Regulatory Alert: Recall of Kimmtrak 200 micrograms/mL Due to Potency Issues
Immunocore Limited is urgently recalling specific batches of its Kimmtrak 200 micrograms/mL concentrate for solution for infusion after stability testing…
UK
uk updates on medical device regulation and quality.
84 articles
84 articles in UK
Europe
Europe
Urgent Recall: Depo-Medrone Labeling Error Poses Dosage Risk
A recall has been issued for a batch of Depo-Medrone 80 mg in 2 mL vials due to a critical…
Europe
Urgent Recall of Batch-Specific Omeprazole Oral Solution Due to Quality Concerns
On October 2, 2025, Glenmark Pharmaceuticals Europe Ltd announced a precautionary recall of a specific batch of its Omeprazole 20…
Europe
Tamoxifen 20mg Tablets Recall: Stability Testing Uncovers Dissolution Issue
Wockhardt UK Limited issued a precautionary recall of a batch of Tamoxifen 20mg film-coated tablets after stability testing revealed a…
Europe
Urgent Notification: Superseded Patient Information in Erythromycin Stearate BP 250mg Tablet Batch
Amdipharm UK Ltd has reported a critical issue regarding a batch of Erythromycin Stearate BP 250mg tablets. The Patient Information…
Europe
Critical Advisory: New Aurum 10ml CONNECT Syringe Barrel Requires Compatible Needle-Free Connectors to Prevent Blockages
Healthcare professionals are urged to adopt compatible needle-free connectors (NFCs) with the newly phased-in Aurum 10ml CONNECT syringe barrels. This…
Europe
Critical Update: Barcode Error Identified in Simvastatin 10mg From Crescent Pharma
Crescent Pharma Limited has reported a significant issue related to one of its distributed products, Simvastatin 10mg Tablets, in the…
Europe
Zaditen Eye Drops Recall Announced Over Microbial Contamination Risks
In a recent update concerning pharmaceutical safety, Thea Pharmaceuticals Limited (trading as Laboratoires Théa) initiated a Class 2 Medicines Recall…
Europe
Critical Updates: Field Safety Notices Released for 30 June to 4 July 2025
Healthcare professionals specializing in clinical, quality, and regulatory affairs should note the latest developments regarding medical device safety. A comprehensive…
Europe
Critical Updates: Field Safety Notices Published for Medical Devices (7–11 July 2025)
Healthcare professionals and teams responsible for compliance and patient safety should take note of the latest Field Safety Notices (FSNs)…
Europe
Latest Field Safety Notices Highlight Critical Updates for Medical Devices: 14–18 July 2025
Medical device professionals should be aware of the latest Field Safety Notices (FSNs) published between 14 July and 18 July…
Europe
Critical Update: Positive Bias Detected in Trinity Biotech Premier Hb9210™ HbA1c Analyser Results
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert regarding the Trinity Biotech Premier Hb9210™ HbA1c…
Loading more articles…