REGULATORY INTELLIGENCE·Warning Letter
Astellas Pharma US Initiates Class I Recall for PROGRAF (Tacrolimus) Capsules Over Empty Capsule Defect
Astellas Pharma US, Inc. has initiated a Class I recall for PROGRAF (tacrolimus) capsules due to bottles potentially containing empty capsules. This critical defect poses significant patient safety risks for transplant recipients, necessitating immediate action from procurement and regulatory teams. The nationwide distribution of this essential immunosuppressant highlights supply chain vulnerabilities and demands a swift, comprehensive response from Astellas.
90-Day Activity