Drug product
S-TEST CYP/PROP 160/40MG/ML MDV IN SESAME OIL; Rx Only, a) 10ml b) 13 ml glass vials, Red Mountain Compounding Rx.
D-0290-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3x 10ml and 13 ml glass vials
- Official record key
drug-enforcement:D-0290-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #:a) S06182019DH@03, Exp 9/18/19; S07292019DH@04, Exp 10/29/19; b) S07092019DT@12, Exp 10/9/19;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility