Drug product
OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS
D-0408-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 339 bottles
- Official record key
drug-enforcement:D-0408-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 427297
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations