Drug product
B-Complex Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
D-1444-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1397 mL total volume
- Official record key
drug-enforcement:D-1444-2015
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; 02192015@21, 5/20/2015; 03032015@3, 6/1/2015; 02242015@37, 5/25/2015; 03122015@27, 6/10/2015; 03182015@48, 6/16/2015; 03272015@14, 6/25/2015; 04072015@16, 7/6/2015, 04072015@18, 7/6/2015, 04202015@80, 7/19/2015, 04222015@85, 7/21/2015; 05072015@25, 8/5/2015; 04272015@74, 7/26/2015; 04272015@81, 7/26/2015; 04292015@98, 7/28/2015; 05012015@17, 7/30/2015; 05042015@45, 8/2/2015; 02202015@47, 5/21/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility