Drug product
S-TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10ml glass vials, Red Mountain Compounding Rx
D-0252-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13x5 and 10 ml glass vials
- Official record key
drug-enforcement:D-0252-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #:a) S02132019DT@02, Exp 8/13/19; b) S04092019DT@05, Exp 10/9/19; S06122019DH@35, Exp 12/12/19; S06172019DH@04, Exp 12/17/19;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility