Drug product
S-PHENOL 6% INJ SOLN, Rx Only 10ml glass vial, Red Mountain Compounding Rx.
D-0243-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3x10 ml glass vials
- Official record key
drug-enforcement:D-0243-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S06242019DH@08, Exp 9/24/19; S07242019DH@08, Exp 10/24/19; S07312019DH@03, Exp 10/31/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility