Orion Pharma (UK) Ltd, Eldepryl 5mg Tablets (selegiline)
Orion Pharma (UK) Ltd is recalling this batch as a precautionary measure due to an out of specification result in the assay result during the follow up stability study of the batch.
Class 3 medicine recalls recalls page 2
All UK Class 3 medicine recalls recalls and safety alerts, newest first, with the hazard, affected models and what to do next. 70 listed.
Theramex HQ UK Ltd, Evorel Sequi
Theramex has informed the MHRA that some cartons of Evorel Sequi contain the incorrect combination of patches. An error at the packaging site means that a limited number of packs have the incorrect combination…
Glenmark Pharmaceuticals Europe Ltd, Fingolimod 0.5 mg Hard Capsules
Glenmark Pharmaceuticals Europe Ltd is recalling this batch after retesting showed out of specification results.
Accord-UK Ltd, Trandolapril 0.5mg, 2mg, 4mg Capsules
Accord-UK Ltd is recalling the listed batches after retesting showed out of specification results.
Glenmark Pharmaceuticals Europe Ltd, Atomoxetine 10mg, 18mg, 25mg, 10mg, 40mg, 60mg, 80mg & 100mg Hard Capsules
Glenmark Pharmaceuticals Europe Ltd is recalling various batches after retesting showed out of specification results.
Accord Healthcare Ltd, Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules
Accord Healthcare Ltd is recalling various batches 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…
Teva UK Limited, GoResp Digihaler
Teva UK Limited has informed the MHRA that it plans to withdraw from further sale all batches of GoResp Digihaler (budesonide and formoterol fumarate dihydrate) and the linked Digihaler App for commercial reasons.
Neuraxpharm UK Ltd, Atomoxetine 10mg, 18mg, 25mg, 40mg Capsules
Neuraxpharm UK Ltd is recalling specific batches 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…
Class 3 Medicines Defect Information: Doncaster Pharma Limited, Keppra 500mg film-coated tablets
The MHRA has re-issued this notification as Class 3 recall based on further assessment. Please note the new actions for healthcare professionals listed within the notification. Doncaster Pharma Limited have identified an error relating…
Neon Healthcare Ltd, Suprefact 1 mg/ml solution for injection (Cheplapharm – Canadian Livery)
Neon Healthcare Ltd is recalling the specific batch mentioned in this notification as a precautionary measure.
A. Menarini Farmaceutica Internazionale Srl, Invokana 300mg tablets (Northern Ireland only)
A. Menarini Farmaceutica Internazionale Srl is recalling a specific batch as a precautionary measure due to the distribution of Invokana 300mg in Northern Ireland in packaging intended for the Greek market.
Accord-UK Ltd, Co-Codamol 8/500mg Effervescent Tablets (Key Pharmaceuticals Livery)
Accord-UK Ltd is recalling a specific batch of Co-Codamol 8/500mg Effervescent Tablets (Key Pharmaceuticals Livery) as a precautionary measure due to the internal tablet blister strips being printed with an incorrect expiry date.
Bristol-Myers Squibb Pharmaceuticals Limited, OPDIVO 10 mg/mL concentrate for solution for infusion (nivolumab)
Bristol-Myers Squibb Pharmaceuticals Limited has informed the MHRA that a potential product quality issue has been detected, relating to incomplete crimping of the metal crimp cap of OPDIVO 10mg/mL concentrate for solution for infusion…
Besins Healthcare (UK) Ltd, Oestrogel Pump-Pack 750 micrograms/actuation Gel (estradiol)
Besins Healthcare (UK) Ltd has informed the MHRA that a defective pump system was detected in two batches of Oestrogel Pump-Pack 750 micrograms/actuation Gel.
Torrent Pharma (UK) Limited, Ramipril 1.25mg tablets
Torrent Pharma (UK) Limited is recalling certain batches of Ramipril 1.25mg tablets as a precautionary measure due to these batches having a low assay and high related substances test results after their release to…
Biocon Pharma UK Ltd., Posaconazole Biocon 100mg Gastro-resistant Tablets
Biocon Pharma UK Limited are recalling a specific of batch Posaconazole 100mg Gastro-resistant Tablets due to an out of trend result for unspecified impurities during testing for stability.
AstraZeneca UK Ltd., Fluenz Tetra nasal spray suspension
AstraZeneca UK Ltd. has informed the MHRA of an issue related to the expiry dates for certain batches of Fluenz Tetra. This recall provides further advice on the safe use of the product up…
Chiesi Ltd., Trimbow 87/5/9 mcg pressurised inhalation solution
Chiesi Ltd has informed the MHRA about a potential issue with the batches listed in this notification. This is due to intermittent high results for the uniformity of delivered dose of formoterol fumarate observed…
Theramex HQ UK Ltd, Evorel Sequi
Theramex has informed the MHRA that some cartons of Evorel Sequi contain the incorrect combination of patches. An error at the packaging site means that a limited number of packs have the incorrect combination…
Strandhaven Limited T/A Somex Pharma, Sildenafil 100mg Film-coated Tablets
Strandhaven Limited T/A Somex Pharma has informed the MHRA that the pack size on some cartons of the batch in this notification state 8 tablets instead of 4 tablets.
Tricodent Limited (supplier), Medical Oxygen B.P (MEDIGAS OXYGEN B.P)
The MHRA has been made aware that falsified medical oxygen has been provided to several dental practices across the UK.
Hikma Farmacêutica Portugal S.A., Gemcitabine 1g/26.3ml & 2g/52.6ml Solution For Infusion Vial
Hikma Farmacêutica Portugal S.A has informed the MHRA of a potential issue impacting the batches listed in this notification.
Rosemont Pharmaceuticals Limited, Sildenafil 10mg/ml Oral Suspension
Rosemont Pharmaceuticals Limited has informed the MHRA that the Press In Bottle Adaptor (PIBA) supplied with the pack (carton) of a specific batch is too wide to fit the neck of the medicine bottle.
Dr Reddy’s Laboratories (UK) Ltd, Lacidipine 4 mg Film-Coated Tablets
Dr Reddy’s Laboratories (UK) Limited is recalling two batches of Lacidipine 4 mg Film-Coated Tablets as a precautionary measure due to the presence of an unknown solvent-like odour.