Drug product
Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
D-563-2013
Product summary
- Event
- Event 65125
- Status
- Terminated
- Classification
- Class II
- Quantity
- 78 vials of 500ml and 92 vials of 100mL
- Official record key
drug-enforcement:D-563-2013
Official wording
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Code information: All Lots
Distribution pattern: Florida, California, Minnesota, and Maine
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility