Drug product
Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, 10 mL, Rx only, Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-217-10
D-0420-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 636 units
- Official record key
drug-enforcement:D-0420-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 18164 7/20
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility