Regulatory Affairs

Fucidin 250 mg Tablets Recall Announced Due to Impurity Concerns

On September 30, 2025, LEO Pharma issued a recall notice for one batch of Fucidin 250 mg Tablets following routine…

FDA Issues Advisory: Medline Kits Potentially Contain Defective Medtronic Heart Ventilation Cannulas

The U.S. Food and Drug Administration (FDA) has released a critical early alert regarding certain Medline Convenience Kits, which may…

Critical Updates: Field Safety Notices for Medical Devices (28 July – 1 August 2025)

Between 28 July and 1 August 2025, healthcare teams were informed of updates to multiple Field Safety Notices (FSNs) related…

FDA Alert: mo-Vis BVBA Issues Firmware Update Recall for R-net Wheelchair Joysticks

Mo-Vis BVBA has announced an urgent firmware correction for their R-net joystick devices used in powered wheelchairs. This update responds…

Medical Alert: Label and Packaging Error Identified for Topiramate Zydus 20mg/ml Oral Solution

Zydus Pharmaceuticals UK Ltd has released a critical notification regarding an error on the packaging and patient information leaflet (PIL)…

FDA Warns Against Using Unauthorized Infant Vital Sign Monitors

The FDA issued a critical safety communication on September 16, 2025, advising against the use of unauthorized infant devices designed…

Critical Updates: Field Safety Notices Issued From 4 to 8 August 2025

Clinical, quality, and regulatory teams should note the latest field safety notices issued between 4 and 8 August 2025. These…

FDA Warns Against Unauthorized Blood Pressure Devices: What You Need to Know

The U.S. Food and Drug Administration (FDA) has issued an important safety communication regarding blood pressure measurement devices. This announcement,…

FDA to Publish Complete Response Letters in Real-Time: New Policy Transforming Regulatory Transparency

The U.S. Food and Drug Administration (FDA) has announced a significant shift in its regulatory communication practices. Starting immediately, the…

Urgent Update: Safety Information Missing in Levetiracetam Accord Oral Solution Documents

Accord Healthcare Limited, UK has formally notified the Medicines and Healthcare products Regulatory Agency (MHRA) of a critical defect related…

FDA Warns Against Imported Cookware Linked to Dangerous Lead Contamination

The U.S. Food and Drug Administration (FDA) has issued a critical update urging both retailers and consumers to stop selling…

FDA Introduces Green List to Prevent Unsafe GLP-1 Drug Imports

The U.S. Food and Drug Administration (FDA) has launched a significant regulatory measure aimed at curbing the entry of illegal…