Drug product
Alprostadil 10 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
D-1436-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 130 mL total
- Official record key
drug-enforcement:D-1436-2015
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; 12052014@40, 6/3/2015; 12182014@71, 6/16/2015; 01022015@12, 7/1/2015; 02112015@56, 8/10/2015; 02132015@47, 8/12/2015; 03062015@26, 9/2/2015; 03312015@23, 9/27/2015; 04162015@2, 10/13/2015; 05012015@26, 10/28/2015; 05072015@15, 11/3/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility