Drug product
S-E2/TEST CYP 1MG/4MG SESAME OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx.
D-0216-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2x10 ml glass vials
- Official record key
drug-enforcement:D-0216-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S05212019DT@06 Exp, 5/21/19; S06262019DT@08, Exp 6/26/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility