Drug product
LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL
D-0443-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 463 boxes
- Official record key
drug-enforcement:D-0443-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 352162
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations