REGULATORY INTELLIGENCE·Recall
AnazaoHealth Corporation Initiates Nationwide Class II Recall of Thiamine HCl/Pyridoxine HCl Injection Due to Particulate Matter
AnazaoHealth Corporation initiated a nationwide Class II recall (D-0204-2024) for 3,363 vials of Thiamine HCl/Pyridoxine HCl Injection Solution due to particulate matter. This event, terminated by the FDA, underscores critical quality control failures in sterile compounding. Procurement and regulatory teams must scrutinize injectable suppliers, reinforcing robust qualification processes to mitigate patient safety risks and supply chain disruptions from similar quality lapses.
90-Day Activity
AnazaoHealth Corporation
CMCatherine Morrow· Senior Regulatory Intelligence Analyst2024-01-03