Tri-Mix ST9E (60 mg/4 mg/150 mcg) Injectable, Sterile Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Recall Number: D-1801-2015

Firm: The Compounding Pharmacy of America

Classification: Class II

Status: Terminated

Report Date: 20150923

Initiation Date: 20150602

Termination Date: 20160210

Reason for Recall

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Product Description

Tri-Mix ST9E (60 mg/4 mg/150 mcg) Injectable, Sterile Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN