Drug product
S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. Red Mountain Compounding Rx.
D-0257-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16x5 and 10 ml glass vials
- Official record key
drug-enforcement:D-0257-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S04092019DT@16, Exp 8/9/19; S05012019DT@08, Exp 9/1/19; S05152019DT@01, Exp 9/15/19; S06112019DH@18, Exp 10/11/19; S06122019DT@06, Exp 10/12/19; S06192019DT@10, Exp 10/19/19; s07092019dt@16, Exp 11/9/19; S07242019DH@10, Exp 11/24/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility