Drug product
S-E2/TEST CYP 0.4MG/1MG/MLMDV IN OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx.
D-0215-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1x10 glass vials
- Official record key
drug-enforcement:D-0215-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S06262019DT@08, Exp 9/26/19;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility