Drug product
S-PROGESTERONE/TESTOSTERONE 0.05%/0.03% OIL OPTH, Rx Only 10ml dropper bottle, Red Mountain Compounding Rx.
D-0246-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1x10ml droptainer
- Official record key
drug-enforcement:D-0246-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S05232019DT@13, Exp 8/23/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility