Drug product
Estradiol 10 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
D-1464-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 212 pellets
- Official record key
drug-enforcement:D-1464-2015
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; 12082014@56, 6/6/2015; 01222015@28, 7/21/2015; 01062015@73, 7/5/2015; 03022015@55, 8/29/2015; 03242015@94, 9/20/2015; 04222015@32, 10/19/2015; 04222015@47, 10/19/2015; 04222015@49, 10/19/2015; 04302015@54, 10/27/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility