Drug product
S-MIC 25/50/50MG/ML MDV SOLN, 30ml glass vial, Rx Only, Red Mountain Compounding RX.
D-0241-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24x30 ml vials
- Official record key
drug-enforcement:D-0241-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S02142019DH@01, Exp 8/14/19; S03112019DT@04, Exp 09/11/2019, S03192019DT@04, Exp 9/19/19; S04162019DT@15, Exp 10/16/19; S07172019DT@10, Exp 1/17/20; S07232019DH@04, Exp 1/23/20;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility