Archive for MHRA Updates
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...
Suzhou Surgicare disposable Hysteroscopy Sheath– Recall due to withdrawn CE certificate, (DSI/2025/001)
Source: MHRA/Gov.uk 19.3.25 The MHRA has become aware of Hysteroscopy Sheaths supplied in the UK market with a withdrawn CE certificate. Healthcare professionals and providers should immediately stop use, quarantine,...
UPDATE: Class 4 Medicines Defect Notification: Azithromycin 250 mg Capsules, EL(25)A/11
Source: MHRA/Gov.uk 11.3.25 Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed is outdated. DMRC reference number DMRC-34866680 Marketing...
Class 4 Medicines Defect Notification: Azithromycin 250 mg Capsules, EL(25)A/11
Source: MHRA/ Gov.uk 11.3.25 Jubilant Pharmaceuticals NV has informed the MHRA that the Patient information leaflet (PIL) in the cartons for the batches listed in the table include an outdated...
Class 2 Medicines Recall: Boots Paracetamol 500 mg tablets (16s), EL(25)A/10
Source: MHRA/Gov.uk 4.3.25 Aspar Pharmaceuticals Limited have informed the MHRA of an error related to a batch of Boots Paracetamol 500 mg tablets (16s). The foil blister inside the carton...
Class 2 Medicines Recall: Sun Pharmaceutical Industries Europe B.V., Pemetrexed 1000MG/100ML (10mg/ml) & 800MG/ML (8mg/ml) Infusion bag, EL(25)A/09
Source: MHRA/Gov.uk 4.3.25 Sun Pharmaceutical Industries Europe B.V. is recalling those product batches listed in this notification as a precautionary measure due to out of specification results reported for the...
Class 3 Medicines Recall: Azacitidine 100 mg/vial and 150 mg/vial Powder for Suspension for Injection, EL(25)A/08
Source: MHRA/Gov.uk 3.3.25 Accord Healthcare Limited is recalling certain batches of Azacitidine Powder for Suspension for Injection 100 mg/vial and 150 mg/vial as precautionary measure due to out of specification...
Class 4 Medicines Notification: Lansoprazole Gastro-resistant Hard Capsules 15mg, EL(25)A/06
Source: MHRA/Gov.uk 11.2.25 Teva UK Limited is reporting a minor typographical error on the carton for Lansoprazole Gastro-Resistant Hard Capsules 15mg. There are two instances where the dosage form is...
Class 2 Medicines Recall: Nitrofurantoin CNX Therapeutics 100 mg Prolonged-Release capsules, EL(25)A/05
Source: MHRA/Gov.uk 5.2.25 CNX Therapeutics is recalling the batches listed in this notification as a precautionary measure due to a small number of packs that contain an additional tablet of...
