Drug product
S-DEXPANTHENOL 250MG/ML MDV INJ SOLN, 30ML glass vials, RX Only, Red Mountain Compounding RX
D-0211-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37x30 ml glass vials
- Official record key
drug-enforcement:D-0211-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S03072019DH@08; Exp 9/7/19; S02142019DH@08, Exp 8/14/19; S03072019DH@07, Exp 9/7/19; 03072019DH@08, 9/7/19; S03042019DH@07, Exp 9/4/19, S04172019DT@02, Exp 10/17/19; S05232019DT@10, Exp 11/23/19; S06242019DH@10, Exp 12/24/19; S07172019DT@07, Exp 1/17/20; S07242019DH@09, Exp 1/24/20
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility