Drug product
Estradiol 15 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
D-1467-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 pellets
- Official record key
drug-enforcement:D-1467-2015
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; 11262014@20, 5/25/2015; 01152015@27, 7/14/2015; 02232015@21, 8/22/2015; 02242015@23, 8/23/2015; 05052015@68, 11/1/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility