Drug product
Testosterone 200 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
D-1745-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 510 pellets
- Official record key
drug-enforcement:D-1745-2015
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; 12122014@8, 6/10/2015; 12042014@47, 6/2/2015; 01122015@54, 7/11/2015; 04142015@82, 10/11/2015; 01072015@32, 7/6/2015; 01192015@17, 7/18/2015; 02042015@43, 8/3/2015; 02232015@35, 8/22/2015; 02272015@30, 8/26/2015; 02272015@19, 8/26/2015; 03162015@55, 9/12/2015; 03192015@23, 9/15/2015; 03192015@33, 9/15/2015; 04012015@55, 9/28/2015; 04072015@42, 10/4/2015, 04072015@6, 10/4/2015; 04102015@46, 10/7/2015; 04162015@56, 10/13/2015; 04282015@7, 10/25/2015, 04272015@59, 10/24/2015; 04302015@59, 10/27/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility