Drug product
Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
D-1568-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 63 ml total
- Official record key
drug-enforcement:D-1568-2015
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; 04212015@8, 7/20/2015; 03032015@11, 6/1/2015; 03102015@49, 6/8/2015; 03192015@9, 6/17/2015; 05042015@14, 8/2/2015; 04072015@20, 7/6/2015; 05042015@51, 8/2/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility