Drug product
S-MIC 25/50/50 B12A 5MG/ML MDV SOLN; Rx Only, 30ml Glass vial, Red Mountain Compounding Rx.
D-0276-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7x30 ml glass vials
- Official record key
drug-enforcement:D-0276-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S03302019DT@02, Exp 09/30/2019, S05062019DH@12, Exp 11/06/2019, S06162019DH@13, Exp 12/16/2019, S07132019DT@05, Exp 01/13/2020,
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility