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.
Medicine recalls page 6
Medicine recalls, drug alerts and medical device warnings from the MHRA. 609 listed.
Strides Pharma UK Limited, Loperamide Hydrochloride Capsules 2mg
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 4 Medicines Defect Information: Dawa Limited, Trazodone Hydrochloride 50mg, 100mg Capsules & 50mg/5ml Oral Solution
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…
Class 4 Medicines Notification, Star Pharmaceuticals Limited, Diflucan Oral Suspension 40mg/ml, EL(24)A36
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.
Accord-UK Ltd, Trandolapril 0.5mg, 2mg, 4mg Capsules
Accord-UK Ltd is recalling the listed batches after retesting showed out of specification results.
Class 4 Medicines Defect Information: Sandoz Limited, Omeprazole products
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.
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.
Class 4 Medicines Defect Information: Aspen Pharma Trading Limited, Co-trimoxazole 80mg/400mg per 5ml adult suspension
Aspen Pharma Trading Limited has informed the MHRA that an error has been found in the Patient Information Leaflet.
Class 4 Medicines Defect Information: Fresenius Kabi Limited, Hartmann’s Solution for Injection BP as Steriflex No. 11 or freeflex
Fresenius Kabi Limited has informed the MHRA of a labelling error on the packaging of Hartmann’s solution for Injection BP as Steriflex No.11 or freeflex.
Glaxo Wellcome UK Limited (trading as GlaxoSmithKline UK), Flolan 1.5 mg Powder and Solvent for Solution for Infusion
Glaxo Wellcome UK Ltd (GSK) has informed the MHRA that vials of Flolan 1.5 mg Powder and Solvent for Solution for Infusion, batch number AB8M may have been damaged during the packaging process.
Sun Pharma UK Limited, Pemetrexed 1000MG/100ML (10mg/ml) & 1100MG/100ML (11mg/ml) Infusion Bag
Sun Pharmaceutical Industries Europe B.V. is recalling the listed batches as a precautionary measure due to visible particulate matter during stability testing.
Sun Pharma UK Limited, Gemcitabine PPF 1800mg/180mL Infusion; Gemcitabine PPF 1600mg/160mL Infusion; Irinotecan PPF 360mg/240mL Infusion
Sun Pharma UK Ltd is recalling certain batches as a precautionary measure due to a small number of leaks found intermittently in the infusion bags.
Class 4 Medicines Defect Information: Chelonia Healthcare Limited, Propantheline Tablets 15mg (Genesis Pharmaceuticals livery)
Chelonia Healthcare Limited has informed the MHRA that an error relating to the product description was identified in the Patient Information Leaflet (PIL) for the batches listed in this notification.
Kent Pharma UK, Itraconazole 10mg/ml Oral Solution
Kent Pharma UK is recalling various batches of Itraconazole 10mg/ml Oral Solution as a precautionary measure due to out of specification in the appearance of the solution, particularly the presence of suspended particles or…
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…
Class 4 Medicines Defect Information: PHARMATHEN S.A., Grepid 75 mg film coated tablets (Kent Pharma Livery)
PHARMATHEN S.A. has informed the MHRA that the outer carton (box) of some batches of Grepid 75mg film coated tablets is missing the medicines legal classification for a Prescription Only Medicine ‘POM.’ This notification…
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.
Class 4 Medicines Defect Information: Viatris UK Healthcare Ltd, Oxcarbazepine Mylan 150 mg, 300mg, 600mg Film-Coated Tablets
Viatris UK Healthcare Limited has informed the MHRA that the Patient Information Leaflet (PIL) packaged in the specified batches of Oxcarbazepine 150 mg, 300 mg & 600 mg Film-Coated Tablets do not contain the…
Class 4 Medicines Defect Information: Dawa Limited, Paracetamol 500mg, 1000mg Film-Coated Tablets
Dawa Limited has informed the MHRA that specified batches listed in this notification have been packed with an outdated Patient Information Leaflet (PIL).
Desitin Pharma UK Ltd, Lamotrigine Desitin 10mg/ml Oral Suspension
Desitin Pharma UK Ltd is recalling all batches of Lamotrigine Desitin 10mg/ml Oral Suspension as a precautionary measure due to an out of specification observation in the appearance of samples during routine stability testing.…
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 4 Medicines Defect Information: Manx Healthcare Ltd., Betamethasone Valerate 0.1% Ointment
Manx Healthcare Ltd. has informed MHRA that they have identified a problem with the product packaging of the batch indicated in the table.
Class 4 Medicines Defect Information: Fresenius Kabi Limited, Sodium Chloride 0.9% Intravenous Infusion BP (Freeflex and Freeflex Plus)
Fresenius Kabi Limited have informed the MHRA of a packaging error with specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex and Freeflex PLUS.
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…