Drug product
FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15
D-0483-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 31070 units
- Official record key
drug-enforcement:D-0483-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 18095, Exp 4/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility