Drug product
RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0.4 mL OPTH PF; NDC/UPC 23916330; RX
D-0416-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3688 bottles
- Official record key
drug-enforcement:D-0416-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: T1202
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations