Drug product
Morphine 25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
D-1592-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 458 ml total volume
- Official record key
drug-enforcement:D-1592-2015
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; 02252015@2, 5/26/2015; 03022015@14, 5/31/2015; 03242015@63, 6/22/2015; 04072015@62, 7/6/2015; 04222015@15, 7/21/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility