Drug product
Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), 1/2 fl oz 15 mL, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-182-13
D-0426-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 202266 units
- Official record key
drug-enforcement:D-0426-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 17112 4/20 17303 10/20 18032 2/21 18072 3/21 18193 8/20 18235 9/21 18285 11/21 19004 1/22 19102 4/22 16260 9/19
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility