Drug product

Tri-Mix ST9A (30 mg/2 mg/80 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1799-2015

June 02, 2015

Class II

Product summary

Firm: The Compounding Pharmacy of America
Event: Event 71371
Status: Terminated
Classification: Class II
Quantity: 112 ml
Official record key: drug-enforcement:D-1799-2015

Official wording

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

Code information: All lots distributed between November 2014 and May 2015; 02112015@19, 8/10/2015; 02032015@77, 8/2/2015; 04012015@19, 9/28/2015; 04272015@54, 10/24/2015

Distribution pattern: Nationwide

Derived failure modes

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

GMP violations
Sterility assurance
reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility