Drug product
Vitatrim Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
D-1723-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3215 ml
- Official record key
drug-enforcement:D-1723-2015
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; 04102015@70, 7/9/2015; 04212015@9, 7/20/2015; 04092015@75, 7/8/2015; 03022015@1, 5/31/2015; 04202015@12, 7/19/2015; 03112015@19, 6/9/2015; 03032015@36, 6/1/2015; 03032015@40, 6/1/2015; 03062015@28, 6/4/2015; 03192015@5, 6/17/2015; 03202015@15, 6/18/2015; 03172015@18, 6/15/2015; 03172015@27, 7/13/2015; 03202015@87, 6/18/2015; 03242015@35, 6/22/2015; 05042015@76, 8/2/2015; 03272015@9, 6/25/2015; 03312015@14, 6/29/2015; 03272015@33, 6/25/2015; 03272015@43, 6/25/2015; 04012015@37, 6/30/2015; 04022015@32, 7/1/2015; 04162015@39, 7/15/2015; 04232015@5, 7/22/2015; 04212015@65, 7/20/2015; 04222015@48, 7/21/2015; 04272015@65, 7/26/2015; 05052015@96, 8/3/2015; 05012015@34, 7/30/2015; 05052015@87, 8/3/2015; 05072015@53, 8/5/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility