Drug product
S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain Compounding RX
D-0200-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2x 10 ml bottles
- Official record key
drug-enforcement:D-0200-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S07222019DH@09, Exp 8/22/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility