Drug product
Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750-14 Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134
D-0534-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 348 droptainers
- Official record key
drug-enforcement:D-0534-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 10CPE
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations