Drug product
Testosterone 37.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
D-1748-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 144 pellets
- Official record key
drug-enforcement:D-1748-2015
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; 03022015@79, 8/29/2015; 12092014@5, 6/7/2015; 12042014@28, 6/2/2015; 01152015@30, 7/14/2015; 04152015@24, 10/12/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility