Drug product
S-FOLIC ACID 10MG/ML MDV INJ; packaged in 30ml glass vials, Rx Only, Red Mountain Compounding RX.
D-0220-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5x30 ml glass vials
- Official record key
drug-enforcement:D-0220-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S06162019DH@09, Exp 9/16/19; S06032019DT@01, Exp 9/30/19;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility