Archive for MHRA Updates
Class 4 Medicines Defect Information: Sandoz Limited, Zinacef powder for solution for injection or infusion vials (all strengths, including stock in GSK livery), EL (23)A/38
Source: MHRA/Gov.uk 23.10.23 Sandoz has detected that information on the diluents in the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC) of cefuroxime contain incorrect information. MDR number...
Falsified Ozempic (semaglutide) pens identified at two wholesalers in the UK
Source: MHRA 18.10.23 No evidence of supply or harm to patients The Medicines and Healthcare products Regulatory Agency (MHRA) has today (18 October 2023) confirmed that pre-filled pens falsely labelled...
SteriFeed Colostrum Collection device and risk of choking due to infant airway occlusion, DSI/2023/010
Source: MHRA/Gov.uk 10.10.23 The SteriFeed colostrum collection device is intended to be used only to collect and store colostrum. It should not be used as an infant feeding device as...
Class 4 Medicines Defect Information: Max Remedies Ltd, Max Healthcare Paracetamol 500 mg Capsules, EL (23)A/37
Source: MHRA /Gov.uk 27.9.23 Max Remedies has identified an infrequent printing error relating to the Braille text printed on the cartons of various batches of this product. MDR number MDR...
Class 3 Medicines Recall: Chiesi Ltd., Trimbow 87/5/9 mcg pressurised inhalation solution, EL(23)A/36
Source: MHRA/ Gov.uk 20.9.23 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...
Class 4 Medicines Defect Information: Colgate-Palmolive (U.K.) Limited, Duraphat 5000ppm Fluoride Toothpaste (51g), EL (23)A/35
Source: MHRA/Gov.uk 7.9.23 Colgate-Palmolive (U.K.) Limited has informed the MHRA that the Patient Information Leaflet (PIL), carton and tube of the batches of Duraphat 5000ppm Fluoride Toothpaste (51g) listed above...
Class 3 Medicines Recall: Theramex HQ UK Ltd, Evorel Sequi, EL (23)A/34
Source: MHRA/Gov.uk 6.9.23 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...
Class 4 Medicines Defect Information: Kyowa Kirin Limited, Tostran (Testosterone, 2% gel), EL (23)A/33
Source: MHRA /Gov.uk 31.8.23 Kyowa Kirin Limited has notified MHRA that the priming instructions in the current PIL for Tostran 2% gel require updating. MDR number MDR 013-08/23 Company name...
Class 2 Medicines Recall: Veriton Pharma Limited, Epistatus 2.5 mg oromucosal solution, pre-filled syringe (PFS), EL(23)A/32
Source: MHRA /Gov.uk 30.8.23 Veriton Pharma Limited is recalling a specific batch of Epistatus (midazolam) 2.5mg Oromucosal Solution (pre-filled oral syringes) due to confirmed out of specification results related to...
National Patient Safety Alert: Medical beds, trolleys, bed rails, bed grab handles and lateral turning devices: risk of death from entrapment or falls (NatPSA/2023/010/MHRA)
Source: MHRA /Gov.uk 30.8.23 The MHRA continues to receive reports of deaths and serious injuries from entrapment or falls relating to medical beds, bed rails, trolleys, bariatric beds, lateral turning...
Class 4 Medicines Defect Information: Galderma (U.K.) Limited, Loceryl 5% w/v Medicated Nail Lacquer (5.0 ml), EL (23)A/31
Source: MHRA/ Gov.uk 29.8.23 Galderma (U.K.) Limited has informed the MHRA that a pallet of Loceryl 5% w/v Medicated Nail Lacquer from a batch licensed only for distribution in Ireland...
Class 4 Medicines Notification, Accord Healthcare Limited, UK, Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion, EL (23)A/30
Source: MHRA /Gov.uk 23.8.23 Accord Healthcare Ltd, UK has informed the MHRA about an error with the Patient Information Leaflets (PILs) that have been packaged in the batches of these...
