Drug product
Altaire Sterile Eye Wash, 30 mL (1 fl oz.), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-18
D-0424-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 414,346 units
- Official record key
drug-enforcement:D-0424-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 17200 7/19 17322 10/20 18026 1/21 18100 4/21 18236 9/21 19052 2/22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility