Drug product
S-FOLIC ACID 20MG/ML MDV INJ, packaged in a)10ml b) 30ml, glass vials, Rx Only, Red Mountain Compounding Rx.
D-0264-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1x10, 1x30 ml glass vials
- Official record key
drug-enforcement:D-0264-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot# S05162019DH@17, Exp 8/26/19; S07262019DH@08, Exp 10/26/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility