega Pharma Ltd is recalling specific batches of Napralief 250mg Gastro-Resistant Tablets due to missing text in Section 2 and Section 3 of the Patient Information Leaflet...
Class 4 Medicines Defect Notification: Doncaster Pharma Limited, Hiprex 1g tablets, EL(26)A/20
Source: MHRA/Gov.uk 22.04.2026 Doncaster Pharma Limited has informed the MHRA of an error related to the Braille embossing on the outer packaging of certain parallel imported batches of Hiprex 1...
Class 2 Medicines Recall: Crescent Pharma Limited, Ramipril 10mg capsules, EL(26)A/19
Source: MHRA/Gov.uk 20.04.2026 Crescent Pharma Limited is recalling one batch of Ramipril 10mg Capsules as a precautionary measure due to a potential error at the manufacturing site. DMRC reference number...
Class 2 Medicines Recall: Bio Products Laboratory Limited, Rabies, Human normal Immunoglobulin 500IU solution for Injection, EL(26)A/18
Source: MHRA/Gov.uk 30.03.2026 Bio Products Laboratory Limited is recalling one batch of Human Rabies Immunoglobulin following a stability failure for this batch. The batch has shown a reduction in potency...
Class 4 Medicines Defect Notification: Sandoz Limited, Apixaban 2.5mg and 5mg Tablets, EL(26)A/17
Source: MHRA/Gov.uk 26.03.2026 Sandoz Ltd. have informed the MHRA that the Patient Information Leaflet included in specified batches of Apixaban does not contain up‑to‑date information. DMRC reference number DMRC-38614094 Marketing...
Class 4 Medicines Defect Notification: Quadrant Pharmaceuticals Limited, Vesomni 6 mg/0.4 mg modified release tablets , EL(26)A/16
Source: MHRA/Gov.uk 26.03.2026 Quadrant Pharmaceuticals Limited have informed the MHRA that their parallel imported packs of Vesomni 6 mg/0.4 mg modified release tablets have been printed with the incorrect barcode/GTIN...
