Drug product
Testosterone 60 mg Anastrazole 4 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
D-1657-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 85 pellets
- Official record key
drug-enforcement:D-1657-2015
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; 12032014@36, 6/1/2015; 12082014@22, 6/6/2015; 01202015@19, 7/19/2015; 05042015@81, 10/31/2015; 05112015@19, 11/7/2015; 04282015@44, 10/25/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility