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Drugsrus Limited has informed the MHRA that a small number of bottles of Metronidazole 200 mg/5 ml Oral Suspension 100ml are leaking from the cap.
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Actions to be taken to avoid potential unexpected shutdown leading to complete loss of ventilation
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Manufactured by Medtronic – battery voltage may reduce to a point where the device is no longer able to provide patient pacing therapy - MDA/2015/038
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Philips Respironics has issued a Field Safety Notice (FSN) relating to the Bilevel Positive Airway Pressure (BiPAP) A series ventilators. This relates to a Ventilator Inoperative alarm which could result in the potential los…
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Novo Nordisk Limited would like to notify you of a defect that affects specific batches of NovoRapid FlexTouch prefilled pen device and batches of Saxenda FlexTouch prefilled pen device in the UK.
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(Boston Scientific) Rapid battery depletion leads to risk of loss of therapy. (MDA/2014/039)
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(Hospira) Due to insulation abrasion. (MDA/2013/007)
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Qualasept Ltd t/a Bath ASU is recalling a specific batch of Irinotecan 200mg/260mL in sodium chloride 0.9% w/v intravenous infusion and specific batches of Infliximab (Remsima) Intravenous infusion in Sodium Chloride 0.9%w/v…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 July 2022.
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The MHRA has notified Bausch and Lomb UK Limited of reports that Emerade pens have failed to activate. The MHRA is advising that Emerade devices should not be recalled.
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…Manufactured by Roche Diabetes Care – Replacement and update to MDA/2015/029 with new instructions to improve battery lifetime and prevent unexpected pump shut down or rapid battery depletion.…
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List of Field Safety Notices (FSNs) from 20 to 24 November 2023
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…(All) adverse outcomes are still reported when CTG traces appear normal - this replaces alert SN 2002(23) issued August 2002. (MDA/2010/054)…
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Manufactured by ArjoHuntleigh AB – spreader bar may detach from the lift arm during patient transfer with the potential for serious injuries to the patient.
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(Allergan UK Limited) Specific batch including a Danish language pack was shipped to the UK in error. Class 3 – action within 5 days. (EL (15)A/03)
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Takeda UK Limited is recalling a batch of Instanyl 100mcg nasal spray solution (EU/1/09/531/015) due to the observation of cracked vials during inspection of the bulk vials and release testing of the finished products.
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Advanced Accelerator Applications (UK & Ireland) Ltd is recalling a specific batch as it was identified during the inspection process by the manufacturer that a small number of bags were observed to be leaking.
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Allergan Pharmaceuticals Ireland is further recalling batches due to the possibility that a single loose silicone particle of approximately 300 microns in diameter may become detached.
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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 devices and bed grab handles.
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Manufactured by Philips – devices may lose power earlier than expected and users may not realise the loss of monitoring due to no alarm, which could contribute to a delay in emergency treatment.
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All anaesthesia machines with ventilators - using the anaesthesia device in treatment of critical illness, outside its intended use is considered off-label use but may be essential due to ventilator availability.
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Ecolab are recalling batches of Klerpack BD Syringe Multi-Pack as the sterile packaging may contain small holes in the film of the pouch. (EL (16)A/13)
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(Special Products Ltd) A batch of Epistatus 10mg in 1ml Oromucosal Solution is being recalled due to the wrong size of neck adaptor in some bottles (EL (16)A/06)
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Action within 48 hours: Novo Nordisk Ltd. is recalling seven batches of GlucaGen HypoKit due to a small number of needles being detached from the syringe.
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East Suffolk and North Essex NHS Foundation Trust (MS 12882) is recalling specific batches of Glucose 10%w/v injection 10mL and Trometamol 7%w/v injection 5mL due to limited assurance of product sterility.
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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 product specification
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Becton Dickinson (BD) is recalling all ethylene oxide (EtO) sterilised BD Venflon Pro Safety (VPS) and Venflon Pro IV Cannulae after identifying an increase in reports of leakage from the injection port.
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Glaxo Wellcome UK Ltd (GSK) has informed the MHRA that vials of Flolan 1.5 mg Powder and Solvent for Solution for Infusion, batch number AB8M may have been damaged during the packaging process.
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Caution in Use: Distribute to Pharmacy and Clinic Level.
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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 (API) being present on the surface of the tablets as a…
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Error with the patient information leaflet (PIL) that has been provided with Diuril Oral Solution, supplied by Mawdsley-Brooks & Company Limited.
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(Hospira UK Limited) Visually inspect vials for particulate matter prior to use and do not use if crystals are found - Class 4 medicines defect information (EL (13)A/09)
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PCCA Limited have been made aware of an issue with the appearance of Ketamine 50mg in 5ml Oral Solution and Ketamine 100mg in 5ml Oral Solution.
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LEO Laboratories Ltd (T/A LEO Pharma) is recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to concerns on the possible risk of skin malignancy.
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UCB Pharma Ltd is recalling one batch of Dioctyl 100 mg Capsules as a precautionary measure due to the presence of a foreign capsule being found in a sealed pack.
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(Sorin) Difference between predicted and actual pacemaker battery depletion characteristics. (MDA/2013/084)
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(ratiopharm GmbH) Corrected batch numbers from EL (13)A/04 –class 3 action within 5 days. (EL (13)A/04 Rev 1)
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(Pfizer Limited) Very small number of ampoules containing glass particles identified – class 3 action within 5 days. (EL (13)A/14)
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Napp Pharmaceuticals Limited have noticed and an error in the PIL of specific batches of Sevredol 10 mg Tablets and Sevredol 20 mg Tablets.
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(Novo Nordisk A/S) Patients who may have received the affected batches should be contacted and asked to check their supply – class 2 action within 48 hours. (EL (13)A/25)
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hameln pharma ltd is initiating a recall of batch 210505 of Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion as a precautionary measure
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(Novartis Vaccines and Diagnostics GmbH) Potential problem with packaging of the syringes supplied with specific batches of Rabipur – class 4 caution in use. (EL (12)A/13)
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List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 August 2015.
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Galderma UK identified an error regarding an older version of artwork being used and packed with specific batches of Tetralysal 300mg Hard Capsules.
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hameln pharma ltd is initiating a recall of batch 207506 of Amiodarone Hydrochloride 50 mg/ml Concentrate for Solution for Injection/Infusion as a precautionary measure.
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…[Archived] Manufactured by CareFusion – Updates and replaces MDA/2016/023 as the manufacturer has now identified the potential for unintended bolus of medication when any syringe type is used in a pump that contains a broken spring in the plunger assembly.…
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Pfizer Ltd are recalling all in-date batches of Champix (varenicline) as a precautionary measure due to presence of levels of N-nitroso-varenicline above the acceptable level of intake. This recall also includes Parallel Imp…
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Pharmaswiss Česka republika s.r.o. is initiating an urgent recall of all batches of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors.
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Class 2 Medicines recall: UCB Pharma Limited are voluntarily recalling Viridal Duo Powder and Solvent for Injection (10mcg/ml and 40mcg/ml)
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The MHRA has been made aware that falsified medical oxygen has been provided to several dental practices across the UK.