Product: Tri-Mix ST4 (3 mg/1.5 mg/300 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
Reason for recall: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated: 20150602
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated