Drug product
Altaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05
D-0478-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 6024 units
- Official record key
drug-enforcement:D-0478-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: 18164, Exp 7/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility