Drug product
S-MICB12C/Cartinine 25/50/50/1/50MG/ML MDV INJ, Rx Only, 30ml, Red Mountain Compounding Rx.
D-0278-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2x30ml glass vials
- Official record key
drug-enforcement:D-0278-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S07092019DT@19, Exp 08/09/2019, S07292019DH@09, Exp 08/29/2019,
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility