Drug product
Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN
D-1453-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 260 mL total volume
- Official record key
drug-enforcement:D-1453-2015
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; 03102015@17, 6/8/2015; 03032015@14, 6/1/2015; 03272015@1, 6/25/2015; 04292015@79, 7/28/2015, 04282015@51, 7/27/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility