Drug product
Natural Ophthalmics Ortho-K Thin Eye Drops, 15 mL, NDC 68770-144-15
D-0464-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 84216 units
- Official record key
drug-enforcement:D-0464-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 17375 12/19 17376 12/19 18190 7/20 18191 8/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility