Drug product

Tri-Mix ST1 (30 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN

D-1792-2015

June 02, 2015

Class II

Product summary

Firm: The Compounding Pharmacy of America
Event: Event 71371
Status: Terminated
Classification: Class II
Quantity: 145 ml
Official record key: drug-enforcement:D-1792-2015

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@15, 8/10/2015 04012015@18 9/28/2015 04272015@52 10/24/2015 05052015@14 11/1/2015

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