Archive for MHRA Updates
Company led medicines recall: Advanced Accelerator Applications NETSPOT (Kit for the preparation of gallium Ga 68 dotatate injection) [unlicensed medicine], CLMR (22)A/02
Source: MHRA / Gov.uk 16.3.22 Advanced Accelerator Applications is recalling specific batches of this product as a precautionary measure due to an out of specification result that was identified during...
Class 4 Medicines Defect Information, Ayrton Saunders Limited, Beclometasone dipropionate 50 micrograms/dose Nasal Spray (Various Liveries), EL (22)A/14
Source: MHRA/ Gov.uk 15.3.22 Ayrton Saunders Limited have identified an error relating to the Braille printed on the cartons. MDR Number MDR 087-03/22 Company name Ayrton Saunders Limited Product description...
Class 4 Medicines Defect Information: CNX Therapeutics Ltd, Latuda film-coated tablets, EL (22)A/13
Source: MHRA / Gov.uk 14.3.22 CNX Therapeutics Ltd. have notified the MHRA that the batches of Latuda film-coated tablets listed in this notification will be released without EAN barcodes on...
Class 4 Medicines Defect Information: Boots Company Plc, Decongestant Tablets and Decongestant with Pain Relief Tablets, EL (22)A/12
Source: MHRA / Gov.uk 10.3.22 Boots have identified an error with the printed patient information leaflet provided with batches of the Decongestant Tablets and Decongestant with Pain Relief Tablets. MDR...
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...
