Drug product
Natural Ophthalmics Ortho-K Thick Comfort Gel, 15 mL, NDC 68770-143-15
D-0462-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 81969 units
- Official record key
drug-enforcement:D-0462-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 17210 7/19 17378 12/19 18175 7/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility