Drug product
Morphine 50 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
D-1607-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 944 ml total volume
- Official record key
drug-enforcement:D-1607-2015
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; 04142015@54, 6/13/2015; 04092015@68, 6/8/2015; 02252015@6, 5/26/2015; 05042015@68, 7/3/2015; 03022015@20, 05/31/2015; 031192015@5, 6/9/2015; 03092015@22, 6/7/2015; 03122015@3, 6/10/2015; 03162015@81, 6/14/2015; 03242015@74, 6/22/2015, 03302015@64, 6/28/2015; 04062015@46, 7/5/2015; 04212015@25, 6/20/2015; 04222015@18, 6/21/2015, 04242015@56, 6/23/2015; 04272015@29, 6/26/2015; 05012015@18, 6/30/2015; 05082015@32, 7/7/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility