Drug product
Estradiol 6 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
D-1475-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 144 pellets
- Official record key
drug-enforcement:D-1475-2015
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; 11212014@13, 5/20/2015; 12182014@35, 6/16/2015; 02202015@1, 8/19/2015; 03022015@48, 8/29/2015; 03172015@33, 9/13/2015; 04232015@24, 10/20/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility