Drug product
Altaire Sterile Eye Wash, 118 mL (4 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-35
D-0425-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 809,600 units
- Official record key
drug-enforcement:D-0425-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 17087 3/20 17088 3/20 17109 4/20 17110 4/20 17306 10/20 17307 10/20 17318 10/20 17323 10/20 18014 1/21 18045 2/21 18059 3/21 18063 3/21 18117 5/21 18134 5/21 18228 9/21 18261 10/21 19119 4/22 16207 8/19 16233 8/19 16250 9/19 16268 10/19 16301 11/19
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility