Drug product
Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
D-1637-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 159 ml
- Official record key
drug-enforcement:D-1637-2015
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; 03112015@2, 6/9/2015; 03162015@6/14/2015; 03242015@2, 6/22/2015, 03302015@62, 6/28/2015, 0406201@43, 7/5/2015; 04142015@62, 7/13/2015, 04122015@6/20/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility