Industry News
The latest medical device regulatory news, clinical trials, and market insights
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…
FDA Introduces Daily Updates on Adverse Event Reporting for Drug Safety Insights
The U.S. Food and Drug Administration (FDA) has announced a major step forward in public health transparency by initiating daily…
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…
FDA Demands Safer Nicotine Pouch Packaging Amid Rising Cases of Child Exposure
The U.S. Food and Drug Administration (FDA) has issued a strong appeal to nicotine pouch manufacturers, urging them to adopt…
Urgent Notification: Superseded Patient Information in Erythromycin Stearate BP 250mg Tablet Batch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…
FDA Introduces Groundbreaking Guidance to Streamline Rare Disease Drug Development
The U.S. Food and Drug Administration (FDA) has launched the Rare Disease Evidence Principles (RDEP) initiative, promising faster and more…
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…
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…
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…
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…
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)…
FDA Urges Retailers to Cease Illegal Vape Sales in New Compliance Initiative
Marty Makary, M.D., M.P.H., Commissioner of the U.S. Food and Drug Administration (FDA), has announced a pivotal step in addressing…