Drug product
TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPS
D-0425-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 325 CARTONS
- Official record key
drug-enforcement:D-0425-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: RW4409
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations