Drug product
S-SOD CITRATE 4% INJ SOLN MDV, 10 ML glass vial, Red Mountain Compounding Rx
D-0249-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3x10 ml glass vials
- Official record key
drug-enforcement:D-0249-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S07102019DT@12, Exp 8/10/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility