Drug product
S-DEXTROSE 50% MDV SOLN, 50 ML glass vial, RX Only, Red Mountain Compounding RX
D-0212-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5x50 ml glass vial
- Official record key
drug-enforcement:D-0212-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S06092019DH@09, Exp 9/9/19; S06252019DT@11, 9/25/19; S07092019DT@07, Exp 10/9/19; S07092019DT@13, Exp 10/9/19;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility