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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鈥�
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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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Based on MHRA鈥檚 review of available data, the Commission on Human Medicines鈥� Paediatric Medicine Expert Advisory Group (PMEAG) has advised that Wockhardt UK鈥檚 Amoxicillin Sodium Powder for Solution for Injection can be used 鈥�
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Summary list of field safety notices (FSNs) from medical device manufacturers from 17 August to 21 August 2020.
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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鈥�
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Summary list of field safety notices (FSNs) from medical device manufacturers from 10 August to 14 August 2020.
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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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Summary list of field safety notices (FSNs) from medical device manufacturers from 31 July to 07 August 2020.
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Huddersfield Pharmacy Specials (HPS) is recalling the above batches of phosphates solution for infusion due to observation of precipitation in batch 500609X. The decision to recall all other batches has been made as a precau鈥�
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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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Summary list of field safety notices (FSNs) from medical device manufacturers from 27 July to 31 July 2020
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Accord-UK Ltd has informed us of an issue related to decommissioning of a specific batch
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Kyowa Kirin Limited is recalling a specific batch as a precautionary measure, due to the reports of double tablets in a single blister pocket. This was identified during reference sample inspection and there is a potential l鈥�
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Summary list of field safety notices (FSNs) from medical device manufacturers from 20 July to 24 July 2020
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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). No complaints or adverse react鈥�
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Manufactured by Philips 鈥� 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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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鈥�
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Summary list of field safety notices (FSNs) from medical device manufacturers from 13 July to 17 July 2020
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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鈥�
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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 鈥�
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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鈥�
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Dr Reddy鈥檚 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鈥�
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Summary list of field safety notices (FSNs) from medical device manufacturers from 06 July to 10 July 2020
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Manufactured by Synthes GmbH 鈥� 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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Summary list of field safety notices (FSNs) from medical device manufacturers from 29 June to 03 July 2020
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Manufactured by Abbott 鈥� cases of valvular insufficiency and early revision.
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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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Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder) has informed us of a typographical error in active ingredient stated on the label on the vial.
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Manufactured by Philips 鈥� the rotary therapy selector switch may fail resulting in unexpected device behaviours which could lead to a delay or failure in delivering therapy.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 22 June to 26 June 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 15 to 19 June 2020
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The Philips HeartStart MRx Monitor/Defibrillator MRx may fail to identify a fault and alert the user in the event of internal damage suffered during a drop or due to severe mechanical shock.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 08 to 12 June 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 01 to 05 May 2020
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Torbay Pharmaceuticals is recalling specific batches of Epistatus (Midazolam) 10mg/mL Oromucosal Solution (Multi Dose Bottles) due to a potentially faulty and incorrectly engaged child-resistant container closure.
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This covers issues with both laboratory based tests for COVID-19 antibodies (unvalidated sample type) and capillary blood sample collection kits (unvalidated for home use)
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Summary list of field safety notices (FSNs) from medical device manufacturers from 27 to 29 May 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 18 to 22 May 2020
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Torbay Pharmaceuticals has informed us that the carton label on Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection incorrectly states the concentration of disodium edetate (excipient) as 0.1% w/v (10mg in 1鈥�
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As a precautionary measure, Pfizer Limited is recalling the above batches from wholesalers due to out of specification results from the ongoing stability studies. An evaluation of the foil laminate pouch identified oxygen le鈥�
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Summary list of field safety notices (FSNs) from medical device manufacturers from 11 to 15 May 2020
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Pharmaswiss 膶eska republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 500 microgram auto-injectors (also referred to as pens) from patients due to an error in one com鈥�
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Summary list of field safety notices (FSNs) from medical device manufacturers from 4 to 8 May 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 27 April to 1 May 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 20 to 24 April 2020
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Summary list of field safety notices (FSNs) from medical device manufacturers from 13 to 17 April 2020
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GSK has informed us that due to a machinery defect with the printing line, a small number of packs may not have the batch number and expiry date printed on the outer cartons. The correct information is printed on the blister鈥�
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TEVA UK Limited has informed us that the Product Code/GTIN (PC) number found on the below batches is incorrect.
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Summary list of field safety notices (FSNs) from medical device manufacturers from 6 to 9 April 2020
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All manufacturers 鈥� there have been reports of off-label modifications to haemofiltration systems when treating Covid-19 patients leading to serious injury and death.