Drug product
Morphine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
D-1585-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 429 ml total volume
- Official record key
drug-enforcement:D-1585-2015
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@1, 5/26/2015; 03062015@38, 6/4/2015; 03162015@77, 6/14/2015; 03242015@44, 6/22/2015; 03242015@51, 6/22/2015; 04072015@58, 7/6/2015; 04132015@6, 6/12/2015; 04142015@60, 6/13/2015; 04222015@12, 6/21/2015; 05122015@16, 7/11/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility