Drug product
S-DEXTROSE/GLYCERIN/PHENOL 25/25/2.5% INJ SOLN, 30 ml glass vial, Rx Only, Red Mountain Compounding Rx
D-0210-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8x30 ml glass vial
- Official record key
drug-enforcement:D-0210-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S07292019DH@13, Exp 8/29/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility