Drug product
Estradiol 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
D-1466-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 144 pellets
- Official record key
drug-enforcement:D-1466-2015
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; 01082015@8, 7/7/2015; 12052014@62, 6/3/2015; 02242015@10, 8/23/2015; 02122015@29, 7/1/2015; 03032015@19, 8/30/2015; 04232015@13, 10/20/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility