Drug product
S-VIT B COMPLEX INJ SOLN (HP); Rx Only, 30ML glass vial, Red Mountain Compounding Rx
D-0293-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46 x30 ML glass vials
- Official record key
drug-enforcement:D-0293-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #:S04102019DT@09, Exp 8/10/19; S05012019DT@03, Exp 9/1/19; S05162019DH@21, Exp 9/16/19; S05152019DH@21,Exp 9/16/19; S06162019DH@14, Exp 10/16/19; S06262019DT@03, Exp 10/26/19; S06262019DT@10, Exp 10/26/19; S07252019DH@11, Exp 11/25/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility