Drug product
S-HCG 3000 U/ML MDV SOLN, 10 ML glass vials, Rx Only, Red Mountain Compounding Rx.
D-0265-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8x10 ML vials
- Official record key
drug-enforcement:D-0265-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S06272019DT@07, Exp 8/27/19; S07262019DH@04, Exp 9/26/19; S07302019DH@04, Exp 9/30/19;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility