Patient Safety Alert: Missing Safety Details in Chemidex Pharma’s Topical Steroid PILs
On October 2, 2025, Chemidex Pharma Ltd notified the Medicines and Healthcare products Regulatory Agency (MHRA) about incomplete safety information…
Regulatory Affairs
Global updates on medical device regulation and quality.
441 articles
441 articles in Regulatory Affairs
Europe
Europe
Urgent Recall Alert: BD ChloraPrep Clear 1mL Applicators Risk Contamination
Becton Dickinson UK Ltd has issued an urgent recall for specific units of BD ChloraPrep Clear 1mL Applicators, citing a…
Europe
Recent Updates on Field Safety Notices: Key Alerts from 12 to 16 May 2025
Between 12 and 16 May 2025, several medical device field safety notices were issued, highlighting critical adjustments and updates necessary…
Europe
Precautionary Recall Alert: Mercaptopurine 50mg Tablets from Aspen Pharma Due to Microbial Contamination
Aspen Pharma Trading Limited has initiated a recall of a specific batch of Mercaptopurine 50mg tablets distributed under brand name(s).…
Europe
Philips Respironics BiPAP A-Series Ventilators Alarm Failure: Therapy Disruption Risks Highlighted in Recent Safety Notice
Philips Respironics has issued a Field Safety Notice (FSN) concerning its BiPAP A-Series ventilators. This advisory highlights a malfunction in…
Europe
Zentiva Alert: MHRA Notified of Medicine Batch Consistency Concerns
On October 2, 2025, Zentiva Pharma UK Limited informed the Medicines and Healthcare products Regulatory Agency (MHRA) about a quality…
Europe
Critical Updates: Field Safety Notices Issued from 26 to 30 May 2025
Several new Field Safety Notices (FSNs) were issued between 26 and 30 May 2025, providing vital updates for healthcare professionals…
Europe
Urgent Recall of Paracetamol 500mg Tablets Due to Contamination Risk: Critical Information for Healthcare Stakeholders
Chelonia Healthcare Limited is issuing an urgent recall of specific batches of Paracetamol 500mg tablets due to potential contamination. This…
Europe
Temporary Approval Granted for Imjudo Infusion Solution in German Packaging
Swissmedic has announced a temporary market authorization for Imjudo, a concentrate used in the preparation of an infusion solution. This…
Europe
Essential Field Safety Notices: Key Updates from 2–6 June 2025
In early June 2025, a series of Field Safety Notices were issued highlighting updates and recalls for medical devices across…
Europe
Spotlight on Post-Market Surveillance: Insights from the 23rd IMDRF Session Joint Workshop
Meta description: A new white paper highlights essential observations from the 23rd IMDRF Session Joint Workshop on enhancing post-market activities…
Europe
Critical Update: Incorrect Dose Instruction on Dulcolax 5mg Tablets Outer Carton
On October 2, 2025, Opella Healthcare UK LTD issued an urgent notification regarding a packaging error for the outer carton…
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