Drug product
Testosterone 75 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
D-1655-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 192 pellets
- Official record key
drug-enforcement:D-1655-2015
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; 05072015@42, 11/3/2015; 12292014@9, 6/27/2015; 12032014@12, 6/1/2015; 12042014@73, 6/2/2015; 02272015@63, 8/26/2015; 05042015@44, 10/31/2015; 03302015@9, 9/26/2015; 04092015@46, 10/6/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility