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List of Field Safety Notices (FSNs) from 13 to 17 March 2023
Specific batches of products supplied by Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity.
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 due to risks of reduced product quality.
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 market, at 12 months stability...
Specific batches of products supplied by the Marketing Authorisation Holders and parallel distributor companies are being recalled due to presence of a mutagenic impurity.
Novartis Pharmaceuticals has informed the MHRA that the solvent (water for injections in ampoules) co-packed with the impacted batches of Simulect powder for injection, may contain glass fragments approximately 20 – 800 µm in size.
Recent MHRA National Patient Safety Alerts to remove from service Philips Health Systems V60 and V60 Plus ventilators and to recall Emerade adrenaline auto-injectors from patients, pharmacies and wholesalers. We also provide a summary of recent letters and notifications sent...
Summary list of field safety notices (FSNs) from medical device manufacturers from 19 April to 23 April 2021
Upper Tribunal Tax and Chancery decision of Mr Justice Miles and Judge Rupert Jones on 05 July 2022
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