Drug product
Tri-Mix (17.7/0.59/6) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
D-1766-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 62 ml
- Official record key
drug-enforcement:D-1766-2015
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; 01082015@10, 7/7/2015; 12192014@10, 6/17/2015; 12022014@4, 5/31/2015; 12302014@56, 6/28/2015; 01262015@84, 7/25/2015, 03302015@51, 9/26/2015; 05052015@83, 11/1/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility