Drug product
Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-175-13
D-0423-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 48,542 units
- Official record key
drug-enforcement:D-0423-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 17241 8/20 8/24/2017 17322 10/20 12/21/2017 18169 7/20 7/30/2018 19052 2/22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility