Archive for MHRA Updates
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...
EyeCee One and EyeCee One Crystal preloaded intraocular lenses (IOLs): update of previous quarantine advice after identification of likely cause, DSI/2023/007
Source: MHRA/Gov.uk 3.8.23 The MHRA is providing an update on the issue of increased intraocular pressure in patients implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses....
Class 2 Medicines Recall: medac GmbH (t/a medac Pharma LLP), Sodiofolin 50 mg/ml solution for injection/infusion (400mg/8ml vial), EL (23)A/26
Source: MHRA /Gov.uk 20.7.23 medac GmbH (t/a medac Pharma LLP) is recalling the products and respective batches in this notification due to particles detected during long-term stability tests. MDR number...
Company led medicines recall: Quantum Pharmaceutical, Diltiazem HCl 2% Cream [unlicensed medicine], CLMR (23)A/05
Source: MHRA/Gov.uk 19.7.23 The company has informed us that the consistency of the product within the batches has a reduced viscosity and more closely resembles a lotion than a cream....
