Archive for MHRA Updates
Field Safety Notices: 3 to 7 January 2022
Source: MHRA / Gov.uk List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 January 2022 Overview If you receive a field safety notice (FSN) from...
Rheovalves disposable needle-free valves: stop using specific lots due to risk of breakage in patient. DSI/2021/010
Source: MHRA/ Gov.uk 20.12.21 Baihe Medical have identified an increase in complaints for Rheovalves disposable needle-free valves product code RVNF1. Devices from specific lots are affected. There is a risk...
Class 2 Medicines Recall: Wockhardt UK Ltd, Heparin sodium 1,000 I.U./ml solution for injection or concentrate for solution for infusion, EL (21)A/38
Source: MHRA Gov.uk 20.12.21 One batch is being recalled due to out of specification results due to a low bioassay result at the 24-month shelf life stability testing. MDR...
Class 4 Medicines Defect Information: SmofKabiven Central emulsion for Infusion, Fresenius Kabi Ltd, EL (21)A/37
Source: MHRA Gov.uk Fresenius Kabi Limited have identified an error on the infusion bag packaged in certain batches. MDR Number MDR 022-12/21 Company name Fresenius Kabi Limited Product description SmofKabiven...
Class 2 Medicines Recall: Novartis Pharmaceuticals UK, Lucentis 10 mg/ml solution for injection in pre-filled syringe EL (21)A/36
Source: MHRA Gov.uk Novartis Pharmaceuticals UK are recalling the above batch due to a faulty plunger stopper which has led to an increased number of customer complaints relating to the...
Class 2 Medicines Recall: Intrapharm Laboratories Ltd, Mydrilate 0.5% Eye Drops 5ml, EL (21)A/35
Source: MHRA Gov.uk 8.12.21 Intrapharm Laboratories Ltd are recalling the above batch of Mydrilate 0.5 % Eye Drops 5ml as a precautionary measure due to out of specification results for...
Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products, EL(21)A/34
Source: MHRA Gov.uk 1/12/21 Specific batches of products supplied by Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity. MDR Number MDR...
Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products, EL(21)A/34
Source: MHRA Gov.uk 30.11.21 Specific batches of products supplied by Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity. MDR Number MDR...
Class 4 Medicines Defect Information: Mometasone Furoate 50 Microgram / Dose Nasal Spray, Suspension, PilsCo Ltd, EL (21)A/33
Source: MHRA Gov.uk 29.11.21 Error relating to the wording on the outer carton label for Mometasone Furoate 50 Microgram / Dose Nasal Spray, supplied by PilsCo Ltd. MDR Number...
Class 4 Medicines Defect Information: Diuril Oral Solution (unlicensed medicine), Mawdsley-Brooks & Company Limited, EL (21)A/32
Source: MHRA Gov.uk 29.11.21 Error with the patient information leaflet (PIL) that has been provided with Diuril Oral Solution, supplied by Mawdsley-Brooks & Company Limited. MDR Number MDR 241-11/21 Company...
Handpieces used in the phacoemulsification technique of cataract removal: need for careful cleaning (DSI/2021/009)
Source: MHRA / Govb.uk 24.11.21 Residue particles can end up in the patient’s eye. For the attention of decontamination specialists, theatre practitioners and anyone involved with the cleaning and decontamination...
Class 3 Medicines Recall: Martindale Pharma, an Ethypharm Group Company Methadone 5mg Tablets / Physeptone 5mg Tablets, EL (21)A/31
Source: MHRA/ Gov.uk 22.11.21 Martindale Pharma is recalling the below batch of Methadone 5mg tablets as a precautionary measure due to the discolouration of the PVdC film in a small...
