Drug product
Testosterone 50 mg Pellet, Sterile, The Compounding Pharmacy of America, Inc., Knoxville, TN
D-1651-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 216 pellets
- Official record key
drug-enforcement:D-1651-2015
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; 12032014@47, 6/1/2015; 12052014@36, 6/3/2015; 12192014@33, 6/17/2015; 01202015@53, 7/19/2015; 01062015@58, 7/5/2015; 02122015@40, 8/11/2015; 03022015@15, 8/29/2015; 03252015@22, 9/21/2015; 05082015@6, 11/4/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility