Drug product
Testosterone 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
D-1746-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 240 pellets
- Official record key
drug-enforcement:D-1746-2015
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; 12102014@3, 6/8/2015; 12042014@62, 6/2/2015; 01192015@15, 7/18/2015; 01062015@12, 7/5/2015; 02202015@23, 8/19/2015; 02242015@35, 8/23/2015; 03032015@17, 8/30/2015; 03252015@9, 9/21/2015; 04292015@19, 10/26/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility