Drug product
Ascorbic Acid 500 mg/ml Injectable Vial, Sterile Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
D-1442-2015
Product summary
- Event
- Event 71371
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2923 mL total volume
- Official record key
drug-enforcement:D-1442-2015
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; 05052015@1, 8/3/2015; 03112015@4, 6/9/2015; 03122015@32, 6/10/2015; 03122015@90, 6/10/2015; 03232015@6, 6/21/2015; 03272015@38, 6/25/2015; 04072015@21, 7/6/2015; 05112015@75, 8/9/2015; 04222015@9, 7/21/2015
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
GMP violations
-
Sterility assurance
Lack of Assurance of Sterility