Drug product
Testosterone 87.5 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
D-1751-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 265 pellets
- Official record key
drug-enforcement:D-1751-2015
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@60, 8/29/2015; 12042014@65, 6/2/2015; 12182014@39, 6/16/2015; 01152015@37, 7/14/2015; 01052015@1, 7/4/2015; 02052015@50, 8/4/2015; 02132015@14, 8/12/2015; 03162015@14, 9/12/2015; 03252015@14, 9/21/2015; 04222015@44, 10/19/2015, 05042015@28, 10/31/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility