Drug product
S-PYRIDOXINE HCL (B6) 100MG/ML MDV, Rx Only, 30ml glass vial. Red Mountain Compounding Rx.
D-0247-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38x30 ml glass vials
- Official record key
drug-enforcement:D-0247-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S03072019DH@10, Exp 9/7/19; S04162019DT@18, Exp 10/16/19; S05162019DH@09, Exp 11/16/19; S05232019DT@11, Exp 11/23/19; s06182019dh@31, Exp 12/18/19; S06242019DH@14, Exp 12/24/19; S07172019DT@08, Exp 1/17/20; S07232019DH@16, Exp 1/23/20; S06242019DH@14, Exp 12/24/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility