Archive for MHRA Updates
Class 4 Medicines Defect Notification: Dulcolax Adult 5 mg Gastro-resistant Tablets, Opella Healthcare UK, EL(25)A/26
Source: MHRA/ Gov.uk 10.6.25 Opella Healthcare UK LTD has informed the MHRA that there is an error on the artwork for the outer carton of Dulcolax Adult 5mg GR Tablets...
Class 2 Medicines Recall: Paracetamol 500mg Tablets, Chelonia Healthcare Limited, EL(25)A/25
Source: MHRA/Gov.uk 9.6.25 Chelonia Healthcare Limited is recalling specific batches of Paracetamol 500mg Tablets (100 pots) as a precautionary measure due to contamination following a small number of complaints of...
Class 4 Medicines Notification, Zentiva Pharma UK Limited, Various Products, EL(25)A/24
Source: MHRA/Gov.uk 2.6.25 Zentiva Pharma UK Limited has informed the MHRA of an issue related to batches of various soluble or effervescent tablets. DMRC reference number DMRC-35524103 Marketing Authorisation Holder...
Class 4 Medicines Notification, Chemidex Pharma Ltd, Various Products, EL(25)A/21
Source: MHRA / Gov.uk 13.5.25 Chemidex Pharma Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in their topical steroid products does not contain all the required safety...
Class 4 Medicines Defect Notification: Chloramphenicol 1% w/w Eye Ointment, Blumont Pharma Limited, EL(25)A/20
Source: MHRA / Gov.uk 8.5.25 Blumont Pharma Limited has informed the MHRA of an error with the European Article Number (EAN) barcode on the cartons of the batch of Chloramphenicol...
Class 4 Medicines Defect Notification: Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg Capsules, Jubilant Pharmaceuticals NV, EL(25)A/19
Source: MHRA/Gov.uk 29.4.25 Jubilant Pharmaceuticals BV has informed the MHRA that the outer carton (box) of the product batches mentioned in this notification are missing the medicines legal classification for...
Class 4 Medicines Defect Notification: Brilique 90mg Tablets, EL(25)A/18
Source: Gov.uk / MHRA 24.4.25 G Pharma Ltd have informed the MHRA that there is an error in the spelling of the active ingredient included on the imported carton. The...
Class 2 Medicines Recall: Lercanidipine HCl 20mg Tablets, Recordati Industria, EL(25)A/17
Source: MHRA Recordati Pharmaceuticals Limited has informed the MHRA of an error in the strength of the product printed on some of the faces (sides) of the product carton. The...
Class 2 Medicines Recall: Synalar GEL 30g, Synalar GEL 60g,(fluocinoline acetonide 0.025%) Reig Jofre UK,EL(25)A/16
Source: MHRA/ Gov.uk 8.4.25 It has been identified that the batches of Synalar Gel 30g and 60g listed in this notification contain a residual solvent (benzene) at a level exceeding...
Class 3 Medicines Recall: Urospir 50mg/5ml Oral Solution, EL(25)A/14
Source: MHRA/Gov.uk 31.3.25 Rosemont Pharmaceuticals Limited is recalling a single batch of Urospir 50mg/5ml Oral Solution (spironolactone) as a precautionary measure. The recall is due to errors in some of...
Class 2 Medicines Recall: Utrogestan Vaginal 200 mg Capsules (progesterone), EL(25)A/13
Source: MHRA/Gov.uk 1.4.25 Uni Health Distribution Ltd has informed the MHRA of a typographical error on the approved carton overlabel for certain batches of Utrogestan Vaginal 200 mg Capsules. The...
Class 4 Medicines Defect Notification: Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension, EL(25)A/12
Source: MHRA/Gov.uk 31.3.25 Cross Healthcare Limited have informed the MHRA that there is a printing defect on the outer labels for the Sirdupla 25 microgram/250 microgram per metered dose pressurised...
