Drug product
S-TESTOSTERONE CYP 100MG/ML in SESAME OIL, 5ml Rx only, Red Mountain Compounding Rx.
D-0280-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1x5ml glass vial
- Official record key
drug-enforcement:D-0280-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S05292019dt@01, Exp 8/29/19;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility