Drug product
MIC+Methylcobalamin 4000 mcg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
D-1577-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1076 ml total
- Official record key
drug-enforcement:D-1577-2015
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; 03172015@50, 6/15/2015; 04142015@11, 7/13/2015; 03232015@32, 6/21/2015; 03232015@37, 6/21/2015; 03302015@53, 6/28/2015; 04142015@10, 7/13/2015; 04302015@47, 7/29/2015; 04292015@84, 7/28/2015; 05042015@55, 8/2/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility