Drug product
Testosterone 200 mg Anastrazole 9 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
D-1659-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 94 pellets
- Official record key
drug-enforcement:D-1659-2015
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; 01292015@32, 7/28/2015; 02232015@18, 5/20/2015; 02272015@31, 8/26/2015; 03092015@23, 9/5/2015; 03272015@32, 9/23/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility