Drug product
Tri-Mix Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
D-1720-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-1720-2015
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; 01202015@30, 7/19/2015; 01262015@22, 7/25/2015; 02092015@14, 7/1/2015; 02192015@12, 8/18/2015; 03202015@86, 9/16/2015; 03232015@25, 9/19/2015; 04282015@14, 10/25/2015; 04282015@18, 10/25/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility