Drug product
S-GAT/KLAC/LIDO/PHE/TPMD 0.036/0.036/1.42/0.71/0.071%, OPTH GEL, 5ML dropper bottle, Red Mountain Compounding RX.
D-0221-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 5ml bottle
- Official record key
drug-enforcement:D-0221-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S07292019DH@08, Exp 9/29/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility