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Field Safety Notice: 19 to 23 October
List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 October 2020.
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Company led drug alert - Optiray® 300mg I/ml Solution for Injection or Infusion (PL 12308/0028) and Optiray® 350mg I/ml Solution for Injection or Infusion (PL 12308/0032)
Guerbet Laboratories Limited is recalling certain batches of products as a precautionary measure due to reports received from healthcare professionals on the difficulties in attaching the Luer lock adapter to the Luer tip of…
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Field Safety Notice: 12 to 16 October
List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 October 2020.
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Medical Devices Safety Bulletin (MDSB/2020/01)
This is a new regular bulletin from Medicines and Healthcare products Regulatory Agency (MHRA) to inform health and care professionals of new or ongoing safety issues with medical devices.
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Class 3 Medicines Recall: Metoprolol 50 mg Tablets (PL 20075/0304), EL (20)A/49
Accord Healthcare Ltd has informed us that when decommissioning at the pharmacy and scanning the serialised 2D code, the status of certain packs may report as ‘EXPORT.’
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Class 2 Medicines Recall: Sanofi Epilim 500mg Gastro-Resistant Tablets EL (20)A/48*
Sanofi is recalling batches of product as a precautionary measure due to out of specification results for disintegration test during routine stability testing.
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Field Safety Notices: 5 to 9 October 2020
List of field safety notices (FSNs) from medical device manufacturers from 5 October to 9 October 2020
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Class 2 Medicines Recall: Boots Dermacare 1% w/w Hydrocortisone Ointment (Batch 1DD), EL (20)A/47
The Boots Company PLC is recalling a specific batch of Hydrocortisone 1% w/w Ointment as a precautionary measure due to retained samples showing presence of Pseudomonas aeruginosa.
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Field Safety Notices: 28 September to 02 October 2020
List of field safety notices (FSNs) from medical device manufacturers from 28 September to 02 October 2020
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Class 3 Medicines Recall: Theramex Ireland Ltd T/A Theramex HQ UK Ltd, AlfaD Capsules, EL (20) A/46
Theramex Ireland Ltd T/A Theramex HQ UK Ltd has informed us that when decommissioning at the pharmacy and when scanning the serialised 2D code, the status of certain packs of AlfaD capsules may report as ‘EXPORT’
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Field Safety Notice: 21 to 26 September 2020
List of field safety notices (FSNs) from medical device manufacturers from 21 to 26 September 2020
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Field Safety Notice: 12 to 16 August 2019
List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 August 2019.
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National Patient Safety Alert: Philips Respironics V60 ventilator - unexpected shutdown (NatPSA/2020/007/MHRA)
Actions to be taken to avoid potential unexpected shutdown leading to complete loss of ventilation
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Field Safety Notices: 14 to 18 September 2020
List of Field Safety Notices (FSNs) from medical device manufacturers from 14 September to 18 September 2020
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Class 2 FMD Medicines Recall, Parallel Distributed Medicines, Multiple Products, EL (20)A/45
Medicines from the listed parallel distributors are being recalled due to concerns that the supply chain may have been compromised and the origins of the products are unknown
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Field Safety Notices: 7 to 11 September 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 7 to 11 September 2020.
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Class 4 Medicines Defect Information: Zopiclone Tablets, Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan, EL (20)A/44
Ratiopharm UK Limited and Generics [UK] Limited t/a Mylan have confirmed that the Patient Information Leaflet (PIL) within all packs and the Summary of Product Characteristics (SmPC) for Ratiopharm is missing important …
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Field Safety Notices: 1 to 4 September 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 1 to 4 September 2020.
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Class 3 Medicines Recall: Accord Healthcare Limited, Amlodipine 10mg Tablets
Accord Healthcare Limited is recalling a specific batch of Amlodipine 10mg Tablets as a precautionary measure due to out of specification results obtained during stability testing.
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Class 4 FMD Medicines Information: WDA(H) 49276 Kingsley Specials Ltd, Multiple Products, (EL (20)A/42)
The MHRA is currently investigating an incident where several medicines appear to have left the legal supply chain and have then been re-introduced via Kingsley Specials Ltd WDA(H) 49276, who purchased from a company that do…
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Field Safety Notices: 24 - 28 August 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 24 August to 28 August 2020.
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Class 2 Medicines Recall: GL Pharma GmbH, Oxylan 40mg prolonged-release tablets, EL (20)A/41
GL Pharma is recalling a specific batch of Oxylan 40mg prolonged-release tablets due to out of specification results for dissolution during routine stability testing.
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Update: Wockhardt UK Ltd - Amoxicillin Sodium 1g, 250mg and 500mg Powder for Solution for Injection
Based on MHRA’s review of available data, the Commission on Human Medicines’ Paediatric Medicine Expert Advisory Group (PMEAG) has advised that Wockhardt UK’s Amoxicillin Sodium Powder for Solution for Injection can be used …
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Field Safety Notices: 17 - 21August 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 17 August to 21 August 2020.
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Class 2 Medicines Recall: Sanofi Fasturtec 7.5 mg, 1.5 mg/ml powder and solvent for concentrate for solution for infusion, EL (20)A/40
Sanofi is recalling batch number A9306 of the above product as a precautionary measure due to an out of specification result detected for Rasburicase enzyme activity according to a specific method and specifications for US m…
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Field Safety Notices: 10 - 14 August 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 10 August to 14 August 2020.
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Class 4 Medicines Defect Information: SmofKabiven extra Nitrogen Electrolyte Free, EL (20)A/39, PL 08828/0269
Fresenius Kabi Ltd & Calea UK Ltd has informed us of an error on the bag labels for SmofKabiven extra nitrogen electrolyte free, emulsion for infusion PL 08828/0269.
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Field Safety Notices - 31 July - 07 August 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 31 July to 07 August 2020.
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Class 2 Medicines Recall: Huddersfield Pharmacy Specials MS 19055, Phosphates Solution for Infusion 500ml, EL (20)A/38
Huddersfield Pharmacy Specials (HPS) is recalling the above batches of phosphates solution for infusion due to observation of precipitation in batch 500609X.
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Class 2 Medicines Recall: Pharmaram Ltd, Clexane 4,000 IU (40mg)/0.4ml Syringes, EL (20)A/37
Pharmaram Ltd has informed us that a specific batch of Clexane 4,000IU (40mg)/0.4ml syringes has an error on the labelling affixed to the plastic blister packaging encasing the syringe.
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Field Safety Notices - 27 July - 31 July 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 27 July to 31 July 2020
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Class 4 Medicines Defect Information: Crescent Pharma Ltd, SyreniRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system, EL (20)A/36
Crescent Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the below batches are missing important safety relevant text changes.
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Class 3 Medicines Recall: Accord-UK Ltd, Digoxin Tablets BP 250 micrograms, EL (20)A/35
Accord-UK Ltd has informed us of an issue related to decommissioning of a specific batch
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Class 2 Medicines Recall: Kyowa Kirin Limited, Abstral 200 microgram sublingual tablets, EL (20)A/34
Kyowa Kirin Limited is recalling a specific batch as a precautionary measure, due to the reports of double tablets in a single blister pocket.
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Field Safety Notices - 20 July - 24 July 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 20 July to 24 July 2020
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Class 3 Medicines Recall: Accord Healthcare Limited, Irinotecan Hydrochloride Concentrate for Solution for Infusion 20mg/ml (5ml vial), EL (20)A/33
Accord Healthcare Limited is recalling the above batch as a precautionary measure, due to the observation of precipitation in the solution in the same batch marketed in another country (Malta).
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Philips sterilizable defibrillator internal paddles (specific models) – may fail to deliver therapy if pre-use checks are not followed (MDA/2020/022)
Manufactured by Philips – defibrillator internal paddles may wear over time and might fail to deliver therapy, so it is important to do routine operational checks between each usage.
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Class 4 Medicines Defect Information: Pfizer Limited, Ecalta 100mg powder for concentrate for solution for infusion, EL (20)A/32
Pfizer Limited has informed us that the packs for the affected batches below have not been packaged with the current version of the Patient Information Leaflet (PIL) containing updated storage instructions of the infusion so…
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Field Safety Notices - 13 July to 17 July 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 13 July to 17 July 2020
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Class 4 Medicines Defect Information: Ennogen Pharma Limited, Trimogal 100mg and 200mg Tablets, EL (20)A/31
Ennogen Pharma Limited has informed us that the Patient Information Leaflets (PILs) within the packs for the affected batches below contain an error in Section 3 (How To Take Trimogal Tablets) with regard to the dosage instr…
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Masks: type IIR (originally distributed by Cardinal Health) – destroy all lots
Foam strip on the mask can flake and enter the wearer’s airway or mouth; ties and/or stitching may detach from the mask.
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Class 4 Medicines Defect Information: Aspar Pharmaceuticals Limited, Ibuprofen 200mg and 400mg tablets packaged in various liveries, EL (20)A/30
Aspar Pharmaceuticals Limited has informed us that the Patient Information Leaflets (PILs) within the ibuprofen packs below are missing some information identified from post-marketing experience that should be documented in …
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Class 2 Medicines Recall: Ferring Pharmaceuticals Limited, desmopressin nasal spray (all strengths), PL 03194/0024, PL 03194/0090, PL 03194/0056, EL (20)A/29
Ferring Pharmaceuticals Limited is recalling all unexpired stock of the products below from pharmacies and wholesalers as a precautionary measure due to a lower volume of solution being observed in the bottles, and out of sp…
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Class 2 Medicines Recall: Nitrofurantoin 50 mg Tablets, PL 08553/0087, EL (20)A/28
Dr Reddy’s Laboratories (UK) Limited is recalling all unexpired stock of a specific batch of Nitrofurantoin 50mg Tablets from pharmacies and wholesalers as a precautionary measure due to out of specification results for diss…
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Field Safety Notices - 06 July to 10 July 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 06 July to 10 July 2020
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Spinal fixation system – risk of implant failure prior to completion of bone healing (MDA/2020/020)
Manufactured by Synthes GmbH – cracking of the USS II Polyaxial 3D Head rings may result in loosening of the fixation system prior to completion of bone healing.
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Field Safety Notices - 29 June to 03 July 2020
Summary list of field safety notices (FSNs) from medical device manufacturers from 29 June to 03 July 2020
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Abbott Trifecta / Trifecta GT bioprosthetic aortic heart valves: cases of structural valve deterioration (SVD) (MDA/2020/019)
Manufactured by Abbott – cases of valvular insufficiency and early revision.
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Class 2 Medicines Recall: Mepacrine Hydrochloride 100 mg Tablets (Batch 85641), EL (20)A/27
BCM Specials Limited is recalling a specific batch of Mepacrine Hydroxychloride 100 mg tablets due to a number of foreign body particulates found in the containers of the API used to make it.
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Class 4 Medicines Defect Information: Depo-Provera 150mg/ml Injection (1ml Vial) EL (20)A/26
Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder) has informed us of a typographical error in active ingredient stated on the label on the vial.