Immunocore Limited is urgently recalling specific batches of its Kimmtrak 200 micrograms/mL concentrate for solution for…
Category: Europe
europe updates on medical device regulation and quality.
IMDRF Launches Online Membership Forms: A Streamlined Submission Process
From May 2025, regulatory professionals and other stakeholders involved with medical device oversight will benefit from…
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…
Breaking News: GHWP Withdraws Membership from IMDRF
On June 24, 2025, the Global Harmonization Working Party (GHWP) officially withdrew from the International Medical…
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…
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…
Urgent Notification: Superseded Patient Information in Erythromycin Stearate BP 250mg Tablet Batch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…
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…
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…
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…