Archive for MHRA Updates
Class 2 Medicines Recall: Wockhardt UK Ltd, Diazepam RecTubes 2.5mg Rectal Solution, EL (22)A/11
Soucre: MHRA / Gov.uk 8.2.22 Wockhardt UK Ltd are recalling a batch of Diazepam RecTubes 2.5mg Rectal Solution due to an out of specification result for assay during routine stability...
Class 3 Medicines Recall: Kyowa Kirin Services Ltd. Isotard 60mg XL Tablets, EL (22)A/10
Source: MHRA / Gov.uk 2.3.22 Kyowa Kirin Services Ltd. are recalling a batch of Isotard 60mg XL Tablets as a precautionary measure due to microfibres/crystals of the Active Pharmaceutical Ingredient...
UPDATE: Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Naprosyn Tablets (all strengths), Naprosyn EC 250mg Gastro-Resistant Tablets, Naprosyn EC 500mg Gastro-Resistant Tablets, EL (22)A/09
Source: MHRA Gov.uk 28.2.22 Atnahs Pharma UK Limited have identified additional missing information on the PIL of the certain product batches. MDR Number MDR 005-01/22 Company name Atnahs Pharma UK...
February 2022- Price Concessions Third Update
Source: DHSC/ NHSBSA Drug Tariff News – February Part VIIIA reimbursement prices (issued 25 February) The Department of Health and Social Care has agreed the February Drug Tariff Part VIIIA reimbursement prices for...
Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Naprosyn Tablets (all strengths), Naprosyn EC 500mg Gastro-Resistant Tablets, EL (22)A/09
Source: MHRA / Gov.uk 23.2.22 Atnahs Pharma UK Limited have identified additional missing information on the PIL of the certain product batches. MDR Number MDR 005-01/22 Company name Atnahs Pharma...
Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Fluorouracil Injection, 50 mg/ml, solution for injection (2500mg/50ml vial), EL (22)A 08
Source: MHRA Gov.uk 18.2.22 medac GmbH (t/a medac Pharma LLP) are recalling certain product batches as a precautionary measure due to visual detection of glass lamellae particles during an ongoing...
Surdial X Haemodialysis machine: potential for devices to remove excess fluid outside of machine specification. DSI/2022/002
Source: MHRA Gov.uk 18.2.22 The MHRA are aware of instances of Surdial X machines removing excess fluid via ultrafiltration outside of its specification. There is a risk to patients who...
Stop using Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths from Gemini Surgical UK: all lots and batches. DSI/2022/001
Source: MHRA Gov.uk 18.2.22 The MHRA has become aware that Vaginal Speculums with smoke tube and Gynaecological Hysteroscopy sheaths from Gemini Surgical UK are being sold with a falsely applied...
Class 2 Medicines Recall: Uni Health Distribution, Efudix 5% w/w cream, EL (22)A 07
Source: MHRA Gov.uk 17.2.22 Uni Health Distribution is aware of a potential issue where the leaflet contained within Efudix 5% w/w cream (2 x 20g) pack, batch 80193439/B may be...
Class 2 Medicines Recall: hameln pharma ltd, Water for Injections BP – 100ml vial, EL (22)A 06
Source: MHRA Gov.uk 13.2.22 hameln pharma ltd is recalling a batch of a product as a precautionary measure as remaining vials may no longer be in line with the licensed...
Class 4 Medicines Defect Information: Atnahs Pharma UK Limited, Naprosyn Tablets (all strengths), Naprosyn EC 250mg Gastro-Resistant Tablets, EL (22)A/05
Source: MHRA/ Gov.uk 3.2.22 Atnahs Pharma UK Limited have identified missing information on the PIL of the above batches. MDR Number MDR 005-01/22 Company name Atnahs Pharma UK Limited Product...
Final Update-January 2022 Price Concessions
Source: DHSC /NHSBSA Drug Tariff News – January Part VIIIA reimbursement prices (issued 2 February) The Department of Health and Social Care has agreed the January Drug Tariff Part VIIIA reimbursement prices for...