Drug product
Tri-Mix ST9E (60 mg/4 mg/150 mcg) Injectable, Sterile Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
D-1801-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 79 ml
- Official record key
drug-enforcement:D-1801-2015
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@24, 8/10/2015; 02032015@101, 8/2/2015, 04012015@21, 9/28/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility