Drug product
S-GLYCERIN 72% INJECTION SOLN, 30ML glass vial, Red Mountain Compounding RX
D-0225-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5x30 ML vials
- Official record key
drug-enforcement:D-0225-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S05142019DT@09, Exp 8/14/19; S07162019DT@14, Exp 10/16/19; S07232019DH@06, Exp 10/23/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility