Drug product
iSolutions ActivEyes Nighttime Lubricant Eye Ointment Preservative Free, Sterile, Net Wt: 3.5 g (1.8 oz), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-190-50
D-0414-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 6,877 units
- Official record key
drug-enforcement:D-0414-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: SKG 11/21 12/28/2018 TAQ 01/22 04/23/2019
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility