Drug product
S-TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE; Rx Only, a) 10ml b) 13ml glass vials. Red Mountain Compounding Rx.
D-0288-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4x 10ml and 13 ml glass vials
- Official record key
drug-enforcement:D-0288-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: a) S05212019DH@13, Exp 8/21/19; S06302019DH@07, Exp 9/30/19; S07252019DH@10, Exp 10/25/19; b) S05092019DH@05, Exp 8/9/19;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility