Drug product
Testosterone Cypionate 220 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
D-1756-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 138 ml
- Official record key
drug-enforcement:D-1756-2015
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; 11242014@36, 5/23/2015; 12042014@53, 6/2/2015; 12222014@67, 6/20/2015; 02192015@5, 8/18/2015, 05042015@77, 10/31/2015; 05052015@54, 11/1/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility